Pfizer submits data to US for COVID-19 vaccine in younger children

Pfizer Inc and BioNTech SE submitted initial trial data for their COVID-19 vaccine in children aged 5 to 11 to US regulators on Tuesday and said they would make a formal request for emergency use authorization in the coming weeks.

Coronavirus infections have soared in children and hit their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, has been shown to induce a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.

The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, kids could start receiving their shots as soon as late October.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness. 

-reuters-

Sinovac, Pfizer/BioNtech COVID-19 vaccines prove highly effective in Uruguay -government

ASUNCION - Uruguay on Tuesday released real-world data on the impact of Sinovac Biotech's COVID-19 vaccine among its population that showed it was over 90% effective in preventing intensive care admissions and deaths.

The shot reduced deaths by 95% and intensive care admissions by 92%, and also showed 61% efficacy in cutting coronavirus infections, the government said.

A total of 795,684 people - health workers and members of the general population between the ages of 18 and 69 - at least 14 days after receiving their second dose of Sinovac's CoronaVac were compared to unvaccinated people to determine the real-world vaccine effectiveness, the government said in a report.

The government also studied the effectiveness of the Pfizer/BioNTech vaccine among 162,047 health workers and people over 80 years old. The shot was 94% effective at preventing intensive care unit admissions and deaths, and reduced infections by 78%, the report said.

Overall, intensive care hospitalizations and deaths from COVID-19 dropped by more than 90% among Uruguayans who were fully inoculated, the data showed.

The tiny Latin nation with a population of 3.5 million managed to largely hold COVID-19 at bay with a strict lockdown last year. This year, it has seen a spike in cases that in recent weeks propelled it to the ranks of countries with the highest COVID-19 death rates per million, according to Our World in Data figures.

So far, it has vaccinated almost 52% of its population with at least one dose of COVID-19 vaccine from Sinovac, Pfizer/BioNTech or AstraZeneca, received through the COVAX vaccine alliance, while 29% had been fully vaccinated, between the end of February and June 1, according to Ministry of Health data. 

Uruguay has registered 318,783 cases of COVID-19 since March 2020 and 4,692 associated deaths. 

-reuters-

Pfizer, Moderna vaccines effective against Indian variants: study

WASHINGTON - The Pfizer and Moderna COVID vaccines should remain highly effective against two coronavirus variants first identified in India, according to new research carried out by US scientists.

The lab-based study was carried out by the NYU Grossman School of Medicine and NYU Langone Center and is considered preliminary because it has not yet been published in a peer-reviewed journal.

"What we found is that the vaccine's antibodies are a little bit weaker against the variants, but not enough that we think it would have much of an effect on the protective ability of the vaccines," senior author Nathaniel "Ned" Landau told AFP on Monday.

The researchers first took blood from people who were vaccinated with either of the two shots, which are predominant in the United States and have been given to more than 150 million Americans.

They then exposed these samples in a lab to engineered pseudovirus particles that contained mutations in the "spike" region of the coronavirus, which were particular to either the B.1.617 or B.1.618 variants, first found in India.

Finally, that mixture was exposed to lab-grown cells, to see how many would become infected.

The engineered pseudovirus particles contained an enzyme called luciferase, which fireflies use to light up. Adding it to the pseudovirus makes it possible to tell how many cells are infected, based on light measurements.

Overall, for B.1.617 they found an almost four-fold reduction in the amount of neutralizing antibodies -- Y-shaped proteins the immune system creates to stop pathogens from invading cells. For B.1.618, the reduction was around three-fold.

"In other words, some of the antibodies now don't work anymore against the variants, but you still have a lot of antibodies that do work against the variants," said Landau.

"There's enough that do work that we believe that the vaccines will be highly protective," he added, because the overall levels remain well above those found in samples taken from people who recovered from infection with earlier unmutated virus.

But this kind of lab investigation cannot predict what the real world efficacy might look like -- that will have to be investigated through other studies.

The coronavirus is known to latch on to a particular receptor on human cells called ACE2, which it uses to force its entry.

Landau's team showed the Indian variants were able to bind more tightly to this receptor, like other variants of concern. This might be linked to its increased transmissibility compared to the original strain.

"Our results lend confidence that current vaccines will provide protection against variants identified to date," the team concluded. 

However, they do not preclude the possibility that newer variants that are more resistant to vaccines will emerge -- highlighting the importance of widespread vaccination at the global level.

Agence France-Presse

S.Korea says AstraZeneca, Pfizer COVID-19 vaccines 87% effective after first shot

SEOUL - One dose of COVID-19 vaccines from AstraZeneca Plc and Pfizer was 86.6 percent effective in preventing infections among people aged 60 and older, real world data released by South Korea showed on Wednesday.

Data by the Korea Disease Control and Prevention Agency (KDCA) showed the Pfizer vaccine, jointly developed by BioNTech, was 89.7 percent effective in preventing infection at least two weeks after a first dose was given, while the AstraZeneca shot was 86.0 percent effective.

Its analysis is based on more than 3.5 million people in South Korea aged 60 and older for two months from Feb. 26 and included 521,133 people who received a first dose of either Pfizer or AstraZeneca shot.

There were 1,237 COVID-19 cases in the data and only 29 were from the vaccinated group, the KDCA said.

"It is shown that both vaccines provide a high protection against the disease after the first dose. (People) should get full vaccinations according to recommended schedule, as the protection rate will go up further after a second dose," it said.

The findings come as South Korea seeks to drum up participation in its immunization drive after reports about potential safety issues discouraged some people from getting vaccinated.

