Bivalent COVID-19 Vaccine Booster

The Centers for Disease Control and Prevention has recommended the new omicron boosters for kids as young as age 5.

CDC Director Dr. Rochelle Walensky signed off on the shots Wednesday, just hours after the Food and Drug Administration authorized them. Walensky made the swift decision without a meeting of the CDC’s independent panel of vaccine experts.

Children ages 5 to 11 are eligible for Pfizer’s omicron shots and kids ages 6 through 17 are eligible for Moderna’s shots two months after receiving their primary series or previous booster with the first generation vaccines.

Pharmacies can start administering the shots as soon they have doses. According to a company statement, Pfizer said it will ship to up 6 million booster doses for kids within the next week.

Pfizer’s new boosters were cleared for people ages 12 and up in September, while Moderna’s were authorized for adults ages 18 and older.

The FDA hopes the new boosters, which target the dominant omicron BA.5 subvariant, will provide substantially better protection against infection and disease compared to the first generation of Covid shots.

The FDA authorized the BA.5 shots for kids without direct human data on their effectiveness. The agency cleared the boosters based on adult data from a similar shot that targets the omicron BA.1 subvariant.

The agency also looked at clinical studies in kids who received the original vaccines as boosters.

The new boosters target omicron BA.5 as well as the original strain of Covid that first emerged in Wuhan, China, in 2019. The FDA hopes the shots will provide durable protection even as the virus continues to evolve because they cover a broad range of mutations.

The first generation of Covid shots were developed in 2020 to target the original strain of Covid. They are no longer providing meaningful protection against infection and mild illness because they do not match the dominant omicron variant, which has mutated to evade the antibodies that block the virus from invading human cells.

According to CDC data, more than 11 million Americans ages 12 and older have received the new booster shots so far.

Bivalent COVID-19 Vaccine Booster

The new bivalent COVID-19 vaccine booster is now available in Chautauqua County.

Chautauqua County Public Health Director Christine Schuyler issued a statement saying booster doses are common for many vaccines and that updated formulations are sometimes needed to provide the best protection against new variants of a virus.

The updated bivalent COVID-19 vaccine booster approved by the U.S. Food and Drug Administration and recommended by the CDC is designed to protect against original strains of the virus, which the former monovalent vaccines covered, and the Omicron variants that account for the majority of current new infections.

Schuyler said those who are eligible should get a new booster dose at least two months after completing their primary series or at least two months after receiving a booster. Pfizer’s updated booster dose is recommended for individuals 12 and older and Moderna’s updated booster dose is recommended for adults 18 and older.

The link for pharmacies offering the booster dose is available here:
https://chqgov.com/public-health/novel-coronavirus-covid-19

The Health Department is also offering bivalent Pfizer COVID-19 vaccine to individuals ages 12 and older at the Health Department Office in Mayville, Monday through Friday from 9 a.m. to 4 p.m. You are asked to call (716) 753-4491 to schedule an appointment.

Moderna

CNN reports no COVID-19 vaccines have been authorized for children younger than 5 in the US — about 18 million people — and a timeline to potential authorization is not yet clear. Moderna officials have said the FDA is expected to move fast, and a Pfizer official suggested its vaccine for younger children could be available in June, if it’s authorized.

FDA’s Center for Biologics Evaluation and Research Director Dr. Peter Marks called vaccines for younger children “one of our highest priorities,” but acknowledged the agency needed complete applications from vaccine manufacturers in order to finish its review.

The FDA will ask its independent vaccine advisers to weigh in on vaccines for younger children, too, and Marks said the agency would release a timeline for advisory committee meetings in the next week.

Pfizer

ABC News reports the move puts the process in motion for the FDA to review the data, bring it before its independent advisers and potentially authorize the vaccine in the coming weeks. The FDA independent advisers are already slated to have a public hearing on February 15.

The data would then be brought before the Centers for Disease Control and Prevention‘s independent advisers for another review, and finally, a potential recommendation by CDC Director Rochelle Walensky — all potentially within the month.

As of now, Pfizer’s two-dose vaccine is available to anyone over 5 years old. A booster shot after five months is available to anyone over 12 years old. Moderna and Johnson & Johnson are available to adults.

Pfizer announced it had safety and efficacy for its vaccine for kids under 5 in December, but determined that the two-dose regimen wasn’t as effective for children 2, 3 and 4 years-old as it was for adults. The dose for kids under 5 is one-tenth the dose for adults.

On Tuesday, Pfizer again submitted data on two doses of the vaccine, but with the expectation that data will soon be available to make it a three-dose vaccine, which will likely be more effective at preventing illness.

Pfizer is expected to have more information on the efficacy of a three-dose regimen in March or April, but authorizing the first two doses in February would start the immunization process earlier.

