FDA Approves New COVID-19 Vaccines Amid Virus' Summer Surge

The Food and Drug Administration (FDA) on Thursday approved two new COVID-19 vaccines from Pfizer and Moderna. That’s because of a prolonged summer surge in COVID-19 cases. They're likely to spike further this fall. The shots are likely to be available to most Americans within days. 

The FDA approved the new shots nearly three weeks sooner than it did for last year’s vaccines. Those were cleared by the FDA on September 11, 2023. 

There's "waning immunity" among people from prior contact and prior vaccines against the virus, said Peter Marks in a prepared statement. The FDA director said the FDA strongly urges those who can receive the new vaccine to do so. They protect people better against current strains, he said.  

The Centers for Disease Control and Prevention (CDC) advised in June that all people in the US from six months and older get new vaccines for COVID-19 and the flu this year. The new vaccines are approved for those 12 years and older. They can also be given to infants and younger children on an “emergency use” basis.

The FDA action comes amid a large spike in the virus to either “high” or “very high” levels in nearly all states. That's based on wastewater treatment data captured by the CDC. Surveying wastewater has proven to be a good method of gauging the virus’ spread. This is because fewer people are seeking to be tested for COVID-19.    

The new shots are aimed at a strain of the virus called KP.2. It was a main strain in the spring. It now accounts for only 3% of COVID-19 cases. Yet, Pfizer and Moderna say the newest vaccines will also help protect people against other circulating strains.

Reflect: When new health advice or updates come out, how do you decide if it’s something you want to follow or not? What influences your choices?