"Around 95 percent of people who died from the coronavirus in our country were senior citizens aged 60 or older, and the vaccines will sharply lower risks for those people," health ministry official Yoon Tae-ho told a briefing on Wednesday.

Yoon said the possibility of side effects including blood clotting are "extremely low" and they are mostly curable.

South Korea has so far vaccinated 6.7 percent of its 52 million strong population, but has set an ambitious target of giving shots to 70 percent of its people by September and reaching herd immunity by November.

Starting on Wednesday, South Koreans who are fully vaccinated and show a negative COVID-19 test and no symptoms will be exempted from the two-week mandatory quarantine upon their return from overseas travel, to encourage more vaccinations.

The KDCA reported 676 new COVID-19 cases as of midnight on Tuesday, bringing the country's total infections to 124,945, with 1,847 deaths.

-reuters-

Philippines, Brazil, Mexico among those due to get Pfizer shots from COVAX in Q2

GENEVA - Some 14.1 million doses of the Pfizer BioNTech COVID-19 vaccine have been allocated to 47 countries and economies for delivery in the second quarter of this year, the Gavi Vaccine Alliance said on Monday.

Brazil, Colombia, Mexico, the Philippines, South Africa, and Ukraine are set to be among the main recipients of the Pfizer vaccine between April and June, according to Gavi, which co-leads the COVAX facility with the World Health Organization (WHO) and other partners.

The COVAX program offers a lifeline to low-income countries in particular, allowing them to inoculate health workers and others at high risk, even if their governments have not managed to secure vaccines from the manufacturers.

Australia, Britain, Kuwait, and the United Arab Emirates are due to receive their first shots via COVAX with the Pfizer doses, which is "based on current knowledge of COVID-19 vaccine supply availability", Gavi said in a statement.

The program delivered nearly 38.4 million doses of COVID-19 vaccines to 102 countries across six continents, six weeks after it began to roll out supplies, Gavi said last Thursday.

Deliveries of the AstraZeneca vaccine to 142 participants under a previously announced round were underway, "with some delays" that may extend deliveries past May, Gavi said on Monday.

Reduced availability delayed some deliveries in March and April, and much of the output of the Serum Institute of India, which makes the AstraZeneca vaccine, is being kept in India, where the number of daily infections is spiraling.

The chief executive of Gavi, Seth Berkley, said last Friday that COVAX aimed to deliver one third of a billion COVID-19 doses by mid-year, on the way to more than 2 billion in 2021.

-reuters-

South African variant can 'break through' Pfizer vaccine, Israeli study says

JERUSALEM - The coronavirus variant discovered in South Africa can "break through" Pfizer/BioNTech's COVID-19 vaccine to some extent, a real-world data study in Israel found, though its prevalence in the country is low and the research has not been peer reviewed.

The study, released on Saturday, compared almost 400 people who had tested positive for COVID-19, 14 days or more after they received one or two doses of the vaccine, against the same number of unvaccinated patients with the disease. It matched age and gender, among other characteristics.

The South African variant, B.1.351, was found to make up about 1% of all the COVID-19 cases across all the people studied, according to the study by Tel Aviv University and Israel's largest healthcare provider, Clalit.

But among patients who had received two doses of the vaccine, the variant's prevalence rate was eight times higher than those unvaccinated - 5.4% versus 0.7%.

This suggests the vaccine is less effective against the South African variant, compared with the original coronavirus and a variant first identified in Britain that has come to comprise nearly all COVID-19 cases in Israel, the researchers said.

"We found a disproportionately higher rate of the South African variant among people vaccinated with a second dose, compared to the unvaccinated group. This means that the South African variant is able, to some extent, to break through the vaccine's protection," said Tel Aviv University's Adi Stern.

The researchers cautioned, though, that the study only had a small sample size of people infected with the South African variant because of its rarity in Israel.

They also said the research was not intended to deduce overall vaccine effectiveness against any variant, since it only looked at people who had already tested positive for COVID-19, not at overall infection rates.

Pfizer and BioNTech could not be immediately reached for comment outside business hours.

The companies said on April 1 that their vaccine was around 91% effective at preventing COVID-19, citing updated trial data that included participants inoculated for up to six months.

In respect to the South African variant, they said that among a group of 800 study volunteers in South Africa, where B.1.351 is widespread, there were nine cases of COVID-19, all of which occurred among participants who got the placebo. Of those nine cases, six were among individuals infected with the South African variant.

Some previous studies have indicated that the Pfizer/BioNTech shot was less potent against the B.1.351 variant than against other variants of the coronavirus, but still offered a robust defense.

While the results of the study may cause concern, the low prevalence of the South African strain was encouraging, according to Stern.

"Even if the South African variant does break through the vaccine's protection, it has not spread widely through the population," said Stern, adding that the British variant may be "blocking" the spread of the South African strain.

Almost 53% of Israel's 9.3 million population has received both Pfizer doses. Israel has largely reopened its economy in recent weeks while the pandemic appears to be receding, with infection rates, severe illness and hospitalizations dropping sharply. About a third of Israelis are below the age of 16, which means they are still not eligible for the shot. 

-reuters-

English survey finds high antibody levels from Pfizer vaccine rollout

LONDON - People in England who have received 2 doses of Pfizer's COVID-19 vaccine are generating strong antibody responses as the shot is rolled out, researchers said Thursday, adding that confidence in vaccines was high.

