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Health and Lifestyle, Local, National

Updated: FDA and CDC approve COVID vaccination boosters for all adults

Update: CDC Director Rochelle Walensky granted final approval to the FDA amendments of the Pfizer and Moderna EUAs.

[WASHINGTON, D.C.] – (MTN) The U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for the Moderna and Pfizer-BioNTech Covid-19 vaccines authorizing a single booster dose for all individuals 18 and older six months after receiving their second dose. Shortly after, the Centers for Disease Control panel of vaccine scientists unanimously endorsed the FDA’s authorization. CDC Director Rochelle Walensky needs to provide final approval, but that is expected to happen on Friday.

Pfizer requested the Emergency Use Authorization (EUA) for its Covid-19 vaccine to be amended to include booster doses for all adults on November 9 and Moderna made an identical request on November 17. Previously, only adults 65 and over, and people 18 to 64 with certain medical conditions, work in specific jobs, or live in communal areas were authorized to get a booster if they had received an mRNA vaccine from either company.

3.3 million Washington state residents 16 and older were fully vaccinated on May 30, according to the Washington State Department of Health (DOH). By the end of November, almost every person in that group will be eligible for a booster after Walensky gives her approval.

Almost all of these people would be eligible for a booster shot. Despite the mounting evidence that immunity wanes after five to seven months, only 675,000 residents have received boosters through November 7.

Data out of Israel, the United Kingdom, and Germany indicate that the United States is woefully unprepared for a sixth wave. Israel authorized boosters for older residents in July at the beginning of its fifth wave and expanded the program to include everyone 12 and older in September. That program was instrumental in ending the fifth wave.

For 9.2 million Israelis, COVID is now endemic. The government took a unified approach, enabling local councils within individual communities to determine if their city was green, yellow, or red. Almost all of Isreal is in a “green life category.” Masks aren’t required and life, travel, business, and entertainment are normal. Israel has a similar vaccination rate to the United States but a much larger number of people who received boosters.

Multiple studies have shown that infection acquired immunity and vaccine immunity are strong for five to seven months and then start to wane. In December 2020 health officials set expectations that it was unknown how long immunity would last, and many indicated that future booster shots would be likely. Anti-vaccination advocates and disinformation campaigns have used waning immunity as a talking point to sow distrust in vaccination programs.

Last month, the FDA and CDC approved booster shots for anyone 18 and older that received the viral-vector Johnson & Johnson vaccine.

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2.6 million Washingtonians in need of Covid boosters as FDA mulls expanding eligibility

[WASHINGTON, D.C.] – (MTN) The US Food and Drug Administration confirmed that the Vaccines and Related Biological Products Advisory Committee will meet to consider authorizing Pfizer vaccine Covid-19 boosters for all this week.

Pfizer requested the Emergency Use Authorization (EUA) for its Covid-19 vaccine to be amended to include booster doses for all adults 18 and older regardless of comorbidities, vocation, or living situation on November 9. Currently, only adults 65 and over, and people 18 to 64 with certain medical conditions, work in specific jobs, or live in communal areas are authorized to get a booster.

Dr. Peter Marks, director of the FDA’S Center for Biologics Evaluation and Research, told CNN the EUA amendment request was the center’s “highest priority.”

3.3 million Washington state residents 16 and older were fully vaccinated on May 30, according to the Washington State Department of Health (DOH). Under the updated guidelines, almost all of these people would be eligible for a booster shot. Despite the mounting evidence that immunity wanes after five to seven months, only 675,000 residents have received boosters and the DOH told Malcontent News last week the state would not deviate from current federal guidelines.

A growing list of states isn’t waiting for the federal government. Arkansas, California, Colorado, Kansas, Minnesota, New Jersey, New Mexico, and West Virginia have issued guidance or directives for anyone who received their second dose of mRNA vaccine more than six months ago to get a booster shot within the last week.

Sunday on Face the Nation, Colorado governor Jared Polis expressed frustration on information coming from the FDA and CDC on boosters.

“I’ve been very frustrated with the convoluted messaging out of the CDC and the FDA. Everybody should get the booster after six months. The data is incredibly clear that it increases your personal protection level. That’s why my parents got it. I got it. My family members got it.”

Yesterday, speaking at the Reuters Total Health Conference, Dr. Anthony Fauci of the National Institutes of Health (NIH) called for the United States to authorize boosters for all.

“To me, if you want to get to endemic, you have got to get the level of infection so low that it does not have an impact on society, on your life, on your economy,” Fauci said. “People will still get infected. People might still get hospitalized, but the level would be so low that we don’t think about it all the time and it doesn’t influence what we do.”

“To get there,” he said, “would take a lot more people rolling up their sleeves for initial COVID-19 shots and boosters.”

The FDA is widely expected to approve Pfizer’s request but the authorization will require approval by the Centers for Disease Control and must be signed off by CDC Director Dr. Rochelle Walensky to become official policy.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will hold an emergency meeting on Friday to discuss Pfizer’s request.

Data out of Israel, the United Kingdom, and Germany indicate that the United States is woefully unprepared for a sixth wave. In Germany where cases are exploding only 3% of the population has received booster shots. Most cases continue to be among the unvaccinated in low-vaccinated regions.

