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.

The authorization makes all children in that age group who received their second shot at least five months ago eligible to receive a third shot of the Pfizer-BioNTech vaccine.

The companies requested the authorization based on a small study that the companies and FDA said demonstrated a third shot is safe and can significantly boost antibody levels, countering waning immunity and providing added protection against the virus, including the more contagious omicron variant.

Until now, only children ages 12 and older and adults were eligible for a booster.

It remains unclear how much of a demand there will be for the boosters. Less than a third of children ages 5 to 11 are fully vaccinated, and only about a quarter of adolescents have received a booster.

Many doctors and parents have been hoping for the authorization, saying it’s important to provide children with as much protection as possible, especially as the number of people catching the virus is rising again and so few people are now wearing masks.

The FDA didn’t ask its outside advisers for input on the decision because the agency said the committee had previously discussed the issues and no new questions were raised.

The Centers for Disease Control and Prevention‘s advisers on vaccine practices will meet Thursday and are expected to discuss implementation of a booster dose for this age group.

Governor Kathy Hochul gives COVID-19 report in Syracuse (April 20, 2022)

NPR reports the U.S. Justice Department is appealing the ruling by a federal judge that voided the mask mandate for public transportation.

DOJ spokesperson Anthony Coley said a notice of appeal had been filed in light of the determination by Centers for Disease Control and Prevention that wearing a mask “remains necessary to protect the public health.”

The CDC said it had asked the DOJ to appeal. The public health agency continues to recommend that people wear masks in all indoor public transportation settings and says “wearing masks is most beneficial in crowded or poorly ventilated locations, such as the transportation corridor.”

The Biden administration had previously insinuated that it might appeal the ruling by U.S. District Judge Kathryn Kimball Mizelle after checking with the CDC.

The department’s decision to appeal comes just two days after Mizelle ruled that the CDC had exceeded its authority and had failed to follow proper rule-making procedures.

After the judge’s ruling on Monday, many airlines ditched their requirements for passengers to wear masks while traveling.

New York state will still require masks on public transportation despite the ruling by Mizelle.

Governor Kathy Hochul made that announcement in a press conference in Syracuse, saying that because of omicron subvariants and rising cases in the state, it is necessary to maintain a mask mandate for buses and bus stations, trains and train stations, subways and subway stations and airports.

Masks will also be required in the following locations:
– State-regulated health care settings
– State-regulated adult care facilities and nursing homes
– Correctional facilities
– Homeless shelters
– Domestic violence shelters

According to Hochul, cases of COVID-19 are on the rise with an average of 40 cases per 100,000 people. She says there are around 1,400 people currently hospitalized with the virus across the state.
Despite the increase, the governor says the current cases are nowhere near where they were in January and she does not expect the current spike to reach that level.

In Chautauqua County, the County Health Department‘s weekly report for April 20 shows one person hospitalized and an increase in the 7-day average positivity rate to 3.8% from last week’s rate of 1.2%.

Wastewater monitoring levels in Jamestown and Dunkirk both remain unchanged from the previous week and reflect low levels of COVID-19.

COVID Wastewater Surveillance for April 5, 2022

The Federal transportation mask mandate is being extended for another 15 days.

CNN reports individuals traveling aboard airplanes, trains and on public transportation in the United States will be required to wear a mask until at least early May.

The mandate is now set to expire on May 3. The U.S. Centers for Disease Control and Prevention announced Wednesday that it was keeping its mask order in effect, and the Transportation Security Administration announced it was extending the mandate for an additional 15 days.

TSA said in a statement, “CDC continues to monitor the spread of the Omicron COVID-19 variant, especially the BA.2 subvariant that now makes up more than 85% of US cases. Since early April 2022, there have been increases in the 7-day moving average of COVID-19 cases in the United States.”

In its own statement, the CDC said, “In order to assess the potential impact the rise of cases has on severe disease, including hospitalizations and deaths, and health care system capacity, the CDC Order will remain in place at this time.”

According to the latest estimates from the CDC, BA.2 caused 86% of new COVID-19 cases nationwide last week.

In Chautauqua County, the County Health Department reports the seven day average positivity rate at 1.2% with the CDC level of “low” for the week of April 3 through 9. The wastewater surveillance testing results in Dunkirk and for Jamestown show a decline in the amount of COVID-19 in samples taken on April 5.

We’ll be discussing more about how COVID-19 has affected Healthcare over the last two years on this month’s Community Conversation at 6pm on WRFA.

The FDA’s decision opens a fourth dose of the Pfizer or Moderna vaccines to that age group at least four months after their previous booster.

Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.

The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans. The Centers for Disease Control and Prevention is expected to weigh in.

The move comes at a time of great uncertainty. COVID-19 cases have dropped to low levels after the winter surge of the super-contagious omicron variant. CDC data shows that two vaccine doses plus a booster still provide strong protection against severe disease and death.

But an omicron sibling is causing a worrisome jump in infections in Europe, and spreading in the U.S., even as vaccination has stalled. About two-thirds of Americans are fully vaccinated, and half of those eligible for a first booster haven’t gotten one.

Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults “to provide flexibility” for the government to decide who really needs one.

The FDA set age 50 as the threshold for both companies. As for the immune-compromised, only the Pfizer vaccine can be used in those as young as 12; Moderna’s is for adults.

There’s limited evidence to tell how much benefit another booster could offer right now. FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots.

The newest booster expansion may not be the last: Next week, the government will hold a public meeting to debate if everyone eventually needs a fourth dose, possibly in the fall, of the original vaccine or an updated shot.

CDC: COVID-19

The San Francisco Chronicle is reporting that while the Omicron variant is still highly contagious, experts don’t think it’s inevitable that everyone will get COVID at some point.

The Centers for Disease Control and Prevention recently estimated that around 43% of people in the U.S., or about 140 million people, have been infected with the coronavirus, which leaves almost 60% never having had it. The estimate counts each person once, so some of the more than 140 million Americans estimated to have had COVID may have been infected more than once.

University of California in San Francisco Chair of Medicine Dr. Bob Wachter said when case rates are low, those who have not had COVID are unlikely to get it “since they won’t be exposed very much.”
Those who are vaccinated and boosted, he added, “will remain relatively protected even if they do get exposed.”

Experts also said there are benefits to avoiding infection for now, even if it’s possible you contract the coronavirus later. They said the longer the pandemic goes on, the more we understand about the virus, which means that treatments are likely to be better and more accessible.

While there are no guarantees in a pandemic, experts said, the most important thing is for people to start finding ways to return to life while staying flexible as the virus continues to fluctuate.

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.