US FDA approves new Covid shots

Washington, Sep 12

The US Food and Drug Administration (FDA) has approved newly formulated Covid vaccines from Pfizer and Moderna that are more closely targeted to current variants of the disease.

The new Covid vaccines target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. They are monovalent because, unlike the earlier boosters, they do not include protection against the original virus that caused widespread infections three years ago, The New York Times reported.

The US Centers for Disease Control and Prevention (CDC) is expected to follow up on Tuesday with an advisory meeting to discuss who should get the new shots. After a final decision by the CDC’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days, the media report said.

"Covid-19 remains a leading cause of death in the US and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season," Moderna CEO Stephane Bancel said in a statement.

"We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated Covid-19 vaccine at the same time," he added.

Moderna said that its updated Covid-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent Covid-19 in individuals 6 months of age and older.

"This decision comes at a time when Covid-19 cases are once again climbing. Now, most people 6 months or older in the US are eligible to receive this season's Covid-19 vaccine, even if they have never been vaccinated against Covid-19 before," Pfizer CEO Albert Bourla said in a statement.