CDC Has Approved a New Round of Covid Boosters for Vulnerable Populations
The government has given the green light for a second COVID booster shot for older people and others with impaired immune systems. The bivalent booster injection specifically targets the omicron varieties. The revised booster may be given to seniors 65 and above four months after the first dosage.
In acknowledgment of the continued threat that the coronavirus poses to millions of Americans, the Centers for Disease Control and Prevention (C.D.C.) suggested on Wednesday that people 65 and older and those with weaker immune systems get another dose of the reformulated booster launched last fall.
The recommendation came after a daylong debate among the C.D.C.'s advisory panel. On Tuesday, the Food and Drug Administration approved the booster plan, and the last administrative step was the recommendation from the C.D.C. Those Americans who qualify for booster shots may get them right now.
The initial vaccine formulations that Pfizer-BioNTech and Moderna developed are likewise being phased out by federal health regulators, who are subsequently losing their authorizations in the United States. Unvaccinated persons will now only need a single dose of the reformulated, or "bivalent," Covid injection in order to be deemed vaccinated. This is a significant change from the previous requirement, which called for an initial series of two doses.
Before this change was made, government authorities needed patients to have had two doses of the older vaccination before they could begin to get the bivalent boosters. Some industry professionals found this procedure to be unclear.
Although the protection declines fast in the weeks after vaccination, the few data available on the reformulated vaccinations suggest that the injections give greater protection against severe illness and mortality caused by COVID in older persons. However, this protection is not permanent.
According to data provided by the Census Bureau, around 53 million individuals in the United States are 65 or older, making up approximately 16 percent of the total population. And seven million people in the United States have immune systems compromised due to sickness or the use of drugs.
There are currently around 250 deaths per day in the United States that may be attributed to factors connected to COVID. The great majority of those affected are over the age of 70 or have immune systems that are compromised. According to the Centers for Disease Control and Prevention, the average age of patients in hospitals is 75 years old. Nevertheless, as of this point, only around 43 percent of persons aged 65 and older had gotten a bivalent booster dose.
The vast majority of Americans have developed some level of immunity to the virus, either as a result of previous infections, immunizations, or a combination of the two. The revised recommendations recognize this fact, but they also make it possible for those who are still at a high risk of contracting the virus to protect themselves without incurring any costs for doing so.
"The one-size-fits-all policy was simple, but it was not optimal," said Dr. Jeremy Faust, an emergency care physician and a health policy specialist at Brigham and Women's Hospital in Boston. "The policy was not optimal, but it was simple." "The new regimen recognizes that there is now an extraordinary spectrum of Covid risk, ranging from minimal to substantial depending on the individual."
According to Dr. Faust, people with chronic immunosuppression, such as organ transplant recipients, may choose to receive supplemental injections every six months or more frequently.
The new recommendations come weeks after the United Kingdom and Canada recommended additional vaccinations for seniors and immunocompromised individuals. (Britain recommended the vaccinations for those 75 and older, while Canada only recommended them for those 80 and older.)
The C.D.C. now states that adults aged 65 and older may choose to receive a second dose of the bivalent vaccine at least four months after their initial injection. Those with compromised immune systems may choose to receive additional doses in consultation with their healthcare provider two months after their last bivalent dose.
Dr. Camille Kotton, a physician at Massachusetts General Hospital, stated at the C.D.C. advisory meeting on Wednesday that the new recommendations did not include immunocompromised children ages 6 months to 4 years. She explained that this leaves these medically fragile children, including organ transplant recipients, unprotected against the infection.
In an interview, she stated, "As a mother and a physician, I believe we are leaving them so vulnerable."
The F.D.A. intends to encourage annual Covid vaccinations in the autumn for the majority of Americans, as it does with flu vaccines. In June, health officials will determine the vaccine's precise composition based on the virus's circulating strain.
The bivalent vaccine targets not only the original variant of the coronavirus but also the variants BA.4 and BA.5, which were prevalent last summer. However, more recent versions soon replaced BA.4 and BA.5.
The most recent Omicron subvariant, XBB.1.5, accounts for approximately 78 percent of cases in the United States, while XBB.1.6 accounts for approximately 7 percent. The reformulated vaccines prevent hospitalization and severe illness following infection with these variants.
In addition, federal health officials are modifying the initial vaccination procedure.
Instead of receiving multiple doses of the original monovalent vaccine, unvaccinated individuals will receive a single dose of the bivalent vaccine. According to the F.D.A., the rationale is that the majority of unvaccinated Americans likely have immunity from a previous infection and may not require two dosages initially.
Some experts were extremely critical of the recommendation. According to John Moore, a Weill Cornell Medical College virologist, mountains of evidence indicate that the vaccines are most effective when administered in two doses, followed by one or more supplements to strengthen the protection.
"F.D.A. has consistently overestimated the effectiveness of the bivalent formulation when administered as a booster," Dr. Moore stated. "At this point, it appears to have transcended science and decided that its initial dose possesses some magical power."
According to immunologist Deepta Bhattacharya of the University of Arizona, it may be reasonable to presume that nearly all unvaccinated adults have been infected at least once and can get by with a single dose.
Given the actuality on the ground, he stated that the FDA is simply attempting to clarify. However, "from an immunological standpoint, you should get two shots if it's your first exposure."
Dr. Bhattacharya suggested that the agency could instead recommend two doses of a bivalent vaccine, with the option to postpone the second dose for those with a history of infection. However, he added, "I doubt that such a clause would make a significant difference in practice."
The F.D.A. stated that it had "carefully reviewed the available epidemiologic evidence, scientific publications, and sponsor data indicating that a single bivalent vaccine dose administered to individuals previously infected with Covid-19 provides an immune response equal to or greater than two doses of the original vaccine."
In a statement, the F.D.A. said, "The agency believes this approach will help encourage future vaccination, especially among those who have not been vaccinated to date."