WASHINGTON (AP) — The U.S. will begin sharing its entire stock of AstraZeneca COVID-19 vaccines with the world once it clears federal safety reviews, the White House said Monday, with as many as 60 million doses expected to be available for export in the coming months.

The move greatly expands on the Biden administration’s action last month to share about 4 million doses of the vaccine with Mexico and Canada. The AstraZeneca vaccine is widely in use around the world but has not yet been authorized by the U.S. Food and Drug Administration.

The White House is increasingly feeling assured about the supply of the three vaccines being administered in the U.S., particularly following the restart of the single-dose Johnson & Johnson shot over the weekend. The U.S. has also been under mounting pressure in recent weeks to share more of its vaccine supply with the world, as countries like India experience devastating surges of the virus and others struggle to access doses needed to protect their most vulnerable populations.

“Given the strong portfolio of vaccines that the U.S. already has and that have been authorized by the FDA, and given that the AstraZeneca vaccine is not authorized for use in the U.S., we do not need to use the AstraZeneca vaccine here during the next several months,” said White House COVID-19 coordinator Jeff Zients. “Therefore the U.S. is looking at options to share the AstraZeneca doses with other countries as they become available.”

More than 3 million people worldwide have died of COVID-19, including more than 572,000 in the U.S. The U.S. has vaccinated more than 53% of its adult population with at least one dose of its three authorized vaccines from Pfizer, Moderna and J&J, and it expects to have enough supply for its entire population by early summer.

About 10 million doses of AstraZeneca vaccine have been produced but have yet to pass review by the FDA to “meet its expectations for product quality,” Zients said, noting the U.S. regulator is recognized as the “gold standard” for safety around the world. That process could be completed in the next several weeks. About 50 million more doses are in various stages of production and could be available to ship in May and June pending FDA sign-off.

The U.S. has yet to finalize where the AstraZeneca doses will go, Zients said. Neighbors Mexico and Canada have asked the Biden administration to share more doses, while dozens of other countries are looking to access supplies of the vaccine.

“We’re in the planning process at this point in time,” said White House press secretary Jen Psaki, when asked where the doses would go.

The AstraZeneca doses will be donated by the U.S. government, which has contracted with the company for a total of 300 million doses — though the company has faced production issues.

The administration’s move to share vaccines drew praise from nongovernmental aid groups, who encouraged the White House to develop plans to share even more doses.

“The Biden administration’s decision to begin sharing AstraZeneca vaccines is welcome news and an important first step towards the US sharing more of its massive vaccine stockpile,” said Tom Hart, acting CEO at The ONE Campaign. “The Biden administration should build on this welcome first step and start sharing more vaccines as soon as possible.”

In part because the AstraZeneca vaccine is not expected to play a significant factor in the U.S. virus response, the White House was also moving to share raw materials for the production of the AstraZeneca vaccine with India, which has emerged as a global hotspot for the virus, by diverting some of its orders to the vaccine manufacturer Serum Institute of India.

Zients told the AP that the Biden administration was working to satisfy other “key requests” from the Indian government, namely for personal protective equipment, tests, therapeutics and supplies of oxygen and respiratory assistance devices.

“The administration’s identified U.S. commercial suppliers of therapeutics that are immediately available to help relieve the suffering of the COVID-19 patients in India,” said Zients. “We’ve identified rapid diagnostic tests and supplies and PPE, and additional ventilators that are available to transferred to India.”

Epidemiologists from the Centers for Disease Control and Prevention were also expected to soon travel to India to assist the country with its virus response.

The additional quality review before the U.S. shares the AstraZeneca doses were in order because of issues at the facility that produced them, White House officials said.

AstraZeneca’s doses in the U.S. were produced at an Emergent BioSolutions plant in Baltimore that has come under increased regulatory and public scrutiny after botching batches of the J&J vaccine. The U.S. pressed J&J to take over the plant and, as part of the effort to ensure the quality of newly produced vaccines, directed the facility to stop making the AstraZeneca shot. AstraZeneca is still looking to identify a new U.S. production facility for its future doses.

The U.S. government ordered enough for 150 million Americans before issues with the vaccine’s clinical trial held up clearance. The company’s 30,000-person U.S. trial didn’t complete enrollment until January, and it still has not filed for an emergency-use authorization with the FDA.

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WASHINGTON (AP) — AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.

In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.

AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.

“I do hope it puts to bed any doubts about the vaccine efficacy,” Mene Pangalos, AstraZeneca’s biopharmaceuticals research chief, told The Associated Press. “Overall where the vaccine is being used, it’s been shown to be highly effective. So I hope that the U.S. study now will continue to give the vaccine some momentum and get it used even further around the world.”

The company aims to file an application with the Food and Drug Administration in the coming weeks, and the government’s outside advisers will publicly debate the evidence before the agency makes a decision. Pangalos said the vaccine could win emergency authorization toward the second half of April. If so, the company would deliver 30 million doses immediately and an additional 20 million within the first month.

