FDA approves vaccine boosters

Published 7:40 pm Friday, October 22, 2021

The Food and Drug Administration has authorized booster shots for COVID-19 in certain groups following the Centers for Disease Control and Prevention’s recommendation, and will allow people to mix and match them regardless of which one they initially received.

For people who have received two doses of the Pfizer-BioNTech or Moderna vaccine, the following groups of people are eligible to receive a booster after at least six months: those age 65 and up and those 18 and up who live in long-term care settings, have underlying medical conditions or who work or live in high-risk settings.

Moderna’s booster dose will be half of the regular dose for adults, with company officials saying it induced “a strong immune response.” Officials said they chose a smaller dose because it didn’t induce as many shot reactions such as fever or achiness, and because it leaves more vaccine to help with the global supply.

For people who received the Johnson & Johnson vaccine, booster shots are recommended for those 18 and up who were vaccinated at least two months ago. The CDC is expected to give further guidance in the next several days to help people understand the recommendations.

The Virginia Department of Health said Virginia residents are now able, as of Oct. 21, to receive boosters for Moderna and Johnson & Johnson vaccines.

The FDA approval also allows for people to mix-and-match vaccines. Regardless of which vaccine people received, they can receive a Pfizer, Moderna or Johnson & Johnson booster.

“These recommendations are another example of our fundamental commitment to protect as many people as possible from COVID-19,” CDC director Dr. Rochelle P. Walensky said in a statement. “The evidence shows that all three COVID-19 vaccines authorized in the United States are safe — as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant.”

The CDC says available data shows all three COVID-19 vaccines approved or authorized in the United States are highly effective in reducing the chances of severe disease, hospitalization and death, even against the Delta variant.

The agency is still urging the more than 65 million unvaccinated in the U.S. to get a COVID-19 vaccine.

In Virginia, more than 69% of residents have received at least one dose of a COVID-19 vaccine, and more than 62% are fully vaccinated. Among adults over 18, more than 82% have received one dose and 74% are fully vaccinated.

Among those living in the Western Tidewater Health District’s localities of Suffolk, Franklin, Southampton County and Isle of Wight, as well as Surry County in the Crater Health District, one-dose vaccination rates range from 53% to just over 62%. In the same area, those who are fully vaccinated range from just over 45% to more than 55%. Among adults over 18, one dose vaccination rates range from nearly 62% to over 77%, and the rates among those fully vaccinated go from about 53% to just over 67%. Booster/third dose rates in the region range from 1.3% to 3.2%.

State vaccine liaison Dr. Danny Avula said the vaccines are available across the state. He said the CDC’s recommendation to allow for mixing and matching of vaccines for booster shots gives residents “another level of choice” in helping protect against COVID-19. He urges people who are going to get a different booster vaccine than the one they initially received to consult their doctor or healthcare provider to help people make the best choice for their own situation, though he stressed that all three vaccines authorized in the U.S. are safe and highly effective at preventing severe illness, hospitalization or death should they still get COVID-19.

“VDH has been working with our vaccination partners — pharmacies, healthcare providers, hospitals and other institutions — to prepare for the booster rollout,” Avula said in a statement.
“In addition to these vaccination partners, community vaccination centers are strategically located across the Commonwealth to ensure Virginians will be able to access a booster dose when it’s recommended.”

Age 5-11 vaccine on verge of emergency use authorization

Currently, everyone 12 and up can be vaccinated, but the FDA is on the verge of approving an emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccines for children ages 5 to 11.

They reported Oct. 21 that their vaccine for that age group is nearly 91% effective. The trial had 2,268 participants — 1,518 who received the vaccine and 750 who got a placebo, with a follow-up time of at least two months after the second dose.

Trial participants receiving the vaccine received two 10-microgram doses spaced three weeks apart. That dosage is a third of what adults receive and was done to minimize side effects, but they still got a strong immune response.

The Pfizer-BioNTech trial did not observe any cases of myocarditis or pericarditis in the three months following the second dose, but it noted the number of participants in the trial was too small to detect risks.

The FDA’s advisory committee will review the findings Oct. 26.

Pending emergency use authorization, the White House has announced plans to get vaccines out to that age group beginning in early November.

Jeff Zients, the White House coronavirus response coordinator, said more than 25,000 pediatricians, family doctors and other primary care providers have been enrolled to administer vaccines, and it is working with states and localities to enroll more.

As part of the federal pharmacy program, pharmacies across the country will also be vaccinating kids, along with hundreds of community and rural health centers, primarily in underserved communities.

The White House is also working with the Children’s Hospital Association to partner with more than 100 children’s hospitals across the country to set up vaccination sites in their communities, including ones on evenings and weekends to allow families to get their kids vaccinated at convenient times for them.

It also plans to have vaccination clinics at schools, matching pharmacies and other vaccine providers with school divisions for on-site clinics, and Zients said equity and fairness will be at the center of its youth vaccination program.

“By sending vaccines to pediatricians, pharmacies, community health centers, and rural health centers; working with children’s hospitals to host vaccination sites, including on nights and weekends; helping schools stand up vaccination clinics; and deploying mobile clinics to meet families where they are,” Zients said during an Oct. 20 briefing, “we will ensure that vaccinations for kids ages 5 through 11 are easy, convenient, and accessible to every family.”