An Imperial College London survey showed 87.9 percent of people over the age of 80 tested positive for antibodies after 2 doses of the Pfizer-BioNTech vaccine, rising to 95.5 percent for those under the age of 60 and 100 percent in those aged under 30.

"Although there is some fall-off in positivity with age, at all ages, we get that very good response to 2 doses of the vaccine," Paul Elliott, Chair in Epidemiology and Public Health Medicine, Imperial College London, told reporters.

Antibody levels are only one part of the immunity picture, with vaccines also shown to generate strong T-cell protection.

Nearly 95 percent of under-30s tested positive for antibodies 21 days after 1 dose, but this fell in older groups.

The research found 34.7 percent of those 80 years or older generated antibody responses from 1 dose of the Pfizer vaccine, but Britain's Joint Committee on Vaccination and Immunization (JCVI) has previously found high protection from the Pfizer vaccine after 1 dose, even when antibody levels are lower.

Britain has extended the gap between doses to 12 weeks, even though Pfizer has cautioned it only has data for clinical efficacy with a 3-week gap between shots.

Over 154,000 participants took part in Imperial's home surveillance study for COVID-19 antibodies, which monitors antibody levels from natural infection as well as among the vaccinated, between Jan. 26 and Feb. 8.

The survey also looked at confidence in vaccines, and showed it was high, with 92 percent having accepted or were planning to accept a vaccine offer, though confidence was lower among Black people, dropping to 72.5 percent.

-reuters-

Malaysia to start COVID-19 vaccination drive early as first doses arrive

KUALA LUMPUR - Malaysia moved up its COVID-19 inoculation drive by two days as the first batch of vaccines arrived in the Southeast Asian nation on Sunday.

Malaysia aims to vaccinate at least 80% of its 32 million people within a year as it pushes to revive an economy that, slammed by coronavirus-related curbs, recorded its worst slump in over two decades in 2020.

It has imposed more lockdowns this year amid a fresh wave of coronavirus infections. The country has recorded 280,272 cases and 1,051 deaths.

A total of 312,390 doses of the Pfizer-BioNTech vaccine were delivered to Malaysia on Sunday morning, with more expected in coming weeks.

"The second delivery will be made on Feb. 26, and we will continue to receive (Pfizer) deliveries every two weeks until it is completed," Science Minister Khairy Jamaluddin said in a virtual news conference.

Malaysia has secured 32 million doses from Pfizer and BioNTech.

Vaccine doses from China's Sinovac Biotech are scheduled to be delivered in bulk on Feb. 27, pending approval from local regulators, Khairy said.

The national vaccine rollout will begin Wednesday, earlier than initially scheduled, with Prime Minister Muhyiddin Yassin and Health Ministry Director General Noor Hisham Abdullah set to receive the first doses, Khairy said.

-reuters-

Pfizer says South African variant could significantly reduce vaccine protection

A laboratory study suggests that the South African variant of the coronavirus may reduce antibody protection from the Pfizer Inc/BioNTech SE vaccine by two-thirds, and it is not clear if the shot will be effective against the mutation, the companies said on Wednesday.

The study found the vaccine was still able to neutralize the virus and there is not yet evidence from trials in people that the variant reduces vaccine protection, the companies said.

Still, they are making investments and talking to regulators about developing an updated version of their mRNA vaccine or a booster shot, if needed.

For the study, scientists from the companies and the University of Texas Medical Branch (UTMB) developed an engineered virus that contained the same mutations carried on the spike portion of the highly contagious coronavirus variant first discovered in South Africa, known as B.1.351. The spike, used by the virus to enter human cells, is the primary target of many COVID-19 vaccines.

Researchers tested the engineered virus against blood taken from people who had been given the vaccine, and found a two- thirds reduction in the level of neutralizing antibodies compared with its effect on the most common version of the virus prevalent in U.S. trials.

Their findings were published in the New England Journal of Medicine (NEJM).

Because there is no established benchmark yet to determine what level of antibodies are needed to protect against the virus, it is unclear whether that two-thirds reduction will render the vaccine ineffective against the variant spreading around the world.

However, UTMB professor and study co-author Pei-Yong Shi said he believes the Pfizer vaccine will likely be protective against the variant.

"We don't know what the minimum neutralizing number is. We don't have that cutoff line," he said, adding that he suspects the immune response observed is likely to be significantly above where it needs to be to provide protection.

That is because in clinical trials, both the Pfizer/BioNTech vaccine and a similar shot from Moderna Inc conferred some protection after a single dose with an antibody response lower than the reduced levels caused by the South African variant in the laboratory study.

Even if the concerning variant significantly reduces effectiveness, the vaccine should still help protect against severe disease and death, he noted. Health experts have said that is the most important factor in keeping stretched healthcare systems from becoming overwhelmed.

More work is needed to understand whether the vaccine works against the South African variant, Shi said, including clinical trials and the development of correlates of protection - the benchmarks to determine what antibody levels are protective.

Pfizer and BioNTech said they were doing similar lab work to understand whether their vaccine is effective against another variant first found in Brazil.

Moderna published a correspondence in NEJM on Wednesday with similar data previously disclosed elsewhere that showed a sixfold drop antibody levels versus the South African variant.

Moderna also said the actual efficacy of its vaccine against the South African variant is yet to be determined. The company has previously said it believes the vaccine will work against the variant. 

-reuters-

Japan launches COVID-19 vaccinations as Olympics approach

TOKYO - Japan began administering COVID-19 vaccinations on Wednesday, starting with health workers in Tokyo before expanding the rollout nationwide as the clock ticks down to the Summer Olympics.

