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-

US plant ruins 15 million J&J coronavirus vaccine doses: report

WASHINGTON - About 15 million doses of the single-shot coronavirus vaccine made by Johnson & Johnson were ruined in a factory error in the United States, The New York Times reported -- a blow to the company's efforts to quickly boost production.

When contacted by AFP, the pharmaceutical giant said it had identified a batch of doses at a plant in Baltimore run by Emergent BioSolutions "that did not meet quality standards" but did not confirm the specific number affected. 

The company also said the batch "was never advanced to the filling and finishing stages of our manufacturing process." 

"Quality and safety continue to be our top priority," it said.

The Times report however signaled that issues with quality control could affect future output, with the Food and Drug Administration expected to investigate. 

The FDA told AFP it was "aware of the situation" but declined to comment further.

Johnson & Johnson said it was sending more experts to the site to "supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine," which would allow it to deliver an additional 24 million shots "through April."

The Emergent BioSolutions plant had not yet been authorized by US regulators to manufacture a "drug substance" for the J&J vaccine, the company said, but US media reported that it was expected to produce tens of millions of doses in the near future.

The J&J vaccine has won praise for its single dosage and because it does not need to be frozen -- unlike the shots from Moderna and Pfizer -- making distribution much simpler. 

"We continue to expect to deliver our Covid-19 vaccine at a rate of more than one billion doses by the end of 2021," J&J said.

Agence France-Presse

Afghanistan begins COVID-19 vaccination drive amid rising violence

KABUL - Afghanistan began its first COVID-19 vaccinations on Tuesday, administering doses initially to security force members, health workers and journalists, in a campaign that may face challenges from a sharp rise in violence.

The war-damaged country received 500,000 doses of AstraZeneca's vaccine from the Serum Institute of India (SII), which is producing the vaccine for mid- and low-income countries, earlier this month.

In a ceremony at the presidential palace, acting health minister Waheed Majroh said the vaccines would be provided to 250,000 people, mostly from the security, health, education and media sectors.

"Today is a fortunate day for Afghanistan as we launch the first vaccination drive, but it would be a challenge to roll the plan to the whole country," Majroh said.

Taliban insurgents fighting the foreign-backed Afghan government have announced their backing for the vaccination campaign.

However, the inoculations will take place amid relentless violence despite the government and the Taliban insurgents opening peace talks in September. The discussions have produced no progress to date.

A report by the United nations released on Tuesday said civilian casualties escalated sharply after peace talks begin last year and it called for a ceasefire.

Afghan health officials have said that the international COVAX program, which is aimed at improving access to the COVID-19 vaccine for developing countries, would provide vaccines to cover 20 percent of the country's 38 million population. 

President Ashraf Ghani, one of several Afghan leaders who witnessed the first injections, said the pandemic is still a serious problem for the country and called on health workers to vaccinate people in a fair and transparent manner.

He added efforts are under way to cover 40 percent of the population in a second round.

Afghanistan has registered 55,646 infections and 2,435 deaths. But experts say cases are significantly under-reported due to low testing and limited access to medical facilities in the war-torn country. 

-reuters-

Mexican billionaire Carlos Slim has COVID-19

MEXICO CITY - Mexican telecoms billionaire Carlos Slim, one of the world's richest men, is being treated for Covid-19 but has only mild symptoms, the 80-year-old mogul's family said Monday.

"He's very well. He is making very good progress with Covid-19 after more than a week of minor symptoms," the tycoon's son, Carlos Slim Domit, said on Twitter.

Slim and his family, who control mobile telecom giant America Movil, are worth an estimated $59.9 billion, according to Forbes magazine, making him Latin America's richest man.

Through his foundation, he is helping to fund joint production in Mexico and Argentina of the coronavirus vaccine developed by AstraZeneca and the University of Oxford for distribution in Latin America.

The announcement by his family came a day after Mexican President Andres Manuel Lopez Obrador said that he, too, was infected with the novel coronavirus but had only mild symptoms.

Mexico has officially registered more than 1.7 million Covid-19 cases and nearly 150,000 deaths -- the world's fourth-highest fatality toll after the United States, Brazil and India.

Agence France-Presse

Sinovac secures $515-M funding to boost COVID-19 vaccine production

SHANGHAI - China's Sinovac Biotech has secured $515 million in funding from a local firm to double production capacity of its coronavirus vaccine, the companies said on Monday, as it expects efficacy data of its experimental shot this month.

The investment deal also comes as Sinovac expands supply deals and trials of its experimental COVID-19 vaccine CoronaVac with more countries following positive results from early to mid-stage clinical trials.