The third dose would be given at least eight weeks after the second dose.

Some parents of young kids have been desperate for a shot to be authorized so they can protect their children against severe disease. Kids under the age of 5 have now spent nearly half of their lives in the pandemic, and for many parents their unvaccinated status has been a huge stressor.

A weekly report by the American Academy of Pediatrics and the Children’s Hospital Association said about 808,000 children tested positive for COVID-19 last week, which is down from the peak level of 1,150,000 reported the week ending January 20.

However, the organizations warn that pediatric infections remain “extremely high,” still triple the peak level of the summer delta surge in 2021.

A total of 11.4 million children have tested positive for the virus since the onset of the pandemic. Child COVID-19 cases have “spiked dramatically” during the omicron variant surge, with more than 3.5 million child cases reported in January.

Still, because kids are less likely to get seriously sick from COVID-19, many parents have opted not to vaccinate them even when they become eligible.

Nearly 70% of eligible kids ages 5 to 11 have yet to get a shot, according to a January survey from KFF, a nonpartisan health nonprofit. It’s unclear how many parents will opt to vaccinate their children under 5, when the vaccine becomes available.

But experts point to many reasons to get children vaccinated, including their own health and the health of the community around them.

According to the CDC, unvaccinated 12 to 17-year-olds had an 11 times higher risk of hospitalization than fully vaccinated adolescents.

And while young kids are less likely to end up in the hospital, it’s still possible. They can also be vectors for spread, infecting other, higher-risk adults in their community.

Both the delta and omicron surges saw full pediatric wards in hospitals, often with doctors pleading for communities to increase their vaccination rates.

December 2, 2020 – Albany, NY – Governor Andrew M. Cuomo provides a coronavirus update during a press conference in the Red Room at the State Capitol. (Mike Groll/Office of Governor Andrew M. Cuomo)

ALBANY – Governor Andrew Cuomo announced Wednesday that New York will receive 170,000 COVID-19 vaccine doses by Dec. 15.

Cuomo said that the vaccines will be distributed once they are approved by the FDA and then reviewed by a state panel. He said the 170,000 is based on the CDC reporting that a limited number of vaccinations will be distributed in each state and it will be based on the percentage of a state’s population to the overall population of the country.

That first batch of 170,000 vaccines will be those manufactured by Pfizer, Cuomo said, and another batch of a yet-unknown size is expected two weeks later from Moderna, another pharmaceutical company.

By the end of the month, 20 million people are expected to be vaccinated nationally — about 6 percent of the country’s population.

The Food and Drug Administration has a critical meeting next Thursday to authorize emergency use.

Cuomo said if approval is granted, the first doses will go to nursing home residents and health care workers.

He also said that people are skeptical of any vaccine that is rushed for approval by the FDA, which is why he’s calling on a state panel to also review any vaccine prior to being distributed in New York.

“The New York panel will review the FDA’s approval. Why? Because we know we have existing skepticism about the vaccine. Our panel did not create the skepticism. The skepticism existed and that’s why we created the review panel,” Cuomo said. “The Kaiser poll says 60 percent of Americans are skeptical about the vaccine approval process. Kaiser is not a political organization. Pew poll says about 50 percent of Americans are skeptical about the vaccine. That is very, very troubling. If people think the vaccine approval process was politicized, they’re going to be less likely to take the vaccine.”

The governor also cited experts who say the “normal economy” will return when between 75 and 85 percent of the population is vaccinated. But that process, he said, will likely take until June or September depending on the efficiency of the distribution process, which he described as the “largest governmental operation undertaken since World War II.”

The FDA has a critical meeting next Thursday to authorize emergency use.

Meanwhile, the governor is continuing to tell residents to do what they can to mitigate spread and avoid overwhelming healthcare facilities.

“The biggest fear is overwhelming the hospitals, period. That’s where we are and that is a serious, serious concern,” Cuomo said. “We know the capacity of hospitals – 54,000 statewide. We know it by region. Manage that load. Increase and balance the testing. There is a lot of demands on testing. You have to test nursing homes, you have to test essential workers, you have to test business professionals who have licenses, who have to be tested as part of their work. You want to be fair in balancing that testing.”

The governor also indicated that it is up to every resident to work to slow the spread and urged them to follow the advice of health experts and also his executive order guidelines.

“My personal opinion is that you’re going to see the increase continue all through the holidays. You’ll see it continue through January 2 and then the lag for the testing and hospitalization which takes you to about mid-January. The question is, how fast do the cases increase? Nobody can tell you because it depends on what people do. It is up to us. There is no pre-determined fate. It is a pure function of what New Yorkers do. It’s a pure function of social action,” the governor said. “What can government do during this period? We can warn people. We can educate people. We can enforce restrictions. We can do testing and tracing.”