Israel authorized boosters for older residents in July at the beginning of its fifth wave and expanded the program to include everyone 12 and older in September. That program was instrumental in ending the fifth wave where life has largely returned to normal. Despite the surge in cases, hospitalizations and deaths were significantly blunted compared to the winter of 2020.

Germany and Israel have similar vaccination rates to the United States and the Delta variant has repeatedly moved through areas with low-vaccinated populations as seasonal changes move people indoors. COVID cases are increasing in 31 U.S. states with Colorado, Minnesota, Wisconsin, Pennsylvania, and Maine are dealing with significant surges.

Multiple studies have shown that infection acquired immunity and vaccine immunity are strong for five to seven months and then start to wane. In December 2020 health officials set expectations that it was unknown how long immunity would last, and many indicated that future booster shots would be likely. Anti-vaccination advocates and disinformation campaigns have used waning immunity as a talking point to sow distrust in vaccination programs.

Moderna has not applied with the FDA to amend the EUA for its vaccine and the FDA did not indicate it would be including Moderna in the discussions. Mixing and matching of COVID boosters were approved on October 21, but there is no indication if boosters for all are approved by the FDA and CDC, that mix and match rules will extend to recipients of the Moderna vaccine.

You can read our special report, Who is eligible for a COVID-19 booster and why should get one now, to learn if you are currently eligible.

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Exclusive: California and Colorado break with the Western States Pact over COVID boosters

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[OLYMPIA] – (MTN) California governor Gavin Newsom and Colorado governor Jared Polis issued directives last week instructing healthcare providers to allow booster shots to anyone 18 and older, breaking from federal guidelines and forging a different path from the Western States Pact.

In April 2020, California, Oregon, and Washington entered into an agreement that would align the COVID response between the three states. Two weeks later Nevada and Colorado joined the pact. A similar agreement was reached on the East Coast, including many New England and Mid-Atlantic states. The cooperative agreements were created to share research and education telecommunications networks and services to align the regional response.

The states have largely been in agreement for the last 19 months so the recent fracture on booster protocols is a new development. After Colorado announced their directive on Tuesday, Charlie Boisner, the COVID-19 Public Information Officer for the Washington State Department of Health, told Malcontent News in an e-mail, “DOH is following guidance from the FDA, CDC and Western States as to whom is eligible to receive a booster shot. Additional populations may be recommended to receive a booster as more data becomes available. Washington has no plans of implementing measures outside of current authorizations.”

In a follow-up after California announced they were also breaking from FDA and CDC guidance and issuing a directive for “boosters for all,” Boisner responded, “Washington has no plans of implementing measures outside of current authorizations.”

Several Western Washington hospitals are dealing with a significant number of breakthrough cases among staff that were vaccinated in January and February.

On Monday morning New Mexico, also dealing with a late fifth wave surge, and New York City issued directives to make Covid-19 booster shots eligible for anyone 18 and over who wants one.

Colorado is facing a late fifth wave, with hospitals operating at crisis standards of care and projections indicating the state will run out of hospital resources by Christmas. Cases are also up in California with the surges in both states largely driven by the unvaccinated. Within the data, there is growing evidence that vaccines and natural immunity are waning. Among the unvaccinated reinfections are increasing dramatically and among the vaccinated, breakthrough cases among those vaccinated more than six months ago are creeping upward.

Last week Dr. Anthony Fauci urged anyone eligible to receive a booster to get one as soon as possible.

Germany may serve as a warning for the United States and the impact from a confusing rollout of booster shots. Ranked 45th for vaccination rates, only 3% of the population has received a COVID booster shot. In the eastern parts of Germany where only 50% of the population is vaccinated, cases are raging again. The German government is planning to deploy 12,000 troops to assist overwhelmed hospitals. Historically, Europe has been a leading indicator of the next surge to hit the Americas.

Earlier this year Israel dealt with a surge of Delta cases when the nation was vaccinated at a similar level to the United States today. The nation implemented a booster program in early July and expanded it twice, making boosters available for everyone 12 and older on September 25. Case rates have returned to a normal level, despite ranking 47th in vaccination rate in the world, and only slightly ahead of the United States.

During a White House briefing on Wednesday, Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention (CDC), said there continued to be a need to prioritize those who are currently eligible for a Covid-19 booster but added, “as you likely know, FDA is currently looking at the data for expanding boosters to all populations.”

Two different studies were released in October 2021, providing insight into how long natural and vaccine immunity last. Neither offer lifetime protection and lifetime protection was never promised. A growing list of studies indicates that natural and vaccine-based immunity wanes after five to seven months.

On October 1, a study on the durability of immunity against reinfection by SARS-CoV-2 was published in The Lancet. Researchers predicted that natural immunity began to fade after 142 to 185 days and natural immunity would disappear after 16 months, The study also stated that this would vary widely depending on age, overall health, genetics, and risk factors, and immunity could be as short as three months or as long as five years.

Three days later, the Lancet published a study on vaccine-based immunity titled Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA. That study indicated that immunity waned from 30% to 50% after five months depending on the mRNA vaccine administered, age, and Covid-19 variants.

Before the first Covid-19 vaccines became publicly available, researchers and scientists were publicly stating that boosters would be likely and that testing programs would evaluate the effectiveness of future boosters. Those predictions came true.

Many people are eligible for booster shots today including 188 million American adults who are overweight with a BMI of 25 or higher.