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Vaccines

Johnson & Johnson Seeks FDA Approval for COVID-19 Booster Shots

Strategic Insights

— 2 min read

Johnson & Johnson has requested the US Food and Drug Administration to permit extra doses of its COVID-19 vaccine as the US government gears up to expand its booster campaign to millions more vaccinated Americans. The pharmaceutical company filed its petition with the FDA to allow booster shots for individuals 18 and older who received the company's one-shot vaccine. Johnson & Johnson's submission included data on various booster intervals, ranging from two to six months, but the company did not formally recommend one specific interval to regulators.

In a related development, AstraZeneca, the Anglo-Swedish company that developed one of the first COVID-19 vaccines, has asked the FDA to authorize its first-of-a-kind antibody treatment to prevent the disease. The treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency authorization for COVID-19 prevention, but its use would likely be limited to people with compromised immune systems who don't get sufficient protection from vaccination.

The Biden administration's efforts to shore up protection against COVID-19 come as the delta variant continues to spread and potential waning vaccine immunity becomes a concern. The FDA's panel of advisers is scheduled to review booster data from Johnson & J and Moderna next week, amidst worries about creating confusion for tens of millions of other Americans who received the Moderna and J&J shots.

Key Takeaways:

  • Johnson & Johnson has asked the FDA to authorize booster shots for individuals 18 and older who received the company's one-shot vaccine.
  • The company submitted data on various booster intervals, ranging from two to six months, but did not formally recommend one interval to regulators.
  • AstraZeneca has requested FDA authorization for its first-of-a-kind antibody treatment, AZD7442, to prevent COVID-19.
  • The treatment would be the first long-acting antibody combination to receive an emergency authorization for COVID-19 prevention, but its use would likely be limited to people with compromised immune systems.
  • The FDA has authorized three other antibody drugs, including two that can be given after a possible COVID-19 exposure to head off symptoms.
  • AstraZeneca's treatment would be given as a preventive measure, not as a treatment for existing infections.

Statistics:

  • Johnson & Johnson has asked the FDA to authorize booster shots for individuals 18 and older who received the company's one-shot vaccine. [1]
  • The company submitted data on various booster intervals, ranging from two to six months. [1]
  • AstraZeneca's antibody treatment, AZD7442, would be the first long-acting antibody combination to receive an emergency authorization for COVID-19 prevention. [1]
  • The FDA has authorized three other antibody drugs, including two that can be given after a possible COVID-19 exposure to head off symptoms. [1]
  • AstraZeneca's treatment would be given as a preventive measure, not as a treatment for existing infections. [1]

Sources:

  • Associated Press (2021) - Johnson & Johnson asks FDA to allow extra COVID-19 vaccine shots as US expands booster campaign
  • Associated Press (2021) - AstraZeneca asks FDA to authorize emergency use of COVID-19 antibody treatment
  • Federal Register (2021) - FDA Announcement: Booster Shots of Pfizer's COVID-19 Vaccine Authorized for Older Americans and Vulnerable Groups

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