The country has been slow to launch inoculations against the coronavirus, starting its program later than at least 70 other countries as Prime Minister Yoshihide Suga's public support dwindles amid criticism of a sluggish pandemic response.

Speaking in a parliamentary committee meeting, Suga reiterated that vaccines will be the "decisive factor" in fighting the coronavirus and vowed to move forward with the rollout while keeping the public informed.

Vaccinations are due to take place at 100 medical facilities across the country by next week, with specialized freezers already in place to store the vaccine developed by US drugmaker Pfizer Inc. and Germany's BioNTech SE at subzero temperatures.

Of the initial group of 40,000 health workers, 20,000 will participate in a study to track side effects potentially caused by the vaccine and the frequency with which they occur.

They will be asked to keep daily records for 7 weeks after taking the first of 2 shots. The shots will be administered 3 weeks apart.

Twelve staff, including 3 doctors and 5 nurses at the state-run Tokyo Medical Center, were inoculated on Wednesday with none immediately feeling any side effects.

Hospital head Kazuhiro Araki, who was first in the country to receive the shot, said he hopes participating in the study will "help both staff and patients prevent infections."

A further 3.7 million front-line health workers are to begin being inoculated in March, followed by 36 million people aged 65 or older from April.

People with preexisting conditions such as diabetes or heart disease and those working at elderly care facilities will come next, and then finally the general population.

The minister in charge of vaccination efforts, Taro Kono, said Tuesday that foreign residents will become eligible for the free shots in the same order of priority as Japanese citizens, as long as they are registered with a municipality.

Japan received the first shipment of about 386,000 doses from Pfizer's factory in Belgium last week and granted fast-track approval for domestic use on Sunday.

Kono told a press conference that the second shipment had been cleared by the European Union under its new vaccine export controls and was expected to arrive next week, but declined to say how many doses it would contain.

-Kyodo News-

Gandalf actor Ian McKellen euphoric after receiving COVID-19 vaccine

LONDON -- British actor Ian McKellen, who played the wizard Gandalf in the "Lord of the Rings" movies, said he was euphoric after receiving his first dose of the Pfizer COVID-19 vaccine and urged everyone who was offered the jab to accept it.

The state-run National Health Service (NHS), which is running Britain’s mass COVID vaccination program, posted several pictures of McKellen, in a blue T-shirt and a rainbow striped scarf, giving a thumbs up as he received the shot.

“It’s a very special day. I feel euphoric,” McKellen, 81, was quoted as saying in one NHS post which he retweeted.

“I would have no hesitation in recommending it to anyone. I feel very lucky to have had the vaccination.”

Nearly 140,000 people have received their first dose of the Pfizer vaccine in Britain since roll out began on Dec. 8. People aged over 80 are in the highest priority group.

A star of British stage and screen since the 1960s, McKellen attained a new level of global fame in the 2000s when he appeared as Gandalf in the movies based on J.R.R. Tolkien’s novels and directed by Peter Jackson.

He was the latest British celebrity to go public about receiving the COVID-19 vaccine, part of a collective effort to reassure members of the public who may be harbouring doubts about the jab’s safety.

The chef and cookery writer Prue Leith, 80, who presents the high-ratings TV show “The Great British Bake Off”, also posted a picture of herself receiving the shot.

It is not known whether Queen Elizabeth, 94, and her husband Prince Philip, 99, have had the vaccine yet. The Times reported they may “let it be known” once they have.

The queen is highly respected in Britain and her backing would be a powerful message to counter anti-vaccination misinformation.

-reuters-

US to start vaccinating as Germany returns to partial lockdown

KALAMAZOO, US - The United States prepared to start its Covid-19 vaccination program on Monday as the nation's death toll edged towards 300,000, while Germany announced a partial lockdown over the holidays due to an explosion of cases.

Delivery trucks with special refrigeration equipment rolled out of a facility in Kalamazoo, Michigan, on Sunday as part of a public-private plan to ship millions of doses of the newly approved Pfizer-BioNtech vaccine to vulnerable Americans.

Courier services FedEx and UPS have deployed fleets of trucks and planes to carry their precious cargo -- sometimes under armed guard -- to all 50 states, where healthcare workers and nursing-home residents will be first in line.

"Vaccines are shipped and on their way," President Donald Trump tweeted. "Get well USA. Get well WORLD."

One state governor, Andy Beshear of Kentucky, said that "we now believe that the first individuals will be vaccinated" on Monday -- less than 72 hours after the vaccine received emergency authorization from the US Food and Drug Administration.

An initial 2.9 million doses are set to be delivered by Wednesday, with officials saying 20 million Americans could receive the two-shot regimen by year end, and 100 million by March.

But the breakthrough comes at one of the darkest moments of the pandemic, with infections in the United States and many other countries soaring, and health experts still struggling against vaccine skepticism, lockdown fatigue and uneven adherence to safety rules.

GRIM US DEATH TOLL

The US has the world's highest death toll of more than 299,000, and the largest number of cases, at 16.2 million -- including more than 1.5 million new cases in just the past week.

Worldwide, there have been at least 1.6 million deaths since the outbreak emerged in China last December, and 71.6 million cases overall.

The start of vaccination campaigns this week in the US -- and also Canada -- came as Germany announced a partial lockdown from Wednesday, with non-essential shops and schools to close in a bid to halt an "exponential growth" in infections.

The restrictions, agreed by Chancellor Angela Merkel and regional leaders, will apply through the holidays until January 10. 

