COVID Mitigation Continues with Booster Guidance and Antivirals

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Recommendations for Industry

COVID Mitigation Continues with Booster Guidance and Antivirals

CDC Updates COVID Booster Guidance. The CDC has released an update on individual eligibility for the COVID-19 “booster shot.” The official guidance from both CDC and FDA states that individuals should stay with the vaccine they initially received for booster doses. The update specifically states that the Pfizer “booster” is available for those who received the complete series of Pfizer vaccines at least 6 months ago who are:

  • 65 years and older
  • 18+ who have underlying medical conditions
  • 18+ who work in high-risk settings
  • 18+ who live in high-risk settings

The CDC further defines those in high-risk settings to include:

  • First responders (healthcare workers, firefighters, police, congregate care staff)
  • Education staff (teachers, support staff, daycare workers)
  • Food and agriculture workers
  • Manufacturing workers
  • Corrections workers
  • S. Postal Service workers
  • Public transit workers
  • Grocery store workers

When going to one’s booster appointment, bring the vaccination card you originally received.

Moderna and J&J are also submitting packages for FDA authorization for booster doses, but individuals who received these vaccines and feel the need for a supplemental shot should talk with their health care provider for advice.  Because the Pfizer vaccine is licensed and approved by the FDA, healthcare providers are now allowed to prescribe the vaccine “off-label.”

COVID Fight Also Turning to Antiviral Medications. While vaccines and masking continue to be critical in the fight against COVID, there are now international efforts underway to develop and test antiviral treatments to reduce symptoms, severity, and length of the virus after a person is infected. Similar to Tamiflu, used to reduce the risks and duration of influenza, the COVID antivirals are given early upon exposure and diagnosis to fight the virus; they also have the potential to limit household transmission.

An article from Kaiser Health News discusses three “promising” antivirals being tested in clinical trials, with results expected by winter. They include “top contender” molnupiravir from Merck & Co. and Ridgeback Biotherapeutics, PF-07321332 from Pfizer, and AT-527 from Roche and Atea Pharmaceuticals. Each would be prescribed as pills to be taken for 5 to 10 days after diagnosis.

Remdesivir is the only antiviral approved for COVID treatment thus far, but it is intended for hospitalized patients, not early treatment; and the new medications would be prescribed as pills to be taken for 5 to 10 days, rather than intravenously as remdesivir is.

If the trials have positive results, the medications will be submitted to FDA for emergency use authorization or full approval, at which time the Biden Administration will procure approximately 1.7 million courses of Merck’s molnupiravir, as announced in June. The administration also is investing more than $3 billion to accelerate the discovery, development and manufacturing of antiviral medicines to develop the next generation of COVID-19 treatments.

TAG has long considered the missing element in the COVID fight to be post-diagnosis medications to reduce the impact, and potentially the transmission, of the virus. We look forward to the continuance of the trial, FDA authorization or approval, and wide availability of antivirals – and will continue to keep you informed as information is provided.

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