Covid-19 roundup: AstraZeneca struggling to compile data for FDA OK — report
Over a month after announcing Phase III data for the Covid-19 shot, AstraZeneca still has not filed an FDA OK. And it could be another few weeks before the Big Pharma does.
AstraZeneca executives recently told the FDA they might need until mid-May to apply for an emergency use authorization, the Wall Street Journal reported. When they had announced the data in March, the company said they would file by mid-April.
The drugmaker hasn’t filed yet because they’re struggling to collect data that other vaccine developers didn’t have to deal with before they went to the agency: real-world evidence, including for safety, efficacy and transmission, from months of vaccinations in the UK, where the vaccine was first rolled out in late December, according to the WSJ. Pfizer, Moderna and J&J all applied in the US before the vaccine was OK’d anywhere else.
Although US officials, including Anthony Fauci, have said publicly that the US is unlikely to need the AstraZeneca vaccine, the company’s $1.2 billion contract with the US requires it to file in the country.
The company also wants to the FDA’s seal of approval because they hope that it can bolster confidence in the shot worldwide, the WSJ reported. Many countries around the globe, including low- and middle-income countries, have relied on the vaccine but concerns over a serious but rare blood clotting disorder associated with the vaccine have made individuals hesitant and led multiple governments to restrict its use to certain populations.
European regulators and outside experts have said the risks of getting Covid-19 far exceed the risks of the vaccine.
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