China's Sino Biopharmaceutical Limited said on Monday a business unit will invest $515 million in Sinovac Life Sciences, a subsidiary of Sinovac, to help development and production of CoronaVac.

The investment will give Sino Biopharmaceutical a 15.03 percent interest in Sinovac Life Sciences, Sino Biopharmaceutical said in a filing to the Hong Kong Stock Exchange.

Sinovac said in a separate statement that it would be able to manufacture 300 million vaccine doses annually and aims to complete construction of a second production facility by the end of 2020 to increase annual COVID-19 vaccine production capacity to 600 million doses.

Depending on market conditions and the availability of financing, it may seek to further expand its production capacity, Sinovac said.

Sinovac has secured CoronaVac supply deals with several countries including Indonesia, Turkey, Brazil and Chile, and is holding talks with the Philippines for a potential sale. 

CoronaVac is also one of three experimental COVID-19 vaccines China has been using to inoculate around 1 million people under an emergency use programme. 

Brazil's Butantan Institute biomedical centre, which is running a Phase 3 trial of CoronaVac in the country, said last week that Sinovac was expected to publish efficacy results from its vaccine trials by Dec. 15.

-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-

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-

Venezuela's Maduro says son to join virus vaccine trial

CARACAS - Venezuelan President Nicolas Maduro said Sunday his son will join trials of Sputnik V, the coronavirus vaccine which was met with caution when Russia announced it was the world's first to be approved.

An initial batch of the vaccine arrived in Venezuela on Friday, the government announced, and 2,000 residents will participate in the trials.

"In this clinical trial phase, my son, Nicolas Ernesto Maduro Guerra, told me of his decision to be vaccinated with the Russian vaccine, to join the trial. I think it is very good," the socialist leader said in a speech on state television network VTV.

Maduro's sister is also a volunteer for the clinical trials.

Maduro Guerra, 30, is also a politician and a member of his father's governing United Socialist Party of Venezuela (PSUV).

Named "Sputnik V" after the historic Soviet-era satellite, the vaccine was met with skepticism from the global medical community.

Russia in August declared itself the first country to approve a coronavirus vaccine, although it is still undergoing large-scale clinical trials after promising results.

The drug is currently in Phase 3, the human testing state, and according to Moscow, more than 40,000 volunteers have been inoculated during the process.

"When the entire scientific, clinical and testing phase is closed, voluntary vaccination will come... As soon as we start mass vaccination, I am going to be the first one to get it," Maduro said.

Russia has been one of Maduro's main backers in the face of international pressure led by Washington, which seeks to displace him from power because it considers his reelection to have been fraudulent.

The US, as well as some 50 other countries, recognize Maduro's opponent, National Assembly speaker Juan Guaido, as Venezuela's interim president.

Guaido slammed the decision to participate in the Russian trials, saying, "They use our people as guinea pigs."

According to official figures, as of Saturday, Venezuela has registered 77,646 cases of Covid-19 out of the entire 30 million population, and 649 deaths. These numbers are disputed by the country's opposition and international organizations such as Human Rights Watch.

Agence France-Presse

Vaccine still possible this year, despite trial pause: AstraZeneca

LONDON - Drugs giant AstraZeneca on Thursday said a COVID-19 vaccine could still be available by as early as the end of the year, despite a randomized clinical trial being paused.

"We could still have a vaccine by the end of this year, early next year," the UK-based company's chief executive Pascal Soriot said in comments at a media event.

AstraZeneca announced Wednesday it had "voluntarily paused" its trial of a drug developed alongside Oxford University after a UK volunteer developed an unexplained illness.

An independent committee was drafted in to review safety but the company said it was a "routine action" designed to maintain the integrity of the trials.

"We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity," Soriot said in a statement.

AstraZeneca's vaccine candidate is one of nine around the world currently in late-stage Phase 3 human trials.

In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31, and smaller groups are being tested in Brazil and elsewhere in South America.

The vaccine, called AZD1222, uses a weakened version of a common cold-causing adenovirus engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.

The director of UK scientific research charity the Wellcome Trust, Jeremy Farrar, said there were often pauses in vaccine trials.

He told BBC radio in an interview that it demonstrated the importance of conducting vaccine trials properly, with independent oversight and the involvement of the regulator.

"In the end, the public must have absolute trust that these vaccines are safe and of course effective, and in the end will hopefully bring the pandemic to a close," he added.

Britain's chief scientific adviser, Patrick Vallance, on Wednesday said similar events should be expected but progress on vaccines and therapeutics was positive overall.

