FDA Approves Updated Pfizer, Moderna Covid Vaccines Amid Summer Surge
The Food and Drug Administration (FDA) took a significant step on Thursday by approving updated Covid vaccines from Pfizer and Moderna. With the virus experiencing a summer surge, these new shots are set to reach a large number of Americans in the coming days.
Vaccine Target and Effectiveness The newly approved vaccines target a strain known as KP.2, which is a descendant of the highly contagious omicron subvariant JN.1 that started circulating widely in the U.S. earlier this year. Although KP.2 was the dominant Covid strain in May, it now only accounts for roughly 3% of all U.S. cases as of Saturday, according to the latest Centers for Disease Control and Prevention (CDC) data.
However, Pfizer and Moderna have claimed that their KP.2 vaccines can generate stronger immune responses against other currently circulating subvariants of JN.1, such as KP.3 and LB.1, compared to last year’s round of shots that targeted the omicron strain XBB.1.5. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized in a statement the importance of updated vaccination due to waning immunity in the population from previous virus exposure and prior vaccinations. He encouraged those eligible to consider receiving the updated Covid-19 vaccine to enhance protection against the currently circulating variants.
Approval and Distribution In June, the CDC recommended that everyone over 6 months old receive an updated Covid vaccine along with a flu jab this year. The new Pfizer and Moderna shots are specifically approved for people ages 12 and older and are authorized under emergency use for children aged 6 months through 11 years old.
Pfizer will start shipping its new vaccine immediately and anticipates it being available in pharmacies, hospitals, and clinics across the U.S. “beginning in the coming days,” as stated by the company. Moderna also expects its shot to be available within a similar timeframe.
Moderna CEO Stephane Bancel highlighted in a statement the significance of staying updated with the Covid-19 vaccine as one of the best ways for people to protect themselves and prevent severe illness. He also expressed appreciation for the FDA’s timely review and encouraged individuals to consult their healthcare providers about getting the updated Covid-19 vaccine alongside the flu shot this fall.
The FDA’s approval this year came a few weeks earlier than last year’s round of shots, which were cleared on Sept. 11.
Current Covid Situation The earlier arrival of these updated vaccines is somewhat reassuring considering the current state of the virus in the U.S. this summer. A “high” or “very high” level of Covid is being detected in wastewater in nearly every state, as per CDC data. Since other forms of testing have decreased, wastewater monitoring provides valuable insights into the virus’s prevalence.
Other indicators of the virus’s spread are also on the rise, though still far below pandemic peak levels. The Covid test positivity rate rose to 18.3% for the week ended Aug. 10, from 17.9% the week before, according to the CDC. Additionally, the number of Covid hospitalizations has increased, with about four people being hospitalized for Covid for every 100,000 people in a given area, up from about one hospitalization per 100,000 people in May, which was the lowest level since the pandemic began.
It’s possible that the summer Covid wave might decline by the time the shots take effect in patients, as it typically takes about two weeks after vaccination for an immune response to kick in.
Annual Vaccine Updates and Public Uptake Federal health officials have long advised Americans to expect annual updates to Covid shots due to the virus’s continuous evolution, producing new strains that can evade the immunity gained from previous vaccinations or infections, and because that immunity tends to wane over time. This is similar to the annual rollout of new flu vaccines.
However, it’s uncertain how many Americans will actually opt to get another shot in the coming months. Only around 22.5% of U.S. adults received the latest round of shots that came out last fall, based on CDC data through early May. A November survey from the health policy research organization KFF found that many Americans who skipped previous booster shots cited a lack of concern about the virus or being too busy as reasons.
Novavax’s Situation In June, the FDA initially asked vaccine makers to manufacture shots against JN.1 before changing the target to KP.2 “if feasible.” This shift seemingly put Novavax at a disadvantage as it had filed for authorization of a new JN.1 shot that same month, and the FDA has not yet cleared its jab. Novavax stated that it is working “productively” with the FDA as the agency completes its review and expects its shot to receive authorization in time for the peak vaccination season in the U.S. The company also noted that its shot provides protection against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1, and LB.1.
Vaccine Technologies It’s worth noting the different vaccine technologies in play. Novavax manufactures protein-based vaccines, which are based on a decades-old method used in routine vaccinations like those for hepatitis B and shingles. These protein-based vaccines cannot be updated as quickly to target new virus strains. In contrast, Pfizer’s and Moderna’s shots utilize messenger RNA (mRNA) technology, which instructs cells on how to make proteins that trigger an immune response against Covid. The mRNA vaccines are relatively easier to develop and update compared to protein-based shots.
In conclusion, while the FDA’s approval of the updated Pfizer and Moderna vaccines is a positive step in combating the evolving Covid virus, the level of public uptake remains a key factor. The situation also highlights the differences in vaccine technologies and the challenges faced by different manufacturers in keeping up with the virus’s mutations. The coming weeks and months will show how effectively these new vaccines are distributed and whether they can help mitigate the current and future waves of the virus.