Europe's biggest economy has been severely hit by a resurgence of the coronavirus, with daily new infections more than three times their springtime peak. Daily death tolls last week approached 600.

Germany's hardest-hit states had already ordered new measures. Saxony state, where in some areas incidence rates have hit 500 per 100,000 people, will shutter shops and schools from Monday.

Italy, meanwhile, overtook Britain as the European nation with the highest death toll.

"I am worried about the two weeks of Christmas holidays... The battle still has not been won," Italian Health Minister Roberto Speranza warned as the country recorded 64,520 deaths, surpassing Britain's 64,267.

Elsewhere, the prime minister of the small African nation of Eswatini died in a South African hospital on Sunday, two weeks after contracting coronavirus.

In Algeria, 75-year-old President Abdelmadjid Tebboune made his first televised appearance since being hospitalized with Covid-19 in October.

"Thanks to God," he said, "I have started on the road to recovery." 

And President Jair Bolsonaro of Brazil faced scathing criticism over his government's plan -- or lack thereof -- to vaccinate the population.

Brazil, the country with the world's second-highest death toll, published its vaccination policy on Saturday under pressure from the Supreme Court, but listed no start date or details of how it would secure sufficient doses.

Leading newspaper Folha de Sao Paulo, in a scathing front-page editorial, said virus-skeptic Bolsonaro had shown "murderous stupidity."

South Korea -- once seen as a model of how to combat the pandemic -- on Sunday reported 1,030 new coronavirus cases, a record high for a second day in a row.

'DON'T LET YOUR GUARD DOWN'

Even as US health experts welcomed the unprecedented vaccine effort, they cautioned people not to grow lax in observing precautions.

"The next number of weeks are going to be hell, I fear," New Jersey Governor Phil Murphy told ABC's "This Week." 

"So we're begging people to please, please, please don't let your guard down."

UPS and FedEx are to ship glass vials of the vaccine to 636 sites around the country by Wednesday.

Doses are being shipped in boxes containing dry ice that can keep supplies at -70 degrees Celsius (-94 degrees Fahrenheit), the frigid temperature needed to preserve the drug.

Trials have shown the vaccine to be 95 percent effective, and Americans are being told it is safe unless they have an allergy to any of the drug's components.

The US National Security Council said Sunday that senior federal officials will be among those given priority access to keep the government functioning, but Trump later tweeted that government workers should be vaccinated "somewhat later in the program, unless specifically necessary."

"I am not scheduled to take the vaccine, but look forward to doing so at the appropriate time," he said.

Agence France-Presse

UK starts mass COVID vaccination program

LONDON - Britain on Tuesday hailed a turning point in the fight against the coronavirus pandemic, as it begins the biggest vaccination program in the country's history with a new COVID-19 jab.

The first patients in line on what has been dubbed "V-Day" -- the over-80s, care home workers and at-risk frontline health and social care staff -- will roll up their sleeves for an initial dose from early morning.

They will then require a second jab in 21 days' time.

Last week, Britain became the first country to approve the Pfizer-BioNTech vaccine, raising hopes of a breakthrough in the pandemic, which has killed more than 1.5 million worldwide.

Britain has been one of the worst-affected countries in the world, with more than 61,000 deaths in the outbreak from 1.6 million cases.

Prime Minister Boris Johnson, who spent days in intensive care with COVID-19 earlier this year, called it a "huge step forward in the UK's fight against coronavirus."

UK Health Secretary Matt Hancock, who has offered to have the jab on live television to allay public fears, said the rollout was a "key moment" that would protect the most vulnerable.

The head of the state-run National Health Service in England, Simon Stevens, said it was a "decisive turning point" against the "greatest health challenge" since the NHS was founded in 1948.

Regulatory approval for the vaccine was given last Wednesday, sparking a race against time to prepare scores of vaccination centers across the country.

The UK has ordered 40 million doses of the jab -- enough to vaccinate 20 million people -- with 800,000 in the first batch.

Up to 4 million doses are expected by the end of December.

QUEEN COULD LEAD WAY

The mass vaccination drive is a coordinated response by all 4 nations of the UK -- England, Scotland, Wales and Northern Ireland -- which normally set their own health policies.

The public has been largely favorable to the rapid approval of the vaccine, but ministers and health professionals are aware they still need to combat mistrust.

The independent Medicines and Healthcare products Regulatory Agency maintains that no corners were cut and its assessment and approval procedures met stringent international norms.

NHS England said thousands had already been given the jab during trials with no serious side effects.

Nevertheless, it has been reported Queen Elizabeth II, who at 94 is among those first in the line for the vaccination because of her age, could front a public awareness campaign urging compliance.

The government said it will hand out vaccine cards to remind people to get the booster after 3 weeks, but insisted it was not introducing immunity certificates.

'MARGINAL IMPACT' IN WINTER

The chief medical officers of England, Scotland, Wales and Northern Ireland said the vaccine will as a result only have a "marginal impact" on hospital numbers over the winter months.

Johnson called for patience and urged the public to stick to strict social distancing guidelines to prevent a spike in cases, particular as rules are relaxed over Christmas.

Health officials have already run into a logistical headache about how to administer the vaccine to elderly or infirm care home residents.

The vaccine needs to be stored at -70 degrees Celsius (-94 Fahrenheit), leaving hospitals and other medical hubs as the only places able to deal with such ultra-low temperatures.

With the Pfizer-BioNTech drug made in Belgium, concerns have also been raised about potential disruption to supply when Britain leaves the European Union's single market and customs union.

