FDA, CDC advisers say to expect many questions about AstraZeneca Covid-19 vaccine

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Many questions.

In interviews with CNN, several US government vaccine advisers left no doubt that AstraZeneca’s vaccine would eventually receive FDA approval for emergency use. However, they said the company’s filing was likely to pose problems that weren’t addressed when the three Covid-19 vaccines currently in use in the United States – made by Pfizer, Moderna, and Johnson & Johnson – run for their own. were considered. authorizations for emergency use.

“It is clear that more questions have been raised about the AstraZeneca vaccine than any other vaccine now authorized in the US,” said Dr. Arnold Monto, acting chair of the FDA’s Vaccines and Related Biological Products Advisory Committee, saying vaccine. applications and advises the FDA whether they should be authorized.

Those advisers – who work in academic medical centers and not for the government – said the reports of post-vaccination blood clots causing more than a dozen Western European countries to stop using the AstraZeneca vaccine are not the only problem. Questions have also been raised about other aspects of AstraZeneca’s efficacy and safety data.

“It feels different, and it felt different even before the blood clot formed,” said Dr. William Schaffner, a liaison member of the CDC’s Advisory Committee on Immunization Practices.

AstraZeneca expects to ask the FDA to approve its Covid-19 emergency vaccine in March or early April, sources with knowledge of the company’s ongoing clinical trial told Reuters last week.

Monto, Schaffner and other government advisers said they look forward to receiving the “dossier” of data on the safety and efficacy of a vaccine that the FDA publicly releases when a pharmaceutical company applies for an emergency use authorization.

“I will be open to these deliberations,” said Dr. Ofer Levy, a member of the FDA’s vaccine advisory committee.

“I’m going where the data leads me,” said another member, Dr. H. Cody Meissner.

As more and more European countries have suspended their rollout of AstraZeneca vaccines, the company, as well as international health authorities, have defended the vaccine.

“Everyone’s safety is our number one priority,” said a statement from AstraZeneca sent to CNN on Wednesday. “About 17 million people in the EU and the UK have now received our vaccine and the number of blood clots reported in this group is lower than the hundreds of cases expected in the general population.”

The World Health Organization, UK health authorities and the European Medicines Agency have all expressed support for the AstraZeneca vaccine, saying the benefits outweigh any risks.

Despite this support, several US government advisers said they are concerned that many Americans will find it problematic, after hearing for months about questions related to the AstraZeneca vaccine.

“It’s hard to let go of that bell,” said Dr. Paul Offit, a member of the FDA Advisory Committee. “Once people are scared, it is difficult to wake them up from sleep.”

New report on blood clots

According to a statement from the EMA released Thursday, “the [AstraZeneca] vaccine is not associated with an increase in the overall risk of blood clots. ”

Have European countries made a mistake when stopping AstraZeneca recordings? This is what health experts say

The statement noted that about 20 million people in the UK and the European Union, as well as in Iceland, Liechtenstein and Norway, received the AstraZeneca vaccine on March 16, and there were reports of some specific types of rare clotting problems related to with low blood clotting. platelets.

The number of reports of those rare clotting problems “exceeds what was expected, and causality, while not confirmed, therefore cannot be ruled out,” the statement said, noting that the vaccine labeling will be updated with more information on these events.

One type of clot is mesenteric venous thrombosis, which is a clot in one or more of the main veins that drain blood from the intestines. Another is cerebral sinus venous thrombosis, where a clot forms in the brain’s drainage system. A third is disseminated intravascular coagulation, which is blood clots in multiple blood vessels.

The EMA said it had assessed seven cases of disseminated intravascular coagulation and 18 cases of cerebral sinus venous thrombosis as of March 16.

‘One failure after another’

The AstraZeneca vaccine, which was developed in collaboration with the University of Oxford, started with a reputation for being one of the world’s most promising Covid-19 vaccines.

South Africa pauses AstraZeneca vaccine rollout after study shows it offers less protection against variant
Last spring and summer, Oxford researchers named it as a front runner, though they came back later at times and warned against being too promising.

