Pfizer seeks U.S. approval for booster vaccine; WHO says first shot

(Reuters) -Pfizer Inc on Wednesday began the process for full approval of its COVID-19 booster dose in the United States even as the World Health Organization said data on its benefits are inconclusive and that focus must be to cover the unvaccinated.

The drugmaker and its German partner BioNTech aim to complete the submission for use of booster shots in people aged 16 and above by the end of this week.

The U.S. government has said it was gearing up to roll out the third shot from mid-September to Americans who had their initial course more than eight months ago if the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention decide that boosters are needed.

Israel began rolling out boosters at the beginning of August to older citizens and this week expanded the drive to people as young as 30, saying the shots were helping increasing protection against the highly infectious Delta variant.

U.S. President Joe Biden too has shown his support for booster shots, saying, “It’s the best way to protect ourselves from new variants that may arise.”

However, WHO Director General Tedros Adhanom Ghebreyesus said the data on the benefits and safety of a COVID-19 vaccine booster shot is inconclusive.

The health agency yet again called for a delay in rolling out booster shots and instead aim for higher vaccination rates in countries where many had not received even the first or second shot.

The WHO had called for a moratorium on boosters until at least the end of September.

Earlier this week, U.S. regulators granted full approval to the two-dose vaccine, which has been available up until now under emergency use authorization.

The approval spurred some local governments, such as New York City and the state of New Jersey, as well as the U.S. military and some companies to mandate vaccines.

A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the United States.

However, under the amended Emergency Use Authorization, a third dose was authorized for administration to individuals at least 12 years of age who were immunocompromised.