But the UK government said the military is on stand-by to air-lift the vaccine if there is any border disruption from Jan. 1.

The bulk of Britain's vaccine requirements are expected to be met by a jab developed by AstraZeneca and the University of Oxford, which is awaiting regulatory approval.

The government has ordered an initial 100 million doses of the drug, which is cheaper to manufacture, and easier to store and transport using conventional fridges.

Agence France-Presse

Pfizer to deliver first vaccine doses to Canada this month: Trudeau

OTTAWA — Pfizer and BioNTech will deliver the first doses of their COVID-19 vaccine to Canada this month, Prime Minister Justin Trudeau announced Monday, with inoculations to start as early as next week.

Another vaccine candidate developed by Moderna could also be shipped "as soon as December," the American company said.

At a news conference, Trudeau said a deal was signed with Pfizer and BioNTech "to begin early delivery of doses of their vaccine candidate." 

"We are now contracted to receive up to 249,000 of our initial doses of Pfizer BioNTech's COVID-19 vaccine in the month of December," he said.

Pending regulatory approval expected this week, the prime minister said the first shipments to 14 sites across Canada could be delivered next week, with millions more doses to follow in 2021.

Health care workers and vulnerable populations including the elderly would be the first to receive it.

Major-General Dany Fortin, who is leading Canada's COVID-19 vaccine rollout, said it will take only one or two days after the doses arrive to "unpack, thaw, decant, mix" and inject them into the arms of Canadians. 

He and his team are doing a "dry run" to test the ultra-cold storage delivery chain, flying boxes this week from Belgium and handing them off to health care workers.

The federal government has concluded pre-orders with several pharmaceutical companies -- including AstraZeneca, Pfizer and BioNTech, Sanofi and GSK, Novavax, Johnson & Johnson, Medicago and Moderna -- for 400 million doses, to ensure it eventually gets what it needs for its population of 38 million.

The vaccine developed by US giant Pfizer and its German partner BioNTech is at the most advanced stage, having proved 95 percent effective in late-stage clinical trials and already secured approval in Britain where its world-first rollout is to begin Tuesday.

In August, Ottawa signed a deal with Pfizer for 20 million doses plus options for more.

Agence France-Presse

Australia aims to complete review of Pfizer's COVID-19 vaccine by January

SYDNEY - Australia's pharmaceutical regulator said on Thursday it is on course to review Pfizer's COVID-19 vaccine by January 2021, with the country sticking to a March timetable to start vaccinations.

Britain on Wednesday approved the use of the Pfizer vaccine, jumping ahead of the rest of the world in the race to begin the most crucial mass inoculation program in history.

But John Skerritt, the head of Australia's Therapeutic Goods Administration (TGA) said it would likely complete its review by "late January" and has told staff not to plan a holiday to get the work done.

"My staff have been told to put away their swimsuits and towels and to work as quickly as we can but also in significant depth," Skerritt told reporters in Canberra.

Pfizer's is one of the four COVID-19 vaccines Australia has agreed to buy, including from Novavax, AstraZeneca and CSL Ltd, should trials prove successful.

Health Minister Greg Hunt said the January timetable does not accelerate plans to begin vaccinations.

"We are on track for first vaccinations beginning with our health workers and our aged care residents subject to approvals in March," Hunt told reporters in Canberra.

Treasurer Josh Frydenberg said getting a vaccine out by then would boost the country's economy by A$34 billion ($25 billion) compared with earlier assumptions of 2022.

Australia is in the fortunate position of being able to allow regulators time to complete checks without the pressure of mounting cases of COVID-19.

Its tally of more than 27,800 infections is far fewer than many other developed countries, and until Wednesday gone nearly three weeks without any local transmission of COVID-19.

The streak was broken when Australia's most populous state said a worker at a hotel, where overseas travelers are quarantined for two weeks, tested positive for COVID-19.

-reuters-

UK approves Pfizer-BioNTech COVID-19 vaccine, first in the world

LONDON — Britain on Wednesday became the first country in the world to approve the Pfizer-BioNTech COVID-19 vaccine for use and said that it will be rolled out from early next week.

"The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use," the government said.

"The vaccine will be made available across the UK from next week."

Pfizer said Britain's emergency use authorization marks a historic moment in the fight against COVID-19.

"This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” said CEO Albert Bourla.

British Health Secretary Matt Hancock said he was very proud that the United Kingdom had become the first place in the world to have a clinically authorized coronavirus vaccine.

"I'm obviously absolutely thrilled with the news. I'm very proud that the UK is the first place in the world to have a clinically authorized vaccine ready to go," he told BBC TV. 

-reuters-

When and which COVID-19 vaccines are likely to be available in Asia Pacific

Pfizer Inc with partner BioNTech SE, Moderna Inc and AstraZeneca Plc have released trial data this month showing their experimental vaccines are effective in preventing the disease.

If regulators approve any of the vaccines in coming weeks, the companies have said distribution could begin almost immediately with governments around the world.

But many Asian countries do not expect to receive big amounts initially, and below are estimated distribution timelines, supply deals announced so far and clinical trials under way in the region.

PHILIPPINES

It is in talks with AstraZeneca for the supply of at least 20 million doses, which may arrive in the country in the second quarter of next year. It hopes to lock in 60 million doses in total and also is in talks with Pfizer and Sinovac.

Vaccine makers can apply for approval with the country's regulators even if no clinical trial is done in the Philippines.

AUSTRALIA

It has agreed to buy 135 million doses: 34 million from AstraZeneca, 40 million from Novavax Inc, 10 million from Pfizer and 51 million from CSL Ltd.

