The FDA approves the Novavax COVVI-19 vaccine, but with unusual restrictions on its use

Washington (AP) – The Food and Drug Administration issued a long -awaited approval of the Novavax COVI -19 vaccine but with unusual restrictions.

Novavax makes the only traditional vaccine based on protein -based coronaviruses – and so far, he has had an emergency authorization from the FDA for use in anyone 12 and over.

But Friday evening, the FDA granted complete approval of the company for its vaccine for use only in adults aged 65 and over – or 12 to 64 years old who have at least one health problem that presents them at increased risks of COVID -19.

Vaccines produced by competitors of Novavax, Pfizer and Moderna, are already fully authorized for use in anyone about 12 years and over, and are also authorized for use in children as young as 6 months.

Find out more: 5 years after it appeared, the things we know and that we still do not know on COVIvi

Next month, influential Centers for Disease Control and Prevention advisers were to debate if annual vaccines are still recommended for everyone or only some people at higher risks. Novavax’s decision suggests that the Trump administration may have already decided how to proceed before this meeting.

The director general of Novavax, John C. Jacobs, praised the license.

“Market studies and American CDC statistics indicate that older individuals and those who suffer from underlying conditions are the most likely populations to seek the vaccination of seasonal COVIR-19.

In its letter of approval on Friday, the FDA did not explain the restrictions although they reflect skepticism as to the vaccines of the health secretary Robert F. Kennedy Jr. and other officials of Trump.

Novavax initially shown that its vaccine was safe and effective in a clinical trial of 30,000 people. The FDA had been on the right track to grant Novavax a complete approval – without restrictions – on its target date of April 1, according to two people with direct knowledge of the situation which spoke under the cover of anonymity to discuss the agency’s confidential issues.

Novavax then announced that the FDA asked him in place to conduct an additional test after approval, which is very unusual. The FDA has ordered that several additional trials are completed in the coming years, some examining if the vaccine could be associated with certain heart conditions. Another required study must assess the advantages of pursuing vaccination in children aged 50 to 64 which have no health problems that increase their risk of COVID-19.