"Some will read out this year in terms of efficacy and safety," he told a Downing Street news conference.

"And I think there's a reasonable chance that... we can think about the possibility of vaccination next year sometime at larger levels."

UK Health Secretary Matt Hancock said the pause was "not necessarily" a set-back, and said a similar pause occurred recently but was "resolved without a problem".

Agence France-Presse

COVID-19 vaccine frontrunner pauses trial after unexplained illness

WASHINGTON -- Pharmaceutical company AstraZeneca said Tuesday it had "voluntarily paused" a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.

The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a COVID-19 vaccine. 

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

It added that in large trials, illnesses will sometimes happen by chance but must be reviewed independently.

"We are working to expedite the review of the single event to minimize any potential impact on the trial timeline," the spokesperson added.

It was not immediately clear where the patient was, or the nature and severity of their illness.

Holds during clinical trials are not uncommon, but this is thought to be the first time it has happened for a COVID-19 vaccine trial.

AstraZeneca is one of 9 companies currently in late-stage Phase 3 trials for their vaccine candidates.

In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31. 

The vaccine, called AZD1222, uses a weakened version of a common cold causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.

Agence France-Presse 

Russia vaccine 'passes early trial test'

LONDON - Patients involved in early tests of a Russian coronavirus vaccine developed antibodies with "no serious adverse events", according to research published in The Lancet Friday, but experts said the trials were too small to prove safety and effectiveness.

Russia announced last month that its vaccine, named "Sputnik V" after the Soviet-era satellite that was the first launched into space in 1957, had already received approval. 

This raised concerns among Western scientists over a lack of safety data, with some warning that moving too quickly on a vaccine could be dangerous. 

Russia denounced criticism as an attempt to undermine Moscow's research.

In the Lancet study, Russian researchers reported on two small trials, each involving 38 healthy adults aged between 18 and 60, who were given a two-part immunization. 

Each participant was given a dose of the first part of the vaccine and then given a booster with the second part 21 days later. 

They were monitored over 42 days and all developed antibodies within the first three weeks. 

The report said the data showed that the vaccine was "safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers". 

The trials were open-label and not randomized, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomly assigned to different treatment groups. 

Researchers underlined that larger and longer trials -- including a placebo comparison -- would be needed to establish the long-term safety and effectiveness of the vaccine for preventing Covid-19 infection.

The report said the 76 participants of these trials would be monitored up to 180 days, adding that a more rigorous phase 3 clinical trial was planned with the involvement of 40,000 volunteers "from different age and risk groups". 

'SAFETY IS PARAMOUNT'

Naor Bar-Zeev of Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the research was "encouraging but small", adding that it did not give any data on effectiveness among older age groups, who are particularly vulnerable to COVID-19. 

"Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly," he said in a commentary in the Lancet. 

"Since vaccines are given to healthy people and, during the COVID-19 pandemic, potentially to everyone after approval following phase 3 trials, safety is paramount."

The pandemic has seen an unprecedented mobilization of funding and research to rush through a vaccine that can protect billions of people worldwide.

This week the US urged states to get ready for a potential COVID-19 vaccine rollout two days before the presidential election in November, sparking concerns President Donald Trump's administration is accelerating research to fit a political timetable. 

Russia has said that industrial production of its version is expected from September.

President Vladimir Putin said in early August that the vaccine gave "sustainable immunity" and that one of his own daughters had been inoculated, even though Russia's health ministry said clinical trials were not yet complete.

The World Health Organization has urged Russia to follow established guidelines and go "through all the stages" necessary to develop a safe vaccine. 

Sputnik V was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defense ministry. 

It uses a cold-causing adenovirus, which is then modified and combined with a part of the new coronavirus, SARS-CoV-2.

The report's lead author, Denis Logunov of Gamaleya, said the adenovirus vaccine enters people's cells and delivers the SARS-CoV-2 spike protein genetic code, helping the immune system "recognize and attack" the virus. 

Agence France-Presse

Russia produces first batch of virus vaccine, says ministry

Russia said Saturday that it has produced the first batch of its coronavirus vaccine, after President Vladimir Putin announced it had been first in the world to approve a vaccine.

Putin's announcement on Tuesday about the vaccine was met with caution from scientists and the World Health Organization who said it still needed a rigorous safety review.

"The first batch of the novel coronavirus vaccine developed by the Gamaleya research institute has been produced," the health ministry said in a statement quoted by Russian news agencies.

Putin said the vaccine was safe and that one of his own daughters had been inoculated, though clinical trials were not yet complete and final stage testing involving more than 2,000 people only started this week.

