US approves new round of Covid boosters

Agreeing on the continued risk that the coronavirus poses to millions of Americans, the Centers for Disease Control and Prevention said Wednesday that adults over 65 and those with weakened immune systems will undergo a second trial that debuted last fall. It was recommended that the patient receive another dose of the prescribed booster.

The approval came after a day of discussion by CDC expert advisors. The Food and Drug Administration approved the booster plan on Tuesday, and the CDC’s recommendation was the final regulatory step. Eligible Americans can receive booster doses immediately.

Federal health officials are also phasing out the original vaccine formulas created by Pfizer-Biontech and Moderna, revoking their approval in the United States. Instead of requiring two doses, you only need one dose of the reconstituted or “bivalent” Covid shot to be considered vaccinated.

Until now, federal officials had to give recipients two doses of the old vaccine before they could start receiving bivalent boosters.Some experts found the process confusing.

Limited data on reformulated vaccines indicate that shots are extra protection Against severe illness and death from Covid, although protection wanes rapidly in the weeks following vaccination.

is about 53 million According to the Census Bureau, adults over the age of 65 make up about 16% of the population in the United States.and 7 million Americans have weak immune systems due to illness and drugs.

About 250 people in the United States still dead From Covid-related causes every day, the vast majority are over 70 or have compromised immune systems. Only about 43% of adults receive bivalent booster injections.

By this point, most Americans have built immunity to the virus through previous infections, vaccinations, or both. You are protecting yourself and allowing yourself to be protected for free.

Dr. Jeremy Faust, emergency physician and health policy expert at Brigham and Women’s Hospital in Boston, said: “The new regimen recognizes that there is an extraordinary range of Covid risks, from mild to major, depending on who you are.”

Severely immunocompromised people, such as organ transplant recipients, may want to opt for booster shots every six months or even more often, Dr. Faust said.

New guidelines will be announced in the coming weeks UK and Canada Additional shots are recommended for the elderly and those with weakened immune systems. (Britain recommends vaccination only for those aged 75 and over, and Canada only recommends vaccination for those aged 80 and over.)

CDC now says adults over the age of 65 can opt for a booster dose of the bivalent vaccine at least 4 months after the first dose. A person with a weakened immune system may do so two months after his last bivalent dose and may choose to take a higher dose in consultation with his healthcare provider.

At the CDC advisory meeting on Wednesday, Dr. Camille Kotton, a physician at Massachusetts General Hospital, said the new recommendations do not include immunocompromised children between the ages of 6 months and 4 years. Medically vulnerable children, including transplant recipients, are not protected from the virus.

“As mothers and doctors, I feel like this leaves them very vulnerable,” she said in an interview.

For most Americans, the FDA plans to encourage Covid vaccinations each fall, much like the flu shot. Health officials will determine the exact composition of the shots in June based on the version of the virus circulating at the time.

The bivalent vaccine targets the original variant of the coronavirus, as well as variants BA.4 and BA.5 that predominated last summer. However, BA.4 and BA.5 were soon superseded by newer versions.

The latest Omicron subvariant, XBB.1.5currently accounts for about 78% of US cases, and another version, XBB.1.6, accounts for about 7%.So far, reformulated vaccines have prevent aggravation Hospitalization after infection with these variants.

Federal health officials are also making changes to the process for people getting their first injection.

Unvaccinated people receive one dose of the bivalent vaccine instead of multiple doses of the original monovalent vaccine. According to the FDA, most unvaccinated Americans have probably acquired some immunity from previous infections and may not need the first two doses.

Some experts were sharply critical of this advice. According to John Moore, a virologist at Weill Cornell Medical College, the vaccine is most protective when he gets two doses and then he gets one or more boosters to strengthen the shield. A number of data suggest that it is high.

“The FDA has consistently overinterpreted the performance of bivalent formulations when administered as boosters,” said Dr. Moore. “Now it seems we’ve decided beyond science that the first dose has some sort of magical power.”

Deepta Bhattacharya, an immunologist at the University of Arizona, says that almost all unvaccinated adults have already been infected at least once, so it might be reasonable to assume that one dose will do.

“Given the realities on the ground, I think the FDA is just trying to simplify,” he said. But “immunologically, he should be vaccinated twice if it’s the first time.”

The agency could instead recommend two doses of the bivalent vaccine, saying that people with knowledge of previous infections could choose to forgo the second dose, Dr Bhattacharya said. “In practice, I doubt that such a clause would make any material difference,” he added.

“After careful consideration of the available epidemiological evidence, scientific publications, and sponsor-supplied data, the FDA concluded that the single dose of bivalent vaccine offered to individuals previously infected with Covid-19 provided an immune response equivalent to or better than two doses, the original vaccine.”

“The agency believes this approach will help facilitate future vaccinations, especially among those who have not previously chosen to be vaccinated,” the FDA said in a statement.