Pfizer's current shot with BioNTech protects against severe diseases, but the drugmaker believes that a booster is necessary to prevent infections.
"Right now it is necessary to add a fourth booster. It is good enough to protect you from the third. In fact, it is quite good for hospitalizations as well as deaths. It doesn't protect against infections," Pfizer CEO Albert Bourla said to "Face the Nation " during a Sunday interview .
Pfizer spokesperson Steven Danehy said Bourla meant "early and preliminary" data. He pointed to a January study that examined both the current-authorized formulation and one specifically designed to target Omicron variants.
Danehy stated in a statement that "We will continue collecting and assessing all data and remain open to dialogue with regulators, health authorities, and other stakeholders to inform a COVID-19 vaccination strategy as the virus evolves."
A spokesperson for the White House referred questions about the submission to FDA. The agency did not respond to requests for comment.
Bourla previously stated that the submission was a "significant package" of data regarding the need for a fourth dose in an interview. These conclusions are consistent with trends that have been observed by global health authorities who studied vaccination effectiveness during this year's Omicron wave.
The Centers for Disease Control and Prevention published a cohort study that found vaccine effectiveness against COVID-19 urgent care visits and emergency rooms had dropped to 66% in those who had received the third dose of the mRNA vaccinations at least four to five months prior. This group was 78% more likely to be hospitalized for COVID-19 than the vaccine.
Bourla stated that the company was trying to develop a new vaccine, "that will protect against all variants of Omicron but also something that can last at least one year."
"Omicron was first to be able to evade, in a skillful manner, the immune protection we're giving. He also said that protection doesn't last for very long.
Federal health officials previously stated that a booster shot may be necessary to prevent new waves of the virus. However, this could not happen until the fall for most people.
"The hope is that after our third shot we're able get enough time from them that we end up with essentially a annual COVID-19 booster," Dr. Peter Marks of the FDA, who was speaking at an event hosted by Stanford University and the University of California San Francisco in January.
Moderna executives echoed this timeline. They are also racing to test new COVID-19 vaccines.
"It's time to update the vaccine to combat the mutations currently in circulation, and to increase the durability against these new variants of concern. It does face the challenge of those filings," Moderna president Stephen Hoge said to investors.
Officials have indicated that the fourth dose timeline could be extended for those more susceptible to breakthrough infections due to the spread of the virus .
"I don’t think you’re going to hear, if you do," Dr. Anthony Fauci, President's chief medical advisor, said last month.
According to the figures of the CDC, close to half of all vaccinated adults have had a booster shot and nearly two-thirds of all vaccinated seniors in America have had one.
The pace of hospitalizations and new cases continues to slow in the wake Omicron surge. However, more than 1,000 COVID-19 deaths are still being reported each day.
Europe, which also saw infections drop following the Omicron surge, is seeing the pace of new cases climb as several countries have lifted their pandemic restrictions.
Fauci stated that "it very likely will consider what subsets of people have a diminished or not protection against the important parameters like hospitalization."
