Pfizer, Moderna score FDA nods for COVID boosters in all adults, setting up high-stakes CDC meeting

The race between Moderna and Pfizer to gain FDA nods for their COVID-19 vaccines as boosters in all adults has ended in a dead heat.

On Friday morning, the FDA simultaneously expanded emergency use authorizations for both mRNA vaccines to be used as boosters in adults 18 and older.

The regulator ruled that those who have been vaccinated with any FDA-authorized shot are eligible for either booster. The dose can be administered no sooner than six months after completion of the primary vaccination series. Those who received the single-dose Johnson & Johnson vaccine are eligible for a booster dose of any of the vaccines after two months.

A CDC advisory committee of vaccine experts will meet this afternoon to provide further direction on how the booster rollout should proceed.

Pfizer, along with its development partner BioNTech, were first to the booster finish line on September 22, winning FDA authorization for those 65 and older as well as for those with conditions that put them at greater risk of developing a severe form of the disease and for others that have jobs that make them more prone to exposure. Moderna’s nod for the same population came four weeks later.

Pfizer's booster dose is the same strength as the original two-dose series. Moderna's booster is a 50 mg dose, half the size of the shots in its original series.

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The sweeping move comes just two days after Moderna submitted its application with data updated from its original submission in September. A day earlier, Pfizer resubmitted its booster application.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a release.

Both companies have provided evidence that vaccine strength wanes over time and that a booster provides additional protection. In October, Pfizer said that a booster dose administered to individuals who previously received its vaccine showed an efficacy of 95% compared to those who did not receive a booster.

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“With boosters, more adults will now have the opportunity to help preserve a high level of protection against the disease,” Pfizer CEO Albert Bourla said in a statement.

Pfizer said its booster authorization was unlikely to affect existing supply agreements.