Update on FDA COVID approvals, actions, and advice

By Jenni Spinner contact

- Last updated on GMT

(Jordan Siemens/iStock via Getty Images Plus)
(Jordan Siemens/iStock via Getty Images Plus)

Related tags: Fda, FDA approval, COVID-19, Coronavirus, Vaccine

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

COVID-19 cases continue to surge in many parts of the US; however, the news that more than half (about 55% of Americans) are fully vaccinated and that vaccines may be approved for children is giving many hope. The US Food and Drug Administration has continued to oversee the life-science industry’s efforts toward new treatments, vaccine boosters, and other work aimed toward abating the pandemic.

Booster authorization

The FDA tweaked the emergency use authorization (EUA) for the Pfizer-BioNTech vaccine for use of a single booster dose, to be administered at least six months after completion of the primary series. Patients receiving the okay include:

  • patients 65 or older
  • adults (18 to 64 years old) at high risk of developing severe COVID-19
  • patients 18 to 64 experiencing frequent exposure to the virus which puts them at high risk of serious COVID-19 complications

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers, and daycare staff, grocery workers and those in homeless shelters or prisons, among others,​” said acting FDA commissioner Janet Woodcock. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day​.”

This EUA applies only to the Pfizer-BioNTech vaccine and not the others currently circulating in the US (Moderna and Janssen).

As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed​,” Woodcock added.

Janssen vaccine EUA

The agency has authorized, under the Janssen vaccine EUA, one additional batch of vaccine drug substance manufactured at the Emergent facility; to date, a total of six batches of Janssen drug substance manufactured at that facility have been authorized.

The FDA reportedly conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and the current COVID-19 public health emergency, the FDA announced it has concluded the batches are suitable for use.

While the FDA commented the agency is not yet prepared to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through previous quality issues there with Janssen and Emergent BioSolutions management.

ANDAs in the COVID era

The FDA revised the guidance Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers​ (first published in April). The guidance provides general recommendations to prospective generic drug applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency.
The FDA reportedly issued the guidance so that the development of generic drugs and submission of applications can continue during the COVID-19 public health emergency, facilitating continued access to safe and effective generic drugs.

False-positive test alert

The FDA sent a letter alerting clinical laboratory staff and health care providers about the potential for false-positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. The letter includes vital information about Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits including details on potential false-positive results, recommendations for clinical laboratory staff and health care providers, actions the FDA is taking, and instructions for reporting problems with the Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP Kits.

EUA for prophylaxis

The FDA revised the EUA for bamlanivimab and etesevimab, administered in combination, to include an emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) at high risk for progression to severe COVID-19, including hospitalization or death.

The bamlanivimab-etesevimab combination is not currently authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus. Bamlanivimab and etesevimab administered together should only be used as post-exposure prophylaxis for specific patient populations, according to the FDA.

Further, the FDA advises, prophylaxis with bamlanivimab and etesevimab administered together is not an acceptable substitute for vaccination against COVID-19. FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death.

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