What that will mean for America’s vaccination plans is unclear. The Biden administration already projects there will be enough doses for all adults by the end of May thanks to increasing supplies from the makers of the three vaccines already in use in the U.S. — Pfizer, Moderna and Johnson & Johnson.

Federal officials said they didn’t want to prejudge the FDA’s review but cast the AstraZeneca findings as a victory both for the U.S. supply and the global fight against the virus.

“There are very many countries in Europe and throughout the world who have already authorized this, so the fact that a United States-run study has confirmed the efficacy and the safety of this vaccine I think is an important contribution to global health in general,” said Dr. Anthony Fauci, the top U.S. infectious disease expert.

The AstraZeneca shot, which has been authorized in more than 70 countries, is a pillar of a U.N.-backed project known as COVAX that aims to get COVID-19 vaccines to poorer countries. It has also become a key tool in European countries’ efforts to boost their sluggish vaccine rollouts. That made doubts about the shots especially worrying.

Even before the blood clot scare, scientists hoped the U.S. study would clear up some confusion about how well the vaccine really works. While previous research suggested it was effective in younger populations, there were questions about how well it protects those over 65, often those most vulnerable to COVID-19.

Also, Britain authorized the vaccine based on partial results from testing in the United Kingdom, Brazil and South Africa that suggested the shots were about 70% effective. But those results were clouded by a manufacturing mistake that led some participants to get just a half dose in their first shot.

Stephen Evans, of the London School of Hygiene & Tropical Medicine, said the new data could help allay concerns.

“The benefits of these results will mainly be for the rest of the world where confidence in the AZ vaccine has been eroded, largely by political and media comment,” he said.

Two-thirds of the volunteers in the U.S. study received the vaccine and the rest dummy shots, and Monday’s report is based on the first 141 COVID-19 cases reported after the second vaccine dose kicked in. AstraZeneca declined to provide a breakdown of those cases, as it continues to prepare its FDA submission.

But Fauci said the study was careful to include different ages, racial and ethnic minorities, and people with underlying health conditions, and found “comparable efficacy across ethnicity and age.”

Dr. Paul Hunter, a professor of medicine at the University of East Anglia, said the results were reassuring but that more details are needed to back up AstraZeneca’s claims.

“But this should add confidence that the vaccine is doing what it is most needed for,” said Hunter, who was not connected to the study.

On the safety front, France, Germany, Italy and other countries have resumed their use of the AstraZeneca vaccine after the suspension last week to investigate clots. On Thursday, the European Medicines Agency concluded the vaccine did not raise the overall risk of clots, but could not rule out that it was connected to two very rare types.

In the U.S., as in Britain and Europe, major efforts already are underway to watch for any unexpected problems as the first vaccines are rolling out. And as the U.S. considers AstraZeneca’s vaccine, Fauci said, “You can rest assured that the FDA will put a great deal of scrutiny in every aspect of these data.”

The AstraZeneca shot is what scientists call a “viral vector” vaccine. The shots are made with a harmless cold virus that normally infects chimpanzees. It acts like a Trojan horse to carry genetic material from the coronavirus’s spike protein into the body. That primes the immune system to fight back if the real virus comes along.

Two other companies, Johnson & Johnson and China’s CanSino Biologics, make COVID-19 vaccines using the same technology but using different cold viruses.

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BERLIN (AP) — A cascading number of European countries — including Germany, France, Italy and Spain — suspended use of AstraZeneca’s COVID-19 vaccine Monday over reports of dangerous blood clots in some recipients, though the company and international regulators say there is no evidence the shot is to blame.

AstraZeneca’s formula is one of three vaccines in use on the continent. But the escalating concern is another setback for the European Union’s vaccination drive, which has been plagued by shortages and other hurdles and is lagging well behind the campaigns in Britain and the U.S.

The EU’s drug regulatory agency called a meeting for Thursday to review experts’ findings on the AstraZeneca shot and decide whether action needs to be taken.

The furor comes as much of Europe is tightening restrictions on schools and businesses amid surging cases of COVID-19.

Germany’s health minister said the decision to suspend AstraZeneca shots was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven cases of clots in the brains of people who had been vaccinated.

“Today’s decision is a purely precautionary measure,” Jens Spahn said.

French President Emmanuel Macron said his country will likewise stop dispensing the vaccine until at least Tuesday afternoon. Italy also announced a temporary ban, as did Spain, Portugal and Slovenia.

Other countries that have done so over the past few days include Denmark, which was the first, as well as Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria. Canada and Britain are standing by the vaccine for now.

In the coming weeks, AstraZeneca is expected to apply for U.S. authorization of its vaccine. The U.S. now relies on Pfizer’s, Moderna’s and Johnson & Johnson’s shots.

AstraZeneca said there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country EU and Britain. The drugmaker said there is no evidence the vaccine carries an increased risk of clots.

In fact, it said the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.

The World Health Organization and the EU’s European Medicines Agency have also said that the data does not suggest the vaccine caused the clots and that people should continue to be immunized.

