Will American adults have access to a fourth shot of COVID-19 vaccine? Pharmaceutical manufacturer Moderna has asked the Food and Drug Administration to approve a fourth shot of its COVID-19 vaccine as a booster dose for all adults.
However, rival pharmaceutical company Pfizer’s request for approval of a booster shot was for seniors only.
U.S. officials have laid the groundwork for providing additional booster doses to strengthen vaccines’ protection against serious illness and death from COVID-19. The White House has sounded the alarm that it needs Congress to “quickly” approve more funds for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.
US health authorities are currently recommending a primary series of two doses of the Moderna vaccine and a booster dose months later.
Moderna said their request for an additional dose was based on “recently published data generated in the United States and Israel following the advent of Omicron.”
Last Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to approve an extra booster dose of their COVID-19 vaccine for seniors.
The New York-based drug maker and its German partner BioNTech SE said they have applied for an emergency permit for another booster of their vaccine, Comirnaty, for people 65 and older who have already received a booster from any of the approved COVID-19 vaccines.
Pfizer and BioNTech said they submitted data to the FDA from Israel, which began offering a fourth shot to elderly people and healthcare professionals last year when the omicron variant was circulating.
In a press release announcing its application to the FDA, Pfizer said an analysis of Israeli medical records showed that the number of confirmed infections in people 60 years and older who received a new booster was half of those seen in their counterparts who had received only three doses of the vaccine. In addition, the likelihood of developing severe COVID-19 was four times lower in the group that received another booster, the company said.
Pfizer’s FDA application also included results from an unspecified clinical trial where it offered another booster shot to Israeli health workers who wanted it. Among the 154 workers who received the fourth shot, neutralizing antibodies increased by a factor of seven to eight, and antibodies specific for the omicron variant increased by a factor of eight to 10, Pfizer said.
While the design of the study and the names of researchers conducting the trial are unclear in Pfizer’s press release, these findings appear to reflect a segment of the population that was the subject of Wednesday’s New England Journal of Medicine study.
While vaccine experts are awaiting a more detailed account of the data cited by Pfizer, they pointed to the recently published Israeli study as evidence that any discussion of second-booster-for-all is premature.
In the United States, individuals 12 years of age and older can receive a single booster dose of the Comirnaty vaccine if they have already completed the Pfizer-BioNTech regimen with two doses. Among those who originally got a shot developed by Moderna Inc. or Johnson & Johnson, only those 18 years and older can get a Comirnaty booster.
Individuals who received a third dose generally outperformed the delta and omicron variants than individuals who received only two doses, according to studies published by the Centers for Disease Control and Prevention earlier this year.
While COVID-19 cases have fallen sharply from their winter peak, there are signs that another rise in infections may be in the cards in the coming weeks. More than a third of CDC wastewater testing sites in the United States showed rising virus trends earlier this month.
Pfizer is also studying an omicron-specific vaccine and a hybrid shot that will target omicron along with previous variants. The company is expected to report data on this effort in April.
The CDC recommends that some immunocompromised individuals receive a three-dose primary series of mRNA shots and a fourth shot as a booster.
Dr. Paul Offit, an infectious disease expert at the Children’s Hospital of Philadelphia, said that for older and sicker Americans, three vaccination shots should probably be considered the primary series. The case for a possible fourth shot – a booster – for these Americans has not yet been made, he added.
In most people, two to three doses or mRNA vaccine has largely eliminated the threat of an infection developing into serious illness or death, Offit said. It will be difficult to detect that the immune system needs more vaccine to protect itself against the SARS-CoV-2 virus, he added.
“If we are to get past this pandemic, we need to realize that protection against mild illness will not last long,” Offit said. The key to this is to recognize that infections that are little more than a snuff and cough do not warrant a strenuous effort to prevent. “As long as the protection against serious illness lasts, we should consider it a victory,” he said.
– The Associated Press, Bloomberg News and the Los Angeles Times contributed to this report