Pharmaceutical giant Pfizer scheduled a meeting with the U.S. health official on Monday, July 12 seeking for an approval for the third dose of COVID-19 vaccine as cases rise across the country.

Pfizer previously asserted that a booster shot of the COVID-19 vaccine is needed within 12 months. They learned from the data that a higher risk of infection is likely to occur six months after the initial inoculation.

The Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC) have turned down the drugmaker company opinion, saying in a joint statement Thursday that “Americans who have been fully vaccinated do not need a booster shot at this time.”

“We are prepared for booster doses if and when the science demonstrates that they are needed,” the CDC and FDA added.

Dr. Mikael Dolsten of Pfizer told The Associated Press that preliminary data from the company’s booster research showed that people’s antibody levels increased five to tenfold after a third treatment, compared to their second dose months before—evidence that he feels justifies the need for a booster.

According to the company, a booster dose within 12 months of the original vaccination could significantly improve protection and possibly help ward against the latest concerning variants.

A day before the meeting, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said clinical studies have not yet proven a need for a booster shot to any of the three vaccines.

“Right now, given the data and the information we have, we do not need to give people a third shot,” he stated on CNN’s State of the Union.

“That doesn’t mean we stop there. … There are studies being done now ongoing as we speak about looking at the feasibility about if and when we should be boosting people,” he continued.

At the same time, Fauci said, it’s “entirely conceivable, maybe likely” that booster shots will be necessary.

“There are studies being done, ongoing as we speak, about looking at the feasibility about if and when we should be boosting people,” he said.

Vaccine makers have previously discussed the possibility of further doses, with Moderna CEO Stephane Bancel saying on a May earnings call that “we believe booster shots will be needed” to combat “new variants of concern.”

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