Western scientists were skeptical, with some warning that moving too quickly on a vaccine could be dangerous, but Russia denounced criticism as an attempt to undermine Moscow's research.

The Russian vaccine is called "Sputnik V" after the Soviet-era satellite that was the first launched into space in 1957.

It was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defense ministry.

The head of the institute, Alexander Gintsburg, told the TASS state news agency on Saturday that volunteers taking part in the final stage testing of the vaccine's safety and efficacy would have two inoculations.

Russia has said that industrial production is expected from September and that it plans to manufacture 5 million doses per month by December or January.

Health Minister Mikhail Murashko said this week that the vaccine would first be made available to medics and would later be available to all Russians on a voluntary basis.

With more than 917,000 confirmed infections, Russia's coronavirus caseload is currently fourth in the world after the United States, Brazil and India.

Currently Russia has 92,000 people hospitalized with the virus and 2,900 in intensive care, according to the health ministry.

Agence France-Presse

Pentagon awards Glaxo $342 million contract for COVID vaccines

WASHINGTON - The Pentagon on Thursday announced a $342 million contract has been awarded to British pharmaceutical giant GlaxoSmithKline to deliver "mass quantities of COVID-19 vaccines" to US troops.

It said GSK was the only company to make a bid for the contract, which will consist of supporting "military locations and personnel throughout the continental US and outside the continental US."

The work will be carried out in North Carolina "with an estimated completion date of Feb. 28, 2021," the Pentagon said.

The US Army will supervise execution of the project.

Agence France-Presse

Johnson & Johnson’s coronavirus vaccine protects monkeys, study finds

An experimental coronavirus vaccine developed by Johnson & Johnson protected monkeys from infection in a new study. It is the second vaccine candidate to show promising results in monkeys this week.

The company recently began a clinical trial in Europe and the United States to test its vaccine in people. It is one of more than 30 human trials for coronavirus vaccines underway across the world. But until these trials are complete — which will probably take several months — the monkey data offers the best clues to whether the vaccines will work.

“This week has been good — now we have two vaccines that work in monkeys,” said Angela Rasmussen, a virologist at Columbia University who was not involved in the studies. “It’s nice to be upbeat for a change.”

But she cautioned that the new results shouldn’t be used to rush large-scale trials in humans. “We just can’t take shortcuts,” she said.

Unlike many other vaccines in development that might require two injections, the Johnson & Johnson candidate shielded the monkeys with just one dose, according to a study published on Thursday in Nature.

“It’s a very reassuring level of protection we saw,” said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston and a co-author of the new study.

The study comes just two days after a similar one was published on a vaccine tested by Moderna and the National Institutes of Health.

But the two vaccines work in very different ways.

The Moderna vaccine delivers a kind of genetic material called “messenger RNA” into cells.

The cells use the vaccine RNA to produce a protein found on the surface of the coronavirus, called spike protein, which then hopefully prompts an immune response.

RNA-based vaccines are being tested for a number of diseases, but none have yet been licensed for use in people.

In the Moderna study, researchers vaccinated monkeys by giving them two shots spaced over four weeks. A month later, they infected the animals with the coronavirus. In some of the vaccinated monkeys, researchers could not detect the virus in the nose or lungs. In others, the virus replicated slowly before disappearing.

Moderna began Phase 3 trials of its mRNA vaccine on Monday, as did Pfizer, which is testing its own mRNA vaccine.

The Johnson & Johnson vaccine, in contrast, is based on a virus called Ad26, which researchers have modified so that it carries the coronavirus spike protein gene. The Ad26 virus can slip into human cells, but cannot replicate once inside them. Its host cell then uses the spike gene to make the coronavirus proteins.

This month, European regulators approved Johnson & Johnson’s Ad26 vaccine for Ebola. It was the first time this kind of virus-assisted gene delivery was approved for any disease.

In March, Barouch and his colleagues designed seven variants of an Ad26 vaccine for the coronavirus. They made tiny changes to the spike gene to see whether they could get cells to make more copies of the viral protein. They also tested variants that would make the spike protein more stable, which might prompt a stronger immune response.

Based on earlier research, Barouch and his colleagues suspected that the Ad26 vaccine would be very potent. They decided to run their experiment using just one dose, to see whether that was enough to provide immunity.

After a single injection of the vaccine, they waited six weeks and then infected the animals with the coronavirus. Six of the seven vaccine variants offered monkeys partial protection against the coronavirus, meaning that the virus replicated only at low levels in the animals.

The seventh version proved more powerful than the rest: Five out of six monkeys that received it had no detectable viruses at all. The sixth had only low levels in its nose.

