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FDA, CDC advisers say to expect a lot of questions about AstraZeneca Covid-19 vaccine

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Lots of questions.

In interviews with CNN, several U.S. government vaccine advisers did not question whether the AstraZeneca vaccine would eventually obtain FDA emergency use authorization. However, they said the company’s application is likely to raise issues that did not arise when considering the three Covid-19 vaccines currently used in the United States (manufactured by Pfizer, Moderna and Johnson & Johnson). emergency use authorizations.

“Clearly, more questions have been asked about the AstraZeneca vaccine than about any of the other vaccines that are now authorized in the U.S.,” Dr. Arnold Monto, acting chair of the FDA Advisory Committee on Vaccines and Related Biological Products, reviews vaccine applications and advises the FDA on whether they should be authorized.

These advisers – who work in academic medical centers and not for the government – said reports of blood clots after vaccination, which led to more than a dozen Western European countries suspending the use of 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 clot occurred,” said Dr. William Schaffner, a liaison member of the CDC Advisory Committee on Immunization Practices.

AstraZeneca expects to ask the FDA to authorize its Covid-19 vaccine for emergency use in March or early April, sources familiar with the company’s ongoing clinical trial told Reuters.

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

“I’m going to have an open mind to these deliberations,” said Dr. Ofer Levy, a member of the FDA’s vaccine advisory committee.

“I’ll go where the data takes me,” said another member, Dr. H. Cody Meissner.

As more and more European countries have suspended the launch of the AstraZeneca vaccine, the company, as well as international health agencies, have championed the vaccine.

“Everyone’s safety is our number one priority,” according to an AstraZeneca statement sent to CNN on Wednesday. “Around 17 million people in the EU and the UK have received our vaccine and the number of blood clot cases reported in this group is less than the hundreds of cases that would be expected among the general population.”

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

Despite this support, several U.S. government advisers said they are concerned that after months of hearing questions about the AstraZeneca vaccine, many Americans may perceive it as problematic and will not want to take it. .

“It’s hard to open that bell,” said Dr. Paul Offit, a member of the FDA’s advisory committee. “Once people are scared, it’s hard to waste it.”

New report on blood clots

According to an EMA statement issued on Thursday, “the [AstraZeneca] the vaccine is not associated with an increased risk of blood clots. ”

The statement notes that in the UK and the European Union, in addition to Iceland, Liechtenstein and Norway, around 20 million people received the AstraZeneca vaccine on March 16 and had been informed of some specific types. of rare clotting problems related to low blood platelets.

The number of reports of these rare clotting problems “exceeds expectations and therefore causation cannot be ruled out, although it is not confirmed,” according to the statement, which notes that vaccine labeling is will update to include more information about these events.

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

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

“One mistake after another”

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

South Africa pauses launch of AstraZeneca vaccine after study shows less protection against variants
Last spring and summer, Oxford researchers he said it as the first-place finisher, though they would sometimes step back and warn of over-promising ones.

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

But it’s a year ahead and AstraZeneca has faced challenges. Twice put his clinical trials on hold when participants who received the vaccine became ill; both were restarted when it was determined that the diseases were not vaccine-related.
In November, questions it emerged from the company’s efficacy data and revealed that an error had been made in the trial and that some participants received an incorrect dose. Oxford told CNN at the time that a “difference in the manufacturing process” had caused the error.
“I’ve done a lot of clinical trials with vaccines over the last few decades and that’s never happened,” said Meissner, a member of the FDA’s vaccine advisory committee. “I read his Paper lancet as they explained, but it was a little torturous. ”

Menelas Pangalos, AstraZeneca’s executive vice president of biopharmaceutical R&D, told the Wall Street Journal in November that “the mistake was really irrelevant” and that the vaccine “meets the approval threshold with a vaccine that exceeds 60% of efficiency “.

Then last month, South Africa paused the launch of the AstraZeneca vaccine after a study showed that it offered less protection against the coronavirus variant that was first identified. This study, published later in the New England Journal of Medicine, found that the AstraZeneca vaccine “showed no mild to moderate protection against Covid-19” due to the variant.
Biden administration finalizes plans to send millions of doses of AstraZeneca vaccine 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 pretty reluctant British people beating their own drums: ‘We’ll be the first, we’ll be the best’ – and this is the vaccine that has one mistake after another,” he said. Schaffner.

An AstraZeneca spokesman told CNN in the Lancet study published in January that it found the vaccine to have “an acceptable safety profile and has been shown to be effective against symptomatic COVID-19.”

An AstraZeneca press release On Sunday, he said that of the 17 million people who received the vaccine in the European Union and the UK, there were 15 events of deep vein thrombosis and 22 events of pulmonary embolism, according to information the company had received on 8 of March.

“This is much lower than expected to occur naturally in a general population of this size,” according to the company’s statement, which added that “there was no evidence of an increased risk of embolism. pulmonary, deep vein thrombosis (DVT) thrombocytopenia, in any age group, gender, defined batch or in any particular country. ”

The press release did not mention the rare types of clotting events discussed on Thursday by European regulators.

Agreements for 300 million doses of AstraZeneca

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

Although government advisers said better vaccine is better, they say it is unclear what role AstraZeneca doses would play if the vaccine was authorized.

There will be more than enough vaccine of Pfizer, Modern and Johnson & Johnson to vaccinate all American adults in late May, said Jeff Zients, White House coordinator, Covid, Jeff Zients.

CNN government advisers said that if the AstraZeneca vaccine is distributed in the U.S., they are concerned that Americans may perceive it to be less than the three that are already being distributed.

“I’m very concerned that there will be a lot of people who will say‘ thank you very much but not ’to AstraZeneca for all this publicity,” said Schaffner, the CDC advisor.

He said that if there is not enough demand for it, the United States could donate part of its AstraZeneca supply to developing countries, where it would be especially useful because it is easier to transport and store that Pfizer or Moderna vaccines.

The Biden administration has already announced plans to ship several million doses of AstraZeneca to other countries.

“I can confirm that we have 7 million deliverable doses of AstraZeneca available,” White House press secretary Jen Psaki told the White House press on Thursday information session. “2.5 million of these, we are working to finalize plans to lend them to Mexico and 1.5 million to Canada.”

“We could be similar to Solomon and cut the baby in half and say we have contracted the purchase of these doses, we will use a third and give the rest to developing countries and do some vaccine diplomacy,” he said. Schaffner. “That’s a possibility.”

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

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