FDA Greenlights New COVID Booster as Cases and Hospitalizations Surge. Image by - CT design team.

FDA Greenlights New COVID Booster as Cases and Hospitalizations Surge

Despite the surge in Hospitalization surge, the FDA Authorizes Updated COVID-19 Boosters Targeting Omicron Variants

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Despite the surge in Hospitalization surge, the FDA Authorizes Updated COVID-19 Boosters Targeting Omicron Variants

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The US is experiencing rising COVID-19 cases and hospitalizations this fall. To provide better protection against currently circulating strains, the Food and Drug Administration (FDA) authorized and approved updated COVID-19 booster shots on September 6, 2022.

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The new boosters from Pfizer-BioNTech and Moderna were formulated to target Omicron subvariants that are driving infections in the US and globally. This includes XBB, an emerging mutation of Omicron estimated to account for over one-third of new American cases.

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“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Marks, director of the FDA's vaccine division. “The public can be assured that these updated vaccines have met the agency's rigorous standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

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Next, a Centers for Disease Control and Prevention (CDC) vaccine advisory panel will meet on September 12 to review clinical trial data and provide recommendations on who should receive the updated boosters. This will inform the final sign-off from the CDC director expected in the coming days.

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Rolling out the new boosters to pharmacies and healthcare providers across America is already underway. Meaningful supplies are expected to be available by late September, providing people timely protection as fall and winter respiratory virus seasons approach.

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FDA Emergency Use Authorization and Approval Status of Updated Boosters:

  • Pfizer updated booster approved for ages 12+
  • Moderna updated booster approved for ages 18+
  • Both authorized for emergency use in kids 6 months to 11 years
  • Eligible regardless of how many prior COVID shots received

The FDA authorized the updated Pfizer and Moderna boosters for emergency use in children 6 months to 11 years old if they have completed a primary vaccination series. This includes babies as young as 6 months old who received three doses of the original Pfizer or Moderna vaccines.

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For vaccinated kids under 12, the agency says they can receive one or two updated booster doses depending on age and health status. Unvaccinated children in this age group are eligible for three total doses - the same as their initial primary series.

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Expanding eligibility for the new boosters aims to provide broader protection for babies, toddlers and young kids as infections rise heading into fall and winter months when COVID spreads more easily.

Clinical Trial Data Supporting Updated Boosters

Data recently published by Moderna demonstrated their updated booster generated a nearly nine-fold increase in Omicron BA.4/BA.5 neutralizing antibodies compared to the original booster. This indicates the shot provides superior protection against newer subvariants driving US cases today.

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Additional lab studies showed Moderna's updated vaccine boosts antibodies against Omicron sublineages like BA.2.12.1, BA.4.6, BA.2.75, BQ.1.1 and XBB that have emerged in recent months.

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Earlier results from Pfizer similarly found their updated bivalent booster targeting BA.4/BA.5 elicited a strong immune response and was safe. Especially reassuring, it generated a substantial jump in antibodies fighting Omicron subvariants BA.4 and BA.5 compared to the original booster.

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Real world evidence from rollouts in other countries has affirmed the safety of updated boosters and capability to curtail infections. One UK study found people recently boosted with a bivalent mRNA vaccine were 63% less likely to contract symptomatic BA.5 infection compared to those who received multiple doses of the original vaccine.

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This accumulating data indicates updating boosters to match currently circulating variants provides superior protection that could reduce severe breakthrough cases, hospitalizations and deaths expected this fall and winter.

Fall COVID Preparations and Vaccine Timing

Health officials urge eligible Americans age 12 and up to receive an updated COVID booster when available to strengthen immunity heading into peak respiratory illness season.

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The FDA authorized the new shots at least two months following previous vaccination or booster. But longer intervals of three to six months may provide even higher immune response and longer lasting protection, according to research.

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Many experts suggest optimal timing is getting an updated COVID booster in October before flu activity intensifies. This spaces booster shots 90-120 days from most Americans' last dose while allowing time for immunity to build before holiday gatherings.

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Officials are underscoring that COVID boosters can be safely co-administered with annual flu shots. This provides convenience and saves time getting both vaccines in a single appointment before peak influenza risk season.

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Widespread uptake of the new boosters will be key to controlling surges of breakthrough infections expected with waning immunity and highly mutated Omicron strains circulating aggressively as weather cools. Along with flu shots, they provide a one-two punch combating the “twindemic” threat this fall and winter.

Who Needs an Updated COVID Booster?

The FDA authorized bivalent boosters for all individuals 12 and older who have completed a primary vaccination series, regardless of how many boosters received previously. This expands eligibility for Americans who want to restore and strengthen their protection.

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CDC recommendations on timing and risk groups for the new boosters will follow soon. But health experts strongly advise the updated shots for:

  • Older adults age 50+ at higher risk of severe illness
  • Those with underlying conditions like diabetes, heart disease and lung disease
  • Immunocompromised individuals
  • Pregnant women
  • Residents of long-term care facilities
  • Frontline healthcare workers at risk of infection

Expert Consensus on Updated Boosters

Top government health leaders expressed confidence in the rigor of the booster review process and data demonstrating their benefits.

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“We want to make it absolutely clear that bivalent COVID-19 vaccines formulated with mRNA-1273 or BNT162b2 have been rigorously evaluated and found to meet FDA’s very high standards,” said FDA Commissioner Dr. Robert Califf.

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CDC Director Dr. Rochelle Walensky added: “Updated COVID-19 boosters present us with an opportunity to get ahead of this virus and provide the best protection for people this fall and winter.”

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Dr. Anthony Fauci, the nation’s top infectious disease expert, said the boosters “very likely will provide broader coverage against a broad array of variants.” He emphasized their critical importance with cases ticking up as Omicron evolves.

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Medical groups representing hospitals, doctors and nurses also released statements supporting the boosters as a safe and effective measure to prevent serious fall and winter surges. Their endorsement aims to bolster public confidence after lackluster uptake of the first boosters.

Looking Ahead to Living with COVID

While the pandemic is waning overall in its third year, COVID-19 will remain a threat into the foreseeable future. Scientists say the virus will keep mutating to evade immunity, requiring vaccination strategies to keep pace.

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Regular fall boosters matching prominent strains in circulation are likely needed, similar to annual flu shots. Efforts are already underway with developers planning bivalent vaccines tailored to target newer Omicron relatives emerging globally.

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But with population immunity through vaccination and prior infection now high, the societal disruption caused by COVID is expected to diminish over time. The updated boosters mark an important step in the transition toward potentially managing COVID as a more routine respiratory virus.

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Their authorization comes amid an evolving landscape as people adapt to living with COVID risks by resuming normal activities. While precautions like masking are still wise in high-risk settings, most venues have lifted restrictions and the national public health emergency will soon end.

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In the meantime, getting up to date with the latest recommended vaccines remains the best way for Americans to stay protected against the worst outcomes of COVID-19 and related viruses this fall and winter.


Summarized from the original article by Mary Kekatos and Youri Benadjaoud for abcnews.com

United StatesFood and Drug AdministrationFDACOVID-19CoronaCorona VaccineCovid-19 VaccineCovid-19 Vaccine BoosterCOVID Hospitalization in the USHealth and SafetyPendamicCovid-19 PendamicCorona Pendamic

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