Heres the latest on possible 4th COVID-19 vaccine shot for Americans – OregonLive

Will American adults have access to a fourth shot of COVID-19 vaccine? Drugmaker Moderna has asked the Food and Drug Administration to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults.

However, rival pharmaceutical company Pfizers request was approval for a booster shot for only seniors.

U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to urgently approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.

U.S. health officials currently recommend a primary series of two doses of the Moderna vaccine and a booster dose months later.

Moderna said its request for an additional dose was based on recently published data generated in the United States and Israel following the emergence of Omicron.

Last Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to authorize an additional booster dose of their COVID-19 vaccine for seniors.

The New York-based drugmaker and its German partner BioNTech SE said that they have sought an emergency-use authorization for a second booster of their vaccine, Comirnaty, for people 65 and older who have already received a booster of any of the authorized COVID-19 vaccines.

Pfizer and BioNTech said they submitted data to the FDA from Israel, which began offering a fourth shot to older people and health-care workers last year as 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 rate of confirmed infections in people 60 and older who received a second booster was half that seen in their counterparts who had had only three doses of the vaccine. In addition, the likelihood of developing severe COVID-19 was four times lower in the group that got a second booster, the company said.

Pfizers FDA application also included results of an unspecified clinical trial in which it offered a second booster shot to Israeli health care workers who wanted it. Among the 154 workers who got the fourth shot, neutralizing antibodies rose by a factor of seven to eight, and antibodies specific to the omicron variant increased by a factor of eight to 10, Pfizer said.

While the study design and names of researchers conducting the trial are unclear in Pfizers press release, these findings appear to reflect a segment of the population that was the subject of Wednesdays New England Journal of Medicine study.

As vaccine experts await a fuller account of the data cited by Pfizer, they pointed to the newly published Israeli study as evidence that any discussion of second-booster-for-all is premature.

In the U.S., people 12 and older can receive a single booster dose of the Comirnaty vaccine if theyve already completed the two dose Pfizer-BioNTech regimen. Among those who initially got a shot developed by Moderna Inc. or Johnson & Johnson, only those 18 and older can get a Comirnaty booster.

People who received a third dose generally fared better against the delta and omicron variants than people who received only two doses, according to studies the Centers for Disease Control and Prevention released earlier this year.

While COVID-19 cases have dropped sharply from their winter peak, there are signs that another increase in infections could be in the cards in the coming weeks. More than a third of CDC wastewater sample sites in the U.S. showed rising virus trends earlier this month.

Pfizer is also studying an omicron-specific vaccine and a hybrid shot that would target omicron along with earlier variants. The company is expected to report data on these efforts in April.

The CDC recommends some immunocompromised people get a three-dose primary series of mRNA shots and a fourth shot as a booster.

Dr. Paul Offit, an infectious-disease expert at Childrens Hospital of Philadelphia, said that for older and sicker Americans, three shots of vaccine should probably be considered the primary series. The case for a possible fourth shot a booster for these Americans has yet to be made, he added.

In most people, two to three doses or mRNA vaccine have virtually eliminated the threat of an infection progressing to severe disease or death, Offit said. It will be difficult to demonstrate that the immune system needs more vaccine to protect itself against the SARS-CoV-2 virus, he added.

If were going to get past this pandemic, we need to realize that protection against mild illness will not be long-lived, Offit said. Key to that is acknowledging that infections that amount to little more than a sniffle and a cough dont warrant strenuous efforts to prevent. As long as protection against serious illness holds up, we should consider that a win, he said.

--The Associated Press, Bloomberg News and Los Angeles Times contributed to this report

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Heres the latest on possible 4th COVID-19 vaccine shot for Americans - OregonLive