“The fact that we could protect with a single shot in animal models was quite a positive surprise to us,” said Dr. Paul Stoffels, the chief scientific officer of Johnson & Johnson.

It was this best-performing vaccine that Johnson & Johnson used last week to begin its first human safety trial, a so-called Phase 1 trial. If it goes well, the company hopes by September to enter Phase 3 trials, which test not only whether the vaccine is safe, but also whether it works.

The company plans on testing both single and double doses. Rasmussen said that a vaccine that proved effective with a single dose would make it far easier to treat the billions of people who need it. “Theoretically, you would need less of it, so you give it to more people more quickly,” she said.

AstraZeneca and the University of Oxford have developed a vaccine based on yet another type of modified virus, called ChAdOx1. In May, they posted promising results in monkeys, and now they are running Phase 3 trials in people. They may get results by October.

“It’s exciting to see the number of platforms that are showing promise for a vaccine,” said Stacey L. Schultz-Cherry, a virologist at St. Jude Children’s Research Hospital in Memphis, Tennessee, who was not involved in any of the trials.

-Carl Zimmer, The New York Times-

Moderna begins first US late-stage vaccine trial

The first large study of safety and effectiveness of a coronavirus vaccine in the United States began Monday morning, according to the National Institutes of Health and biotech company Moderna, which collaborated to develop the vaccine.

A volunteer in Savannah, Georgia, received the first shot at 6:45 a.m., Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a news briefing.

The study, a Phase 3 clinical trial, will enroll 30,000 healthy people at about 89 sites around the country this summer. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who will get the real vaccine.

Researchers will then monitor the subjects, looking for side effects. And their main goal will be to see if significantly fewer vaccinated people contract COVID-19, to determine whether the vaccine can prevent the illness. The study will also try to find out if the vaccine can avert severe cases of COVID and death; if it can block the infection entirely, based on lab tests; and if just one shot can prevent the illness.

Fauci estimated that the full enrollment of 30,000 people would be completed by the end of the summer and that results might be available by November. Findings might emerge even earlier, he said, but added that he doubted it. He said that the high rates of transmission in some parts of the country, though unfortunate, would help speed up the process of determining whether the vaccine works.

Overall, a total of 150 to 160 coronavirus infections in the study will be enough to determine whether the vaccine is acceptably effective — that is, if it protects 60 percent of those who receive it, Fauci said.

Ideally, he would like the figure to be higher, but he said 60 percent “would be a major, huge step at controlling this outbreak; we’ll take that amount.”

Dr. Francis Collins, director of the National Institutes of Health, said the US government was reaching out to groups hit hardest by COVID — older people, those with chronic diseases, Blacks, Latinx and Native Americans — to encourage them to participate in the study. He said that the pandemic had put health disparities into “sharp relief” and that extra efforts were needed to gain the trust of people in those groups who might be reluctant to sign up for a medical experiment.

Earlier tests of Moderna’s vaccine showed that it stimulated a strong immune response, with minor and transient side effects like sore arms, fatigue, achiness and fever. But exactly what type of immune response is needed to prevent the illness is not known, so Phase 3 studies are essential to determine whether a vaccine really works.

In a statement, Collins said, “Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people.” He said that despite the unprecedented speed in bringing this experimental vaccine to human testing, “the most stringent safety measures” were being maintained.

Moderna said in a statement that it would be able to deliver about 500 million doses a year and possibly up to 1 billion doses per year, starting in 2021. The Massachusetts-based company, which has received nearly $1 billion from the federal government to develop a coronavirus vaccine, has said it will not sell the vaccine at cost, but for profit.

Moderna has not said what it will charge.

“We will price it responsibly during the pandemic, to make sure it is broadly accessible,” a spokesman, Ray Jordan, said in an email. The company may change the price later, when the virus becomes endemic, “but that is not something we have settled at this time,” Jordan said.

Moderna shares were up 8% at $79 in midday trading Monday.

The company’s vaccine uses a synthetic version of genetic material from part of the coronavirus, encased in tiny particles made of fat that help it get into human cells. The genetic material, called messenger RNA, or mRNA, then prompts the cells to churn out a tiny piece of the virus, which the immune system sees as foreign and learns to recognize. If the person is later exposed to the real virus, the immune system will attack it.

Messenger RNA has not yet produced any approved vaccines, but other companies have also invested in the approach because of its potential to produce vaccine quickly. The government announced last week that it had reached a $1.95 billion deal to buy 100 million doses of an mRNA vaccine made by Pfizer, in partnership with German company BioNTech, by the year’s end. That vaccine is also expected to begin Phase 3 trials soon, and the government will buy it only if the trial proves it safe and effective. CureVac and Sanofi are also working on mRNA vaccines.

