Pfizer Wants to Obtain Authorization for a Booster Dose

Pfizer developed one of the most effective COVID-19 vaccines in the world, but as the COVID-19 continues to evolve, it is important to take additional measures to protect people from the virus. The company plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine in the near future.

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention released a statement on July 8. Americans who received both doses don’t need a booster for COVID-19 shot at this time according to a joint statement. Some scientists also questioned the need for booster shots.

The company’s own data from the U.S. showed an erosion of the vaccine’s efficacy to the mid-80s after six months, against the variants that circulated in the U.S. in the spring. The data from the U.K. and Israel suggests that even with the waning antibody levels, Pfizer’s vaccine is 95% effective against severe disease. The vaccine also showed 95% efficacy in preventing symptomatic COVID-19 in a clinical trial conducted by Pfizer and BioNTech SE. The companies conducted this trial in 2020.

 Pfizer wants to make 3 billion doses in 2021

Pfizers’ own studies show that a booster generates antibody levels that are five-to-10-fold higher than after the second dose. The data stated above shows that a third dose will offer promising protection against COVID-19.

Multiple countries in Europe and elsewhere already approached the company to discuss booster doses. Some countries may begin administering booster doses before a potential U.S. authorization.

Pfizer previously said people would likely need an additional dose, but some scientists questioned when, or whether, boosters will be needed. The company plans to launch a placebo-controlled efficacy trial of the booster with 10,000 participants in the near future. Even if the company succeeds in getting its booster dose authorized by the FDA, that would be only the first step. The booster dose would still need to be reviewed and recommended by advisers to the CDC.

Because boosters would drive increasing demand for vaccines, the company is looking at ways to boost production. Pfizer wants to make 3 billion doses in 2021 and 4 billion doses in 2022.

Pfizer and BioNTech are also designing a new version of the COVID-19 vaccine to deal with the Delta variant. Hopefully, there is no need to replace the current version to tackle the variant according to companies.

Unsurprisingly, Pfizer expects the COVID-19 vaccine to be the main revenue contributor for years. Global spending on COVID-19 vaccines, as well as booster shots, could total $157 billion through 2025.