The US biotech company Novavax said on Monday it hoped to file an application for authorization for its Covid-19 vaccine in the UK at the start of the second quarter of 2021, and to be able to do the same soon after in the United States.
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However, it has no assurance that the US authorities will agree to study this request, which will for the moment be based only on the results of phase 3 clinical trials conducted in the United Kingdom, while other similar are still going on in the United States.
The data should be submitted to the British health regulator (MHRA) "
by the start of the second quarter of 2021,
" Novavax said in a statement, on the occasion of the publication of its quarterly results.
“Different” data from AstraZeneca
A “
dialogue
” has also been initiated with the US Medicines Agency (FDA), “
with a potential request for an authorization for emergency use in the second quarter of 2021,
” the statement continued.
“
Our hope and expectation is that the FDA will agree to consider the UK data,
” Novavax CEO Stanley Erck told CNBC, admitting that he had no “
assurance
” that it would.
For the AstraZeneca vaccine, the American health authorities are awaiting the results of trials in the United States, even if this remedy is already authorized in Europe.
"
We have different data from those of AstraZeneca
", argued Stanley Erck, however.
If the FDA refuses to study the British data from Novavax, the procedure will be postponed until the results of its trials in the United States and Mexico, for which 30,000 volunteers have been vaccinated, are known.
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This will be the case a priori "
in the second quarter of 2021
", depending on the virulence of the Covid-19 epidemic in these countries, according to the Novavax press release.
Clinical trials conducted in the United Kingdom involved 15,000 people, and demonstrated an efficacy of 89.3% for this vaccine, the company announced at the end of January.
In detail, the Novavax vaccine was 95.6% effective against the initial strain of Covid-19, and 85.6% against the British variant.
The British government has secured an order for 60 million doses of Novavax's vaccine.