At the news briefing, Collins said that three more Phase 3 trials would be starting soon, each needing 30,000 patients. Those trials will involve vaccines made by Novavax, Johnson & Johnson and a collaboration of the University of Oxford and AstraZeneca. All three companies are part of the Trump administration’s Operation Warp Speed.

Adults interested in participating in the Moderna trial can visit coronaviruspreventionnetwork.org or clinicaltrials.gov and search identifier NCT04470427.

-The New York Times Company-

AstraZeneca targets year-end for COVID-19 vaccine

PARIS - A coronavirus vaccine being developed by the University of Oxford and AstraZeneca should be available globally "at cost price" by year-end, the firm's director-general said Tuesday.

"Our objective is to bring the vaccine to everybody, (and) equally to do so on a not-for-profit basis so we shall be providing the vaccine at cost price," Pascal Soriot told RTL radio.

"At cost price that will be about 2.5 euros ($2.8) per unit.

"We hope to be able to produce a vaccine by the end of the year... perhaps a little earlier if all goes well" on the back of phase three results expected in the autumn, Soriot added in an interview.

Early results of a closely watched Phase 1/2 trial published this week in The Lancet suggest the vaccine candidate is safe and induces an immune response.

US group Johnson & Johnson has also vowed to deliver a vaccine at "non-profit" pricing.

In contrast rivals Pfizer, Merck and Moderna confirmed Tuesday to US lawmakers they would not sell vaccine at cost.

Soriot said the vaccine had performed well in stage 1 and 2 trials suggesting it offered good tolerability without serious side effects.

Stage 3 trials will now be carried out on a wider sample before product can finally be rolled out.

"We are working hand in hand with the regulators, we exchange our data on a daily basis to enable very swift evaluation. We are carrying out clinical trials which allows us to gain time," said Soriot.

He added the group had begun to produce product in "a number of regions" so they would be ready to start delivering "if the clinical trials are positive."

A separate trial in Wuhan, China, where the disease first emerged late last year and involving more than 500 people, showed most had developed widespread antibody immune response. 

The race is on in labs across the world to win the race to produce a vaccine to deal with the world health crisis the world has seen in a century.

More than 200 candidate vaccines are being developed with 23 having progressed to clinical trials with human volunteers.

Agence France-Presse

Moderna vaccine induced antibodies in all trial participants: paper

WASHINGTON - An experimental COVID-19 vaccine that is being developed by US biotech firm Moderna induced antibody responses against the coronavirus in all 45 participants of a human trial, a paper published Tuesday showed.

Moderna had previously published "interim results" from its Phase 1 in the form of a press release on its website in May, which revealed the vaccine had generated immune responses in eight patients.

Though these were called "encouraging" by Anthony Fauci, the top US infectious diseases official, the full study had been eagerly awaited by the scientific community.

The company has since moved to the next stage of its trial, involving 600 people.

The new paper was published in the New England Journal of Medicine.

The 45 participants were split into three groups of 15 each to test doses of 25 micrograms, 100 micrograms and 250 micrograms.

They were given a second dose 28-days-later.

After the first round, antibody levels were found to be higher with higher level doses, and after the second round, participants had higher levels of antibodies than most patients who have COVID-19 and gone on to generate their own antibodies.

More than half the participants experienced mild or moderate side-effects, though these did not rise to the level where the trial would be called off. 


The side effects included fatigue, chills, headache, body ache, and pain at the injection site.

Three participants did not receive their second dose, including one in the 25 microgram group who developed a skin rash on both legs, and two (one in the 25 microgram group, one in 250 groups) who missed their window because they had COVID-19 symptoms, but their tests later returned negative.

Andrew Freedman, an infectious disease expert at the University of Cardiff who was not involved in the study, said the paper suggested the vaccine "is able to stimulate antibody production in a dose-dependent fashion."

"Importantly, the antibodies generated were able to neutralize the virus" in lab conditions, he added.

"The side effects experienced by more than half the participants are quite common after other vaccinations, although the 'more severe adverse events' experienced by three of the subjects given the highest dose may mean that dose is too high to take forward," he said.

The Moderna vaccine belongs to a new class of vaccine that uses genetic material, in the form of RNA, to encode the information needed to grow the virus' spike protein inside the human body, in order to trigger an immune response. 

The spike protein is a part of the virus it uses to invade human cells, but by itself is relatively harmless.

