FDA Authorizes Second Dose of Omicron-Targeting COVID-19 Vaccines for Older Adults

(CTN News) – On Tuesday, the Food and Drug Administration approved a second COVID-19 vaccine dose for individuals aged 65 and up and those with compromised immune systems.

New Primary COVID Vaccine Targets Omicron Variant

The FDA has announced that the revised COVID-19 vaccines from Pfizer (PFE.N)-BioNTech (22UAy.DE) and Moderna (MRNA.O) will replace the previously approved messenger RNA vaccines that protect against only the first coronavirus strain.

The revised “bivalent” booster vaccine can now be given to those aged 65 and up four months after the initial dosage, while those with weaker immune systems can receive a second shot of the vaccine two months after the initial.

“We’re hoping that it will encourage people who have not received the bivalent booster to go out and consider getting one,” Dr. Peter Marks, head of the FDA’s Centre for Biologics Evaluation and Research, said at a news conference.

He said that only a minority of those over 65 in the United States had received a bivalent booster.

The FDA’s ruling precedes the U.S. government by one day. Expert advisors to the Centres for Disease Control and Prevention (CDC) discuss improving U.S. Advice on protecting yourself from COVID-19.

Expert Group Recommends 6-Month Interval for Booster Shots for People Over 65

The panel is not expected to vote on the use of the second Omicron customized injections from Pfizer-BioNTech and Moderna; nonetheless, the director of the CDC must give his or her approval for the shots’ widespread distribution.

In February, an expert advisory group concluded that additional booster shots for COVID-19 beyond once per year lacked sufficient evidence to warrant a recommendation.

Marks stated that he thinks the data support a six-month interval for those over 65. He speculated that the frequency of booster doses should be administered to immunocompromised persons should be determined individually.

In August, the FDA approved COVID boosters with a new formulation that targets coronavirus subvariants BA.4 and BA.5 Omicron in addition to the original strain. Since then, over 85% of COVID-19 injections given in the United States have been bivalent doses, as reported by the CDC.

However, only about 17% of Americans have modernized boosters. The uptake is higher in the elderly, with nearly 43% of those 65 and older getting the newer dose.

The FDA is moving towards an annual COVID booster campaign with an updated strain, similar to how Americans get flu shots, and this has resulted in the revocation of permission for the initial COVID-19 vaccines.

Marks explained that the vaccine would be composed of “what we believe to be likely to circulate the following fall-winter season.”

Vaccine makers would presumably revise their products in response to the FDA’s announcement to convene an advisory meeting in June to review the strain composition.

Novavax to Update Vaccine for Fall Campaign

While protein-based shots may take longer to create than their mRNA counterparts, Novavax Inc (NVAX.O) is preparing to update its vaccine for the fall, having missed out on the pandemic vaccine bonanza enjoyed by rivals Pfizer and Moderna.

Novavax has stated that the FDA’s notification from Tuesday will not affect the distribution of the company’s vaccines.

The business has stated that it is producing many vaccine possibilities while waiting for regulatory permission and is working closely with the FDA to create a new vaccine for the upcoming fall campaign.

Marks stated that the FDA was “working with all the different companies to try to make sure that we have the appropriate vaccines available, timely, for the fall.”

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