AstraZeneca may be expected to apply for emergency use authorization for its Covid-19 vaccine in the US, CNN reported. In the event the US Food and Drug Administration advisers would likely have some questions for the company, CNN added.
AstraZeneca May Need To Answer Many Questions For Authorization Of Covid-19 Vaccine In The US.
CNN said that several vaccine advisers to the US government it interviewed had no doubt as to the company’s vaccine, ultimately gaining the emergency use authorization from the FDA. They added, however, that the company’s application would likely raise issues that did not arise at the time of the use of Pfizer, Moderna and Johnson & Johnson’s Covid-19 vaccines for their own emergency use authorizations.
Dr Arnold Monto, FDA’s Vaccines and Related Biological Products Advisory Committee, acting chair, said it was clear more questions had been raised about the AstraZeneca vaccine than about any of the other vaccines. The committee is tasked with reviewing vaccine applications and advising the FDA on their authorization.
According to the advisers who worked at academic medical centres and not for the government, the reports of blood clots after vaccination, over which more than a dozen western European countries had suspended the use of the AstraZeneca vaccine, were not the only issue.
Other aspects of the vaccine’s efficacy and safety data, too, had been questioned. According to Dr. William Schaffner, a liaison member of the Advisory Committee of the ICC on Immunization Practices, it did feel different, and it had felt different even before the blood clot issue came to light.
Reuters, which spoke to sources with knowledge of the company’s ongoing clinical trials, said the company expected to ask the FDA for authorization of its Covid-19 vaccine for emergency use in March or early April.
According to Schaffner, Monto and other government advisers, they looked forward to receiving the “dossier” of data about the efficacy and safety data released publicly by the FDA when a pharmaceutical company applied for emergency use authorization.
CNN quoted Dr Ofer Levy, a member of the FDA’s vaccine advisory committee, that he would bring an open mind to the deliberations.
Another member, Dr H. Cody Meissner, added he would go where the data led him.
With the suspension of their Astra Zeneca rollout by a growing number of European countries, the company and international health agencies had defended the vaccine.
AstraZeneca said in a statement sent to CNN Wednesday that the safety of all was the first priority of the company. It added that around 17 million people in the EU and UK had been administered the company’s vaccine. The number of cases of blood clots reported in this group was lower than the hundreds of cases that would be expected among the general population.
The company’s vaccine had also received the World Health Organization, UK health authorities, and the European Medicines Agency, saying its benefits outweighed any risks.
According to several US government advisers, the support notwithstanding, they worried that after months of hearing about AstraZeneca’s vaccine questions, it might be perceived by many Americans as problematic, and they would not want to take it.
According to Dr Paul Offit, a member of the FDA advisory committee, it was hard to unring that bell. He added if once people were scared, unscaring them would not come easy.
The EMA said in a statement issued Thursday; the [AstraZeneca] vaccine did not carry the risk of an overall increase of blood clots.
The statement added that around 20 million people in the UK and the European Union and Iceland, Norway, and Liechtenstein had been administered the vaccine as of March 16. It added some specific types of rare clotting problems linked to low blood platelets had been reported.