March 29 – U.S. health officials on Tuesday approved a second COVID-19 booster dose of the two most commonly used COVID-19 vaccines for people age 50 and older, citing data showing declining immunity and the risks emanating from omicron variants of the vaccine Virus.
The US Food and Drug Administration said the new boosters – a fourth round of vaccinations for most vaccine recipients – of vaccines from Pfizer Inc (PFE.N)/BioNTech SE (22UAy.DE) and Moderna Inc (MRNA.O) should be administered at least four months after the previous dose. They should offer more protection against serious illnesses and hospital stays.
The FDA also approved a second booster shot of the vaccines for younger people with compromised immune systems — those 12 and older for the Pfizer/BioNTech vaccine and 18 and older for Moderna.
The U.S. Centers for Disease Control and Prevention (CDC) supported the FDA’s approval and recommended the supplemental vaccination, particularly for the elderly and those with underlying medical conditions that put them at higher risk.
The decision to offer second booster shots in the United States comes as some scientists have raised concerns about the highly contagious and recently prevalent BA.2 omicron subvariant that has led to COVID-19 cases in other countries.
“If it were my relatives, I would send them to it,” said FDA chief official Dr. Peter Marks during a press conference on booster vaccinations. “COVID-19 has had a truly disproportionate adverse effect on people aged 65 and over and on people with comorbidities.”
COVID cases in the United States have fallen sharply since a record spike in January, but have seen a slight increase over the past week, according to CDC data.
WIDER BOOSTER CAMPAIGN MAY BE NEEDED
Marks said the FDA will soon consider the benefits of approving another round of boosters — perhaps specifically to target new variants of concern — for a broader population after the summer.
A nurse refills syringes for patients as they receive their booster shots against coronavirus disease (COVID-19) during a Pfizer-BioNTech immunization clinic in Southfield, Michigan, September 29, 2021. REUTERS/Emily Elconin
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“People may need to get an additional booster along with a more general booster campaign in the fall if that happens, as we may need to switch to a different coverage variant,” he said.
The FDA said it looked at data from a relatively small, ongoing clinical trial in Israel to make its decision. In addition, safety data from more than 700,000 people who received second booster shots in Israel did not reveal any new concerns, the agency said.
Scientists and officials have debated for months if and when an additional booster shot would be needed while analyzing data on how long protection from the vaccines and boosters would last. Continue reading
“It’s not clear if now is the right time for people to get a fourth dose,” said Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.
If there’s a spike in cases in late fall or early winter, which is typical of respiratory viruses and influenza, an extra boost may be needed, he said. The body’s neutralizing antibodies, which are being spurred on by a fourth booster shot now being given, could begin to wane in just a few months, he said.
It is also unclear whether young, healthy people need a fourth vaccination. The study of Israeli medical workers cited by the FDA suggested that the fourth dose added little additional protection in the age group.
Biden administration officials have said the US government currently has enough doses of the vaccines to meet demand for another round of booster shots among older Americans, even as funding for the US pandemic response is so good how exhausted.
They say the government likely won’t be able to pay for future vaccines when they’re needed unless Congress authorizes more spending, especially if vaccines have to be redesigned to target new variants.
About two-thirds of fully vaccinated Americans over the age of 65 and just over half of people between the ages of 50 and 64 have received their first booster shot to date.
Reporting by Michael Erman in New Jersey, Manojna Maddipatla and Leroy Leo in Bengaluru, Additional reporting by Ahmed Aboulenein in Washington; Edited by Bill Berkrot