“Many thousands of people develop blood clots annually in the EU for different reasons,” the European Medicines Agency said. The incidence in vaccinated people “seems not to be higher than that seen in the general population.”

The agency said that while the investigation is going on, “the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.”

Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 instances of pulmonary embolisms, or clots in the lungs.

The AstraZeneca shot has become a key tool in European countries’ efforts to boost their sluggish vaccine rollouts. It is also pillar of a U.N.-backed project known as COVAX that aims to supply COVID-19 vaccines to poorer countries. That program continues unaffected by the European suspension.

Pfizer’s and Moderna’s vaccines are also used on the European continent, and J&J’s one-shot vaccine has been authorized but not yet delivered.

Dr. Michael Head, a senior research fellow in global health at the University of Southampton in England, said there is no data yet to justify suspending the AstraZeneca vaccine and called the decision “baffling.”

“Halting a vaccine rollout during a pandemic has consequences,” Head said. “This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned.”

Spahn, the German health minister, defended the country’s decision, saying, “The most important thing for confidence is transparency.” He said both first and second doses would be suspended.

Germany has received slightly over 3 million doses of the AstraZeneca vaccine, and about half of those have so far been administered, compared with almost 7 million of the Pfizer shot and about 285,000 from Moderna.

German authorities have encouraged anyone who feels increasingly ill more than four days after receiving the shot — for example, with persistent headaches or dot-shaped bruises — to seek medical attention.

The head of the Spanish Medicines Agency, Maria Jesús Lamas, said Spain detected its first case of clots on Saturday. She said the ban was “not an easy decision” because it further slows the nation’s vaccination campaign, but it was the “most prudent” approach.

Almost 940,000 people in Spain have received the AstraZeneca shot.

Some European countries, meanwhile, have begun reimposing restrictions in a bid to beat back a resurgence in infections, many of them from variants of the original virus.

In Italy, 80% of children nationwide couldn’t attend classes after stricter rules in more regions took effect on Monday. In Poland, bolstered restrictions were applied to two more regions, including Warsaw. Paris could go into lockdown in a matter of days because intensive care units are getting swamped with COVID-19 patients.

And calls are growing in Germany to “ pull the emergency brake” in regions where cases are rising.

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LONDON (AP) — AstraZeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

A statement describing the error came days after the company and the university described the shots as “highly effective” and made no mention of why some study participants didn’t receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90% effective. In the group that got two full doses, the vaccine appeared to be 62% effective. Combined, the drugmakers said the vaccine appeared to be 70% effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.

The partial results announced Monday are from large ongoing studies in the U.K. and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.

DID RESEARCHERS MEAN TO GIVE A HALF DOSE?

Before they begin their research, scientists spell out all the steps they are taking, and how they will analyze the results. Any deviation from that protocol can put the results in question.

In a statement Wednesday, Oxford University said some of the vials used in the trial didn’t have the right concentration of vaccine so some volunteers got a half dose. The university said that it discussed the problem with regulators, and agreed to complete the late stage trial with two groups. The manufacturing problem has been corrected, according to the statement.

WHAT ABOUT THE RESULTS THEMSELVES?

Experts say the relatively small number of people in the low dose group makes it difficult to know if the effectiveness seen in the group is real or a statistical quirk. Some 2,741 people received a half dose of the vaccine followed by a full dose, AstraZeneca said. A total of 8,895 people received two full doses.

Another factor: none of the people in the low-dose group were over 55 years old. Younger people tend to mount a stronger immune response than older people, so it could be that the youth of the participants in the low-dose group is why it looked more effective, not the size of the dose.

Another point of confusion comes from a decision to pool results from two groups of participants who received different dosing levels to reach an average 70% effectiveness, said David Salisbury, and associate fellow of the global health program at the Chatham House think tank.

“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,″ he said of the figure. “I think many people are having trouble with that.″

WHY WOULD A SMALLER FIRST DOSE BE MORE EFFECTIVE?

Oxford researchers say they aren’t certain and they are working to uncover the reason.

Sarah Gilbert, one of the Oxford scientists leading the research, said the answer is probably related to providing exactly the right amount of vaccine to trigger the best immune response.

“It’s the Goldilocks amount that you want, I think, not too little and not too much. Too much could give you a poor quality response as well,’’ she said. “So you want just the right amount and it’s a bit hit and miss when you’re trying to go quickly to get that perfect first time.”

WHAT ARE THE NEXT STEPS?

Details of the trial results will be published in medical journals and provided to U.K. regulators so they can decide whether to authorize distribution of the vaccine. Those reports will include a detailed breakdown that includes demographic and other information about who got sick in each group, and give a more complete picture of how effective the vaccine is.

Moncef Slaoui, who leads the U.S. coronavirus vaccine program Operation Warp Speed, said Tuesday in a call with reporters that U.S. officials are trying to determine what immune response the vaccine produced, and may decide to modify the AstraZeneca study in the U.S. to include a half dose.

“But we want it to be based on data and science,” he said.

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