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.

Bivalent COVID-19 Vaccine Booster

Masks are now optional on public transit, public shelters, and correctional facilities in New York State.

Governor Kathy Hochul announced masking requirements will remain in effect at state-regulated health care facilities, adult care facilities, and clinical settings.

She said the state will continue following COVID-19 data and will adjust policies as needed.

Hochul also announced that the new bivalent COVID-19 vaccine boosters are now available in New York State. These boosters are designed to add Omicron BA.4 and BA.5 variants and bolster previous vaccination protection. The announcement follows the Centers for Disease Control and Prevention‘s recommendation to use updated COVID-19 boosters from Pfizer-BioNTech for anyone age 12 or older and from Moderna for those 18 or older.

To be eligible to receive the updated booster, individuals must have completed their original vaccine series or received a booster at least two months before.

New Yorkers should contact their regular health care provider, local pharmacy, or local county health department about getting the booster. New Yorkers can also visit vaccines.gov, text their ZIP code to 438829, or call 1-800-232-0233 to find nearby vaccination locations.

Hochul said in the coming weeks, the CDC is expected to announce updated COVID-19 boosters for younger pediatric groups. Until then, the monovalent mRNA Pfizer COVID-19 vaccine remains authorized for use as boosters in children ages 5 through 11 and for all primary series vaccinations.

According to the New York State COVID-19 Testing Tracker, Chautauqua County’s seven-day average positivity rate is 12.5%. The CDC Community Level is now at medium. At this level, the CDC recommends wearing a mask if you have symptoms of COVID-19, a positive test, or exposure to someone with COVID. They also recommend wearing a mask on public transportation.

The new shots target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now. This new vaccine is called a bivalent vaccine.

The Moderna COVID-19 vaccine is authorized for use as a single booster dose in people 18 and older.

The Pfizer-BioNTech booster is authorized for people 12 years and up. People are eligible for the new boosters two months after completing their initial vaccination or their last booster shot.

The federal government plans to make the boosters available starting next week. Public health officials hope they will help contain a possible fall and winter surge.

An independent panel of advisers to the U.S. Centers for Disease Control and Prevention voted on Saturday to recommend vaccinating all children in the age group with one of two separate COVID-19 vaccines manufactured by Moderna and Pfizer-BioNTech.

CDC director Dr. Rochelle Walensky quickly endorsed the recommendation, the final step before the vaccines could be rolled out.

During a two-day meeting starting Friday, the panelists reviewed data from clinical trials by both pharmaceutical companies, as well data on the need for vaccines for this age group.

According to the CDC, as of May 28, more than 400 children 0 to 4 years old have died due to COVID.

Dr. Matthew Daley, speaking at the meeting Friday, said, “Among people ages 1-4, COVID is fifth most common cause of all causes of death.”

He said data from older children and adults show that vaccination prevents death. In fact, he added, among people 5 years and older, the unvaccinated are 10 times more likely to die from COVID than the vaccinated.

The vaccine made by Moderna for 6-month-olds to 5-year-olds is a two-dose series, given four weeks apart. The Pfizer-BioNTech vaccine for 6-month-olds to 4-year-olds is a three-dose series. The first two shots are given three weeks apart, and the third one eight weeks after the second shot.

Many providers across the country have already pre-ordered the vaccine and can start administering it as early as this week.

COVID-19 vaccines

The Food and Drug Administration‘s Advisory Committee approved amending the Emergency Use Authorization for the Moderna and Pfizer/BioNTech COVID-19 vaccine to expand to children ages six months through five years old. Next, the Food and Drug Administration will make a final decision on authorization of the vaccine, followed by recommendations made by the Centers for Disease Control and CDC Director, Dr. Rochelle Walensky.

Governor Kathy Hochul released a statement saying once the vaccine is recommended by the CDC Director, the State Department of Health will draft and issue guidance to providers.

Hochul said New York State is already making preparations to boost vaccination rates among children under the age of five with vaccine providers across the state already placing preliminary orders for 39,000 dosages. She added the State Department of Health is working to ensure providers across the state will be able to request additional doses, as well as developing a comprehensive statewide paid media campaign to encourage vaccinations that will launch this summer.

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.

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.”