What to Know Now That the FDA Has Approved New COVID Shots

What to Know Now That the FDA Has Approved New COVID Shots

The fight against COVID-19 continues to evolve as the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have given their approval for two new Covid shots. Developed by Pfizer-BioNTech and Moderna, these vaccines are now recommended for everyone aged 6 months and up, marking a significant expansion in eligibility compared to previous vaccines.

These newly approved vaccines come at a crucial time as Covid-19 cases have seen fluctuations in different parts of the United States. Although hospitalizations and fatalities have decreased over the past year, the virus has not stood still. It has mutated into more than two dozen variants, causing concerns over immunity waning.

Less than 20 percent of Americans received the previous booster, a bivalent shot introduced last fall. It was designed to safeguard against the original virus and specific Omicron subvariants. However, immunity, especially through antibodies, tends to diminish within a few months.

The newly reformulated Covid shots aim to better combat the latest set of subvariants circulating in the U.S. Unlike their predecessors, the latest mRNA vaccines from Pfizer and Moderna are monovalent, designed to protect against a single variant: XBB.1.5. This variant is a descendant of Omicron and emerged earlier this year.

While XBB.1.5 may no longer be the dominant variant, preliminary research indicates that the new vaccines should still provide protection against the currently dominant variant, EG.5, and other variants that have raised concerns, such as BA.2.86. Data from various academic labs suggests that patients infected with XBB.1.5 who hadn't yet received the vaccine developed sufficient neutralizing antibodies against current virus versions.

Pfizer and Moderna have reported that their new Covid vaccines offer effective protection against both EG.5 and BA.2.86, based on initial research. Regulators are also evaluating a third monovalent shot developed by Novavax against XBB.1.5, which uses a different approach as a protein-based vaccine.

It's important to note that these new vaccines do not include protection against the original virus. Surprisingly, this limitation might actually broaden protection against new variants.

The number of doses needed for the new vaccine depends on your age and previous immunizations:

  • Everyone aged 5 and older is eligible for a single dose of the updated mRNA shot, regardless of vaccination history.

  • Children aged 6 months to 4 years who have previously received Covid vaccines can receive one or two doses.

  • Unvaccinated children in the 6-month to 4-year age group are eligible for three doses.

Major pharmacy chains such as Walgreens and CVS have confirmed they will provide these Covid shots to all eligible individuals based on CDC guidelines. Additionally, local pharmacies, doctor's offices, and public health departments may offer the new vaccine.

In the past, the U.S. government purchased and distributed Covid vaccine doses for free. However, the cost of the reformulated shots will now be negotiated by private insurance companies and government payers like Medicare. Most individuals with private or public health insurance will likely continue to receive the vaccines for free if administered by in-network providers. Uninsured individuals may access the new Covid shots for free through community health centers, as vaccine makers are expected to donate doses for this group. A government program is also expected to facilitate access to the vaccines through 2024.