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

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-

US floats idea of early approval for eventual vaccine

WASHINGTON - The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness. 

A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times. 

"If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination.”

But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.

"This is going to be a science, medicine, data decision," Hahn said. "This is not going to be a political decision."

Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.

The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance.

By the nature of the trials it is difficult to predict when reliable results will emerge.

Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo. 

Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically significant difference in the infection rate of the two groups.

As the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials -- drawing criticism from public health officials in other countries, including the US.

Hahn also said that an emergency authorization would not necessarily cover everyone -- it might be granted for specific, high-risk groups.

"Our emergency use authorization is not the same as a full approval," he said.

Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents.

In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.

More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.

"It is f-ing outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA's subservience to Trump," Eric Topol, director of the Scripps Research Translational Institute, said on Twitter.

"We will not know about safety for many months."

Agence France-Presse

Pfizer begins human trials of possible coronavirus vaccine

Pfizer and the German pharmaceutical company BioNTech announced that their potential coronavirus vaccine began human trials in the United States on Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September.

The two firms are jointly developing a vaccine candidate based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, the vaccine could potentially tell cells how to make the spike protein of the coronavirus without actually making a person sick.

Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection. The technology also has the advantage of being faster to produce, and tends to be more stable than traditional vaccines, which use weakened virus strains.

Moderna, Inovio, CanSino and several other pharmaceutical companies are trying similar approaches, some of which began the first phase of tests in humans a few weeks ago. But no vaccine made with this technology for other viruses has ever reached the global market.

Pfizer, which is based in New York, and BioNTech injected the first human volunteers with their vaccine candidate, called BNT162, in Germany last month. The experimental shot was given to just 12 healthy adults, although the trial will eventually expand to 200 participants.

In the United States, the drug companies plan to test the vaccine on 360 healthy volunteers for the first stage of the study, adding up to 8,000 volunteers by the end of the second stage. The study will be conducted at New York University’s Grossman School of Medicine, the University of Maryland School of Medicine, the University of Rochester Medical Center and the Cincinnati Children’s Hospital Medical Center.

Participants will be divided into groups to compare four variations of the vaccine, each representing a format of messenger RNA with instructions to make a distinct piece of the spike protein machinery. Doctors will closely monitor the participants’ antibody levels, liver enzymes and other indicators of possible side effects.

“Vaccines are given to healthy people to keep them healthy, so they have to be very, very safe,” said Dr. Mark Mulligan, an infectious disease specialist at NYU.

Testing multiple candidates in parallel is one way the companies hope to compress the amount of time it takes to gather enough proof to apply for emergency-use approval by the Food and Drug Administration. Once that approval is received, Pfizer and BioNTech could distribute the first few million doses here.

As soon as pharmaceutical companies can show evidence that a vaccine is effective and has produced no serious harms, they can apply for this kind of approval, which allows doctors to administer the vaccine to those most in need. But more detailed study results may still be needed to persuade federal regulators to approve a candidate for the broader public.

Given the need to quash the coronavirus, vaccine-makers around the world are racing to speed up their timelines for development, a process that typically takes years. But companies are making extraordinary efforts to stagger trials and, in some cases, skip essential steps, such as animal testing.

Some experts have warned that expecting an approved vaccine within 18 months — as Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, has suggested — is overly optimistic.

A group of scientists developing a vaccine at Oxford University in England say that even 18 months is too long to wait for a vaccine. With emergency approval, they say they are aiming to have the first few million doses of their vaccine available in September.

Pfizer and BioNTech say they hope to have several million doses by then, too, if everything goes well with these human trials.

“We need to think differently, we need to think faster,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer. “If we get hit with a second wave of coronavirus infections in October at the same time as the flu, things will be much worse than what we’ve already experienced.”

-The New York Times-