Agence France-Presse

Vaccine against COVID-19 not certain, maybe in a year: WHO

BRUSSELS - It is not certain that scientists will be able to create an effective vaccine against the coronavirus that has caused the COVID-19 pandemic, but it could take a year before one were to be invented, the head of the World Health Organization said.

Speaking by video-conference to deputies from the European Parliament's health committee, Tedros Adhanom Ghebreyesus said that if such a vaccine became a reality, it should become a public good available to all.

"It would be very difficult to say for sure that we will have a vaccine," Tedros said. "We never had a vaccine for a coronavirus. So this will be, when discovered, hoping that it will be discovered, it will be the first one," he said.

He said the WHO had already more than 100 candidates for a vaccine of which one was at an advanced stage of development.

"Hoping that there will be a vaccine, the estimate is we may have a vaccine within one year. If accelerated, it could be even less than that, but by a couple of months. That's what scientists are saying," he said.

-reuters-

Europe to accelerate trials of gene-engineered COVID-19 vaccines: sources

BRUSSELS - European officials aim to speed up trials for coronavirus vaccines containing genetically modified organisms, two EU sources told Reuters, in a move that could help shots developed by companies like AstraZeneca and Johnson & Johnson.

The European Commission is expected to put forward the plans as early as next week. They are part of a wider EU strategy aimed at securing enough doses of a possible vaccine for the bloc as it fears lagging behind the United States and China.

The reform is expected to reduce member states' power to impose extra requirements on drug companies when they conduct clinical trials on medicines and vaccines containing genetically modified organisms (GMOs), according to the sources.

In some countries like Italy and France, for example, treatments must receive authorization from government environment or research departments, as well as from health and drug authorities, under rules that are up to 20 years old and also cover the more publicly sensitive area of GMO crops.

This has long caused bottlenecks in a pharmaceutical industry that increasingly relies on genetic engineering.

Such delays could be particularly problematic now that Europe may quickly need to accelerate trials, an EU Commission official said, warning that some of the most promising COVID-19 shots under development contain GMOs.

A spokesman for the EU Commission, the EU executive, declined to comment.

Vaccines Europe, which represents many big pharmaceutical players including AstraZeneca, Sanofi, Pfizer , GSK and Novavax, said planned changes would create a level playing field between vaccines that contain GMOs and those that do not.

"GMOs are very specific to very few vaccines based on adenovirus vectors," Michel Stoffel of Vaccines Europe told Reuters, citing those developed by AstraZeneca and Johnson & Johnson among those that contain GMOs and would benefit from the possible changes.

Vaccines developed by Chinese firm Cansino and U.S. giant Merck also contain adenovirus vectors, which cause the common cold, and other replicating viruses. They aim to introduce a gene from the novel coronavirus into our bodies, to elicit an immune response and protect from subsequent exposure.

MASS TRIALS

The United States last week identified five companies as the most likely candidates to produce a vaccine for the coronavirus. They are: US players Johnson & Johnson, Moderna, Merck, Pfizer as well as Britain's AstraZeneca, which is working with Oxford university.

Promising candidate vaccines may soon reach the stage of mass trials involving thousands of volunteers in several countries. If the bloc does not speed up its authorization process for GMO vaccines to allow such trials to happen swiftly in Europe, the continent could fall behind in gaining access to any successful shots in bulk.

Any decision by the European Commission to accelerate GMO vaccine trials would need to be approved by EU lawmakers and member states.

The push by the bloc comes at a time when experts warn it is becoming increasingly difficult to trial vaccine candidates in Europe as the epidemic recedes there, because trials are usually most successful when a virus is widely circulating in the population.

A failure to come up with a vaccine would leave the region, and the world, exposed in the event of a second wave of infections.

The GMO vaccine plans are expected to be announced as part of an "EU strategy for the development of a COVID-19 vaccine", which the Commission will unveil on June 17, according to a draft agenda of the EU executive.

Officials have told Reuters that as part of the strategy, the Commission will also announce plans to use an emergency 2.4-billion-euro ($2.7 billion) fund to make advance purchases of promising vaccines against the new coronavirus.

The EU rainy-day fund, known as the Emergency Support Instrument (ESI), would also be used to increase vaccine production capacity in Europe and offer liability insurance to pharmaceutical companies, officials said.

-reuters-

Scientists hunt pandemic hotspots in race to test vaccines

* Low transmission rates may scupper fast vaccine trials

* Vaccine volunteers need to be put at risk of infection

* Drug developers search for pandemic hotspots at home and abroad

LONDON/CHICAGO - The first wave of the COVID-19 pandemic may be waning. For vaccine developers, that could be a problem.

