Pfizer Submits Data to FDA Showing a Booster Dose Works Well Against Original Coronavirus and Variants

Pfizer and BioNTech said Monday they have submitted initial data to the Food and Drug Administration to support the use of a booster dose of COVID-19 vaccine.

The booster dose elicited a significantly higher antibody response against the initial strain of coronavirus and the delta and beta variants, compared to what was seen among people who got two doses. The booster dose seemed to be equally protective against the delta and beta variants as against the original coronavirus.

"Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19," the company said in a statement.

"This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine," added Dr. Ugur Sahin, CEO and Co-founder of BioNTech. "A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season."

The data on booster shots comes as COVID-19 cases and hospitalizations have surged in recent weeks, particularly among unvaccinated people in the South. Pfizer executives say they believe a booster dose will be needed soon, but U.S. health officials say they have seen no indication one is needed yet.

Last week, the FDA and Centers for Disease Control and Prevention authorized and recommended a third dose of vaccine for some immunocompromised people who likely had little or no response to the first two shots.

Still, health officials have focused on convincing unvaccinated people to get protected. As of Monday, 50.7% of the total U.S. population was fully vaccinated, including 59.3% of those eligible, according to data from the US Centers for Disease Control and Prevention.

Cases are surging in 40 states, according to data from Johns Hopkins University. Soon, the U.S. could be reporting more than 200,000 new cases a day, the director of the National Institutes of Health predicted Sunday. That's a rate not seen since before vaccines became widely available.

"That's heartbreaking considering we never thought we would be back in that space again," Dr. Francis Collins said on Fox News.

Pfizer and BioNTech said they expect results from the trial to evaluate a booster dose "shortly" and the companies plan to submit the data to the FDA and other regulatory authorities. The companies plan to submit this early data to the European Medicines Agency and other regulatory authorities in the coming weeks.

Pfizer and BioNTech said after FDA grants approval for their vaccine in the U.S., they would then seek approval of a booster dose through a supplement to their license application. The companies said they would seek approval for this booster dose for people 16 or older. Currently the Pfizer COVID-19 vaccine is authorized for people 12 and older.

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Source: KCRA

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