Updated Pfizer and Moderna Covid vaccines approved by FDA; shots to be available soon.

Updated Pfizer and Moderna Covid vaccines approved by FDA; shots to be available soon.
Updated Pfizer and Moderna Covid vaccines approved by FDA; shots to be available soon.
  • Updated Covid vaccines from Pfizer and Moderna have been approved by the Food and Drug Administration, allowing the shots to be distributed to Americans in the near future as the virus continues to spread.
  • The jabs aim at a strain known as KP.2, which is a descendant of the highly contagious omicron subvariant JN.1 that became widespread in the U.S. during the current year.
  • This year, the CDC advised that individuals over 6 months old should receive an updated Covid vaccine.

On Thursday, the Food and Drug Administration approved updated Covid vaccines from Pfizer and Moderna, paving the way for the new shots to be distributed to Americans in the near future as the country experiences a summer surge of the virus.

The jabs target a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that was dominant in May but now accounts for only roughly 3% of all U.S. cases as of Saturday, according to the latest Centers for Disease Control and Prevention data.

Pfizer and Moderna have stated that their KP.2 vaccines are more effective in generating stronger immune responses against other subvariants of JN.1, including KP.3 and LB.1, compared to the vaccines developed last year to target the XBB.1.5 strain of omicron.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, advised that due to the declining immunity of the population from previous exposure to the virus and prior vaccination, eligible individuals should strongly consider getting an updated COVID-19 vaccine to better protect against current variants.

The CDC advised that all individuals over 6 months old should receive an updated Covid vaccine and flu shot in June. The new Pfizer and Moderna vaccines are specifically approved for people aged 12 and above and are authorized under emergency use for children aged 6 months to 11 years old.

Pfizer will start shipping its new vaccine immediately and anticipates it being accessible in pharmacies, hospitals, and clinics across the U.S. "in the coming days," the company announced in a statement. Similarly, Moderna expects its vaccine to become available in the coming days, as stated in a company announcement.

"Moderna CEO Stephane Bancel stated that staying current with your COVID-19 vaccine is crucial for protection and prevention of severe illness. He added, "We thank the U.S. FDA for their prompt review and advise individuals to discuss their updated COVID-19 vaccine with their healthcare providers, along with their flu shot this fall.""

The FDA has recently approved the vaccine a few weeks earlier than the previous round, which was cleared on Sept. 11.

The availability of updated vaccines could provide some comfort to Americans as the country experiences a significant increase in virus cases this summer. Nearly every state has detected a "high" or "very high" level of Covid in wastewater, according to CDC data. Wastewater monitoring offers a snapshot of the virus's prevalence in the U.S., as other testing methods have declined.

By the time the shots are administered and the immune response kicks in, the summer Covid wave may decline.

As the virus continues to mutate, federal health officials advise Americans to anticipate regular updates to their Covid-19 vaccinations, similar to how the U.S. releases new flu vaccines annually.

The number of Americans who will receive another vaccine shot in the near future is uncertain.

According to CDC data through early May, only approximately 22.5% of U.S. adults received the latest round of shots that were released last fall.

According to a November survey from KFF, many Americans who received previous rounds of Covid shots stated that they were not concerned about the virus and hence did not get the latest booster. Additionally, some individuals mentioned that they were too occupied to receive their shot, the survey revealed.

In June, the FDA instructed vaccine manufacturers to prioritize creating shots against JN.1, but later suggested targeting KP.2 if it was feasible.

The biotech company's jab, which filed for authorization of a new JN.1 shot that same month, was put at a disadvantage by the shift in the FDA's decision to not clear the biotech company's jab.

Novavax is collaborating "effectively" with the FDA as the agency finalizes its evaluation, and the company anticipates obtaining authorization for its vaccine before the peak vaccination season in the US.

The company's shot protects against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

Protein-based vaccines, which are used in routine vaccinations against hepatitis B and shingles, cannot be quickly updated to target another strain of the virus.

Moderna and Pfizer's vaccines employ messenger RNA technology, which instructs cells to produce proteins that trigger an immune response against Covid. Unlike protein-based vaccines, mRNA vaccines are simpler and more adaptable to changes in the virus.

by Annika Kim Constantino

Business News