Scientists in Europe and the United States say the relative success of draconian lockdown and social distancing policies in some areas and countries means virus transmission rates may be at such low levels that there is not enough disease circulating to truly test potential vaccines.


They may need to look further afield, to pandemic hotspots in Africa and Latin America, to get convincing results.

"Ironically, if we're really successful using public health measures to stamp out the hot spots of viral infection, it will be harder to test the vaccine," said Francis Collins, director of the National Institutes of Health in the United States.

A vaccine is seen as essential to ending a pandemic that has killed nearly 370,000 people and infected more than 6 million so far, with world leaders looking at inoculation as the only real way to restart their stalled economies.

But running large-scale clinical trials of potential vaccines against a completely new disease at speed is complex, scientists say. Showing efficacy in those trials during a fluctuating pandemic adds extra difficulty - and doing so when outbreaks are waning makes it harder still.

"For this to work, people need to have a risk of infection in the community. If the virus has been temporarily cleared out, then the exercise is futile," said Ayfer Ali, an expert in drug repurposing at Britain's Warwick Business School.

"The solution is to move to areas where the infection is being spread widely in the community – that would be countries like Brazil and Mexico at the moment."

Vaccine trials work by randomly dividing people into a treatment group and a control group, with the treatment group getting the experimental trial vaccine and the control group getting a placebo.

All participants go back into the community where the disease is circulating, and subsequent rates of infection are compared. The hope is that infections within the control group will be higher, showing the trial vaccine is protecting the other group.

With COVID-19 epidemics in Britain, mainland Europe and the United States coming down from their peak and transmission rates of the coronavirus dropping, a key task for scientists is to chase fluctuating outbreaks and seek volunteers in sections of populations or in countries where the disease is still rife.

A similar problem emerged when scientists were seeking to test potential new vaccines against Ebola during the vast 2014 outbreak in West Africa. Then, drugmakers were forced to drastically scale back plans for large trials because their vaccines were only test-ready late in the epidemic when case numbers were dwindling. 

LOOKING ABROAD

Among the first COVID-19 vaccines to move into phase two, or mid-stage, trials is one from the U.S. biotech company Moderna and another being developed by scientists at Oxford University supported by AstraZeneca. The United States in July is planning to launch vast efficacy trials of 20,000 to 30,000 volunteers per vaccine.

Collins said U.S. health officials will tap government and industry clinical trial networks in the United States first and use mapping to detect where the virus is most active. They will also consider looking abroad if domestic disease rates fall too far, he said.

The U.S. government has experience in Africa of testing vaccines against HIV, malaria and tuberculosis.

"Africa is now beginning to experience lots of cases of COVID-19. We might very well want to run part of the trial there, where we know we can collect the data effectively," said Collins.

Adrian Hill, director of the Jenner Institute at Britain's Oxford University which has teamed up with AstraZeneca, started mid-stage trials last month which he said would aim to recruit around 10,000 people in Britain.

AstraZeneca obtains $1 billion from US to help fund coronavirus vaccine
He told Reuters that with COVID-19 disease transmission rates dropping in the UK there is a possibility that the trial would have to be halted if they didn't have enough infections to yield a result.

"That would be disappointing, and at the moment it's unlikely, but it's certainly a possibility," Hill said.

CHALLENGE TRIALS

Underscoring the level of concern in the industry, AstraZeneca's chief executive Pascal Soriot said his researchers were even contemplating running so-called "challenge" trials - where participants would be given the experimental vaccine and then deliberately infected with COVID-19 to see if it worked. Such trials are rare, high risk and hard to get ethical approval for.

As a more practical and swifter option, Soriot and others are looking to Brazil and other countries in South America, as well as parts of Africa where COVID-19 outbreaks are still growing and peaking, as ripe drug and vaccine testing grounds.

Difficulty recruiting candidates for mid-stage vaccine trials in countries where the COVID-19 pandemic is on the wane may be foreshadowed by the experience of doctors seeking infected cases for the World Health Organization's multi-country Solidarity trial of potential treatments for the disease - including the generic drug hydroxychloroquine and Gilead's remdesivir.

In the Swiss portion of that trial, for instance, it took three weeks to get all of the ethical and regulatory approvals from authorities, and another week to get all the drugs, said Oriol Manuel, an infectious disease expert and national coordinator of the Solidarity study in Switzerland.

"We were able to enroll some patients in (one trial centre in) Lausanne," Manuel said. "But when all centres were ready, the cases were fortunately disappearing."

-reuters-