Need 2-month data to approve COVID-19 vaccine: US FDA

By Rahul Vaimal, Associate Editor
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The US Food and Drug Administration (FDA) has finally made its process behind COVID-19 vaccine approval public answering some very critical questions on why the US has been considerably slow in sanctions for the vaccine compared to its counterparts. 

Authorities made it clear that they require at least two months of follow-up data after trial volunteers have their second dose wherever it is applicable to provide any form of emergency approval for a COVID-19 vaccine.

Also Read: COVID-19 vaccine by year-end possible; WHO Chief

The latest update from the country’s federal agency makes it highly unlikely to have an approved COVID-19 vaccine available for the public before the much-hyped President Donald Trump’s timeline of November 3 when the nation goes for Presidential poll.

The newly released document from the FDA stated that “Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile.”

Both US-based vaccine manufacturers Moderna and Pfizer began their series of final stage trials in late July with both requiring two separate injections 28 days apart as part of their regimen.

That timeline would provide only very little data (mostly from the initial volunteers) to be available by the end of October making the results inconclusive to be used as valid proof of the vaccine’s efficacy leading to any approvals.

Stephen Hahn, Commissioner of Food and Drugs at the federal agency commented that “FDA is committed to making the COVID19 vaccine development process & our scientific evaluation as open & transparent as possible.”

The news has received mixed responses from various sections with President Trump disapproving of the move saying “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”. US Media reported that Capitol Hill saw the two-month follow-up period as unnecessary and did not want the FDA to implement it.

Meanwhile, health experts in the country welcomed the judicious move by the FDA remarking it as a sign of the agency acting responsibly in the face of political pressure.

Related: COVID-19 vaccine trials on children should resume immediately: Oxford