'Not rooted': US FDA warns against 'premature' changes in dosing strategy of COVID vaccine

The United States Food and Drug Administration (FDA) on Monday said that it does not recommend changing the dosing schedule of vaccines amid discussions to delay the second shot in order to inoculate as many people as possible. FDA on January 4 issued a statement reminding the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized in order to replicate the result observed during the trials. 

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"We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence," FDA said in a statement. 

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UK, Canada changed its strategy

Earlier, the US government had said it was contemplating changing its vaccine strategy in order to speed up the immunisation process in the country. Moncef Slaoui, head of Operation Warp Speed, had said that the US government is in talks with Moderna and FDA to seek more information on whether it is safe to change the dosing schedule of the vaccine. The FDA has now cleared the air saying it doesn't recommend extending the window between each jab and would advice to follow the authorised schedule.

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The United Kingdom and Canada changed their vaccination strategy last week, approving to not hold back doses for booster shots so they can inoculate as many people as possible with prime shots. Germany and Denmark are also planning to change its strategy. Earlier, Pfizer and BioNTech said that they do not have evidence to suggest their COVID-19 vaccine will continue to generate an immune response if the second shot is delayed by more than 21 days.

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