It expects delivery of 3.8 million doses of AstraZeneca's vaccine in January and February next year.

CHINA

China has not announced supply deals with Western drugmakers, which instead have partnered with private companies.

AstraZeneca's vaccine may be approved in China by mid-2021 and its Chinese partner Shenzhen Kangtai Biological Products plans to have annual production capacity of at least 100 million doses of the vaccine by end-2020.

For the Pfizer/BioNTech vaccine, a unit of Shanghai Fosun Pharmaceutical Group plans a Phase 2 trial.

Tibet Rhodiola Pharmaceutical Holding is bringing in Russian vaccine candidate Sputnik V and plans early and mid-stage trials of the shot in China.

China has also approved three vaccine candidates developed by Sinovac and state-owned Sinopharm for emergency use programme, and Sinopharm is hopeful of its two candidates receiving conditional approval for general public use within this year.

JAPAN

Japan has deals to purchase 120 million doses from Pfizer/BioNTech in the first half of next year, 120 million from AstraZeneca, of which first 30 million will be shipped by March 2021, and 250 million from Novavax.

It is also in talks with Johnson & Johnson and has a deal with Shionogi & Co.

Experts said vaccine makers would need to conduct at least Phase 1-2 trials in Japan before seeking approval.

SOUTH KOREA

It aims to secure vaccines for 10 million people from COVAX and 20 million people from separate deals with drugmakers by the end of this year.

It has the "Optional Purchase" arrangement with COVAX that allows it to select vaccines from specific vaccine makers.

The timing of the procurement and the amount depend on the production schedule of those vaccines, according to health officials.

Inoculation is likely to start in the second quarter of next year to allow more time to observe potential side effects.

INDIA

The head of the Serum Institute of India, which makes the AstraZeneca vaccine, said on Nov 23 the positive late-state trial result of the candidate will allow it to seek emergency use authorisation by year-end, before gaining approval for a full rollout by February or March next year.

India also expects a government-backed vaccine to be launched as early as February, while it is conducting a late-stage trial of Sputnik V.

TAIWAN

Taiwan aims to secure around 15 million doses initially, both via the COVAX scheme and by directly purchasing from vaccine makers, and may buy additional 15 million doses.

The government has said it hopes to begin vaccinations in the first quarter of next year.

INDONESIA

It is one of the countries listed as 92 low and middle income economies, which means it is entitled to have access to vaccines through COVAX for 20% of its population, or approximately 106-107 million doses if each person gets two injections.

Indonesia is testing Sinovac vaccine and preparing to start mass vaccination for medical staff and other frontline workers as early as late January.

VIETNAM

A government official says vaccines from COVAX would cover only 20% of its population and the country is likely to have a chance to secure separate deals soon as overall demand is very high.

BANGLADESH

Bangladesh signed a deal with India's Serum to buy 30 million doses of the AstraZeneca vaccine.

It also expects to receive 68 million doses from GAVI at a subsidized rate, a senior health ministry official said.

-reuters-

Pfizer-BioNTech vaccine deliveries could start 'before Christmas'

* Pfizer says shot efficacy consistent across age, ethnic groups

* Efficacy in vulnerable over-65s was over 94%, drugmaker says

* A mass rollout to take months, complicated by cold storage

Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.

The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," he said.

The success rate of the vaccine developed by the U.S. drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.

Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique," said Enrico Bucci, a biologist at Temple University in Philadelphia. "Today is a special day."

BioNTech's Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday.

An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine showing 94.5% effectiveness.

"We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks," U.S. Health and Human Services Secretary Alex Azar said.

The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group.

"This is the evidence we needed to ensure that the most vulnerable people are protected," said Andrew Hill, senior visiting research fellow at the University of Liverpool's department of pharmacology.

Global shares rose as the trial results countered concerns around the soaring infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. Moderna shares fell 3.6%.

Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.

DISTRIBUTING SHOTS

Pfizer said it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations, it will be months before large-scale rollouts begin in either country.

On Wednesday, Pfizer said it had offered to provide Brazil with millions of doses in the first half of 2021. It also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Mike Ryan, the World Health Organization's top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box.

Moderna's vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F).

FATIGUE AND HEADACHES

Pfizer said vaccine was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headaches (2%) after the second dose. Older adults tended to report fewer and milder adverse events.

"These are extraordinary results, and the safety data look good," said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

Of the dozens of drugmakers and research groups racing to develop COVID-19 vaccines, the next late-stage data will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson said it is on track to deliver data this year.

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under age 18 and as young as 12. Moderna and J&J have said they hope to start testing the vaccine in younger people soon.

(Reporting by Michael Erman in Maplewood, N.J.; Additional reporting by Ankur Banerjee in Bengaluru, Caroline Humer and Carl O'Donnell in New York, Dan Levine in San Francisco, Elizabeth Howcroft, Kate Kelland and Josephine Mason in London, Emilio Parodi in Milan and Stephanie Nebehay in Geneva; Writing by David Clarke and Bill Berkrot; Editing by Pravin Char and David Gregorio)

-reuters-

Moderna closes in on release of COVID-19 vaccine data

BENGALURU/NEW JERSEY - Moderna Inc said on Wednesday it has enough data for a first interim analysis of the late-stage trial of its experimental COVID-19 vaccine, which should help determine the vaccine's efficacy.

Moderna said the information is being prepared for submission to the trial's independent data safety monitoring board, which will look at the results and make a recommendation. It did not say when it plans to release the efficacy data.