Dr. Adrian Hill, one of the leading Oxford scientists, at times even insulted other vaccine manufacturers, calling the Modern’a Covid-19 vaccine technology “weird” and “unproven”, for example.

Just a year ahead, and it is AstraZeneca that faced challenges. Twice it stopped its clinical trials when participants who received the vaccine became ill – both times it was restarted when the diseases were found to be unrelated to the vaccine.
In November, questions arose about the company’s efficacy data and it was revealed that a mistake had been made in the study and that some participants were being given the wrong dose. Oxford told CNN at the time that a “difference in the manufacturing process” had led to the error.
“I’ve done a lot of clinical trials on vaccines over the past few decades and it never happened,” said Meissner, a member of the FDA’s vaccine advisory committee. “I read in their Lancet paper how they explained it, but it was a bit torturous.”

Menelas Pangalos, executive vice president for biopharmaceutical R&D at AstraZeneca, told the Wall Street Journal in November that “the error was actually irrelevant” and that the vaccine “meets the threshold for approval with a vaccine that is more than 60% effective. is. ”

Last month, South Africa subsequently halted the rollout of the AstraZeneca vaccine after a study found it offered less protection against the coronavirus variant first identified there. That study, later published in the New England Journal of Medicine, found that the AstraZeneca vaccine “showed no protection against mild to moderate Covid-19” because of the variant.
Biden administration finalizes plans to send millions of AstraZeneca vaccine doses to Canada and Mexico

Currently, more than a dozen European countries have suspended the use of the vaccine due to concerns about blood clots.

“It’s so ironic – last summer there were these usually rather reluctant British down beating their own drums – ‘We will be the first, we will be the best’ – and this is the vaccine that has had one failure after another” , Schaffner said.

An AstraZeneca spokesman pointed out to CNN the Lancet study, published in January, which found the vaccine “had an acceptable safety profile and was shown to be effective against symptomatic COVID-19”.

A press release from AstraZeneca on Sunday said that of the 17 million people who received their vaccine in the European Union and the UK, there were 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism, based on information the company received in March. 8.

“This is much lower than would naturally be expected in a general population of this size,” said the company statement, adding that there was “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in a specific age group, gender, batch or in a specific country. ”

The press release made no mention of the rare types of clotting events discussed by European regulators on Thursday.

Agreements for 300 million AstraZeneca doses

AstraZeneca already has agreements with the US government to deliver 300 million doses, according to prepared comments the company delivered to Congress last month.

While government advisers said more vaccine is better, they say it is unclear what role AstraZeneca doses would play if the vaccine is approved.

By the end of May, there will be more than enough vaccine from Pfizer, Moderna and Johnson & Johnson to vaccinate every American adult, Covid White House coordinator Jeff Zients said earlier this month.

The government advisers who spoke to CNN said that if the AstraZeneca vaccine is distributed in the US, they are concerned that Americans will view it as inferior to the three already distributed.

“I’m really concerned that there will be a lot of people who will thank AstraZeneca very much but say no because of all this publicity,” said Schaffner, the CDC advisor.

He said that if there is not enough demand, the US could donate some of its AstraZeneca supply to developing countries, where it would be particularly useful because it is easier to transport and store than Pfizer or Moderna’s vaccines.

The Biden government has already announced plans to send a few million doses of AstraZeneca to other countries.

“I can confirm that we have 7 million doses of AstraZeneca to be released,” White House press secretary Jen Psaki said at the White House press conference on Thursday. “2.5 million of that, we are finalizing plans to lend them to Mexico and 1.5 million to Canada.”

“We could be Solomon-ish and cut the baby in half and say we’ve contracted to buy these doses, and we’ll use a third of it and give the rest away to developing countries and do a little bit of vaccination diplomacy,” Schaffner said. “That’s a possibility.”

CNN’s Ryan Prior, Samira Said, Michael Nedelman and Casey Hicks contributed to this report.

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