The company said in a news release that it has seen a significant increase in the number of COVID-19 cases among trial participants as infection rates have surged around the United States.

Due to the spike in cases, the analysis will cover substantially more than 53 infections, which had been the targeted trigger point for the first analysis.

The company said the trial remains blinded, so neither it nor study investigators know which participants received the vaccine or a placebo. The vaccine will be deemed a success if the overwhelming majority of those infected had received a placebo, once the monitoring board looks at the early results.

Earlier in the day, Dr. Anthony Fauci, the top U.S. infectious disease expert, said Moderna could have the data from anywhere between "a couple of days" to "a little more than a week."

A high degree of effectiveness would make sense as it is "almost identical" to Pfizer Inc's experimental vaccine, Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said at a conference organized by the Financial Times.

"It may not be 95 percent, it might be 90 percent, or 96 percent, or 89 percent, but it is going to be up there," he said.

Pfizer on Monday said its COVID-19 vaccine was more than 90 percent effective based on interim trial results, significantly higher than the at least 50% efficacy regulators are looking for.

Moderna, which uses a similar messenger RNA technology as Pfizer, said earlier on Wednesday that its November timeline for initial data was on track.

It did not respond to a Reuters request for comment on when it would disclose the data.

The company would still have to wait for two-month follow-up safety data required by the U.S. Food and Drug Administration, which it expects to have in the second half of this month, before applying for U.S. emergency use authorization.

There are no vaccines that have gained global approval yet, although a handful, including Moderna's, are in late-stage studies.

Moderna's shares closed up 8.4 percent at $82.44 and rose to $83.85 in extended trading.

-reuters-

Planes, dry ice, pharmacies: Logistical challenges of COVID-19 vaccines

WASHINGTON - The United States could be the first country to launch one of the most ambitious vaccine operations in history: distributing and administering up to 600 million doses of a COVID-19 vaccine in just a few months.

Massive vaccine campaigns are nothing new -- they have been carried out for decades in the fight against the measles and flu, for example. 

But stamping out the coronavirus is a distinctly new challenge due to three factors: the short time frame for inoculating a huge number of people, the fact that most vaccines will require two doses, and the very low temperature at which some of the vaccines must be stored.

The vaccine developed by US pharmaceutical giant Pfizer and Germany's BioNTech, on track to be the first authorized for use in the United States, must be stored at -94 degrees Fahrenheit (-70 degrees Celsius), whereas the flu vaccine can be kept in a normal refrigerator.

Pfizer vaccines distributed in the US will come from its largest manufacturing plant located in Kalamazoo, Michigan. Their ship-out will include a precise, clockwork-like dance of containers, trucks and planes.

Thermal shipping containers will each be filled with dry ice and 975 vials of the vaccine which each contain five doses, for a total of 4,875 doses.

Every day six trucks will take the doses to air carriers such as FedEx, UPS or DHL, which will deliver them across the United States in one to two days and across the globe in three, Pfizer told AFP. 

The company expects an average of 20 daily cargo flights worldwide.

FedEx had to obtain special permission from civil aviation authorities to transport so much dry ice, which could pose a danger to the crew should it accidentally undergo "sublimation" and pass from a solid to a gas, the company told AFP.

Once the boxes have reached their final destination, they can be opened only briefly just two times a day.

"To run a large mass vaccination clinic, it's fine," said Julie Swann, a pandemic response expert at North Carolina State University.

But the vaccine would not be suitable for distribution at doctors' offices or pharmacies, which are too small, she warned.

At least in the beginning Americans will have to go to hospitals or maybe even large distribution centers set up in parking lots much like COVID test sites, she said.

The vaccines can remain in their boxes for two weeks meaning hospitals will not need a special freezer.

"We're not recommending at this time that hospitals or clinics purchase ultra cold equipment," said Janell Routh of the Centers for Disease Control and Prevention.

POOR COUNTRIES LATER

US biotech giant Moderna is also manufacturing a vaccine, which can be stored at -4 degrees Fahrenheit, the temperature of a normal freezer.

The US government is organizing a free distribution of this vaccine to US states and territories, with each jurisdiction to decide how to distribute the doses to hospitals, pharmacies, doctors or even universities and companies will distribute the doses, in a decentralized system much like what was used for the H1N1 flu pandemic in 2009.

"The federal government does not intend, with very, very few exceptions, to touch a single dose of vaccine before it goes into the arm of Americans," said Paul Mango, an Operation Warp Speed official, during a briefing.

The objective is to offer vaccines to the most vulnerable populations before the end of December, to healthcare workers before the end of January and all Americans by the beginning of April.

Pfizer expects to produce 50 million doses this year and 1.3 billion in 2021: The United States has already ordered 100 million total including 20-30 million for delivery before the end of December. The European Union meanwhile has ordered 200 million, Japan 120 million, Britain 30 million and Canada 20 million.

Moderna, AstraZeneca, Johnson & Johnson, Sanofi and others are hoping their own vaccines will also prove safe and effective, and their global rollout will follow suit.

Carrier DHL estimates that 15 million cooling boxes would need to be delivered over the next two years, with approximately 15,000 flights needed worldwide.

Poorer countries that lack storage capacity for large quantities of vaccines that need super-cold storage have little hope of benefiting from the first doses, said Prashant Yadav, an expert in global health supply chains at the Center for Global Development.

Ultracold freezers that can reach temperatures of -112 degrees Fahrenheit cost five times more than standard freezers and are only made to order, he said.

Agence France-Presse