The U.S. Food and Administration (FDA) has given the green light to updated Covid-19 vaccines, the second-to-last step before the new shots can make their way to patients.
The new vaccines are designed to target the coronavirus' XBB.1.5 lineage, a descendant of the omicron variant that closely matches currently circulating forms of the virus.
Moderna Inc. is one of two drugmakers to get FDA authorization for its new Covid vaccines, along with Pfizer Inc. Novavax Inc., the only drugmaker behind non-mRNA Covid-19 vaccines, was not mentioned in the FDA's statement on Monday, Sept. 11.
Per the FDA authorization, anyone older than four years old can get a single dose of an updated mRNA vaccine — either Moderna or Pfizer — if it's been at least two months since they last got any Covid shot. That includes people who have never received any Covid vaccine.
Read more: When can I get a Covid booster? Here's what to know about fall vaccines
Young children six months to four years old who have previously been vaccinated can get one to two doses of an updated mRNA vaccine. Timing and the exact number of doses will depend on the last Covid vaccine they received, per the FDA. Unvaccinated people in that age group will be able to receive three doses of the updated Pfizer vaccine or two doses of the updated Moderna vaccine.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
In statements over the last few weeks, Moderna has said its shots protect well against the variants BA.2.86, EG.5 and FL.1.5.1. Pfizer and Novavax have put out similar statements.
EG.5 has made up the largest proportion of Covid cases over the last two weeks — 21.5%, according to data compiled by the CDC. FL.1.5.1 follows close behind, making up 14.5% of cases. Notably, the CDC's data is more limited than it was earlier in the pandemic, since its ability to collect it from local authorities was hampered when the national public health emergency ended in May.
On Tuesday, Sept. 12, the new vaccines go to the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, which will make formal recommendations as to who should get the shots and when. CDC Director Mandy Cohen is expected to sign off on those recommendations shortly after. Once she gives the go-ahead, pharmacies and doctor's offices can start offering the shots.
"Covid-19 remains a leading cause of death in the U.S. 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 Stéphane Bancel said in a statement.
Moderna expects to sell anywhere between 50 million and 100 million doses of its new Covid vaccines in the U.S., based on guidance executives provided over the summer. This fall marks the first time the shots will be sold commercially. Moderna's vaccines come in at around $130 a dose, but Americans with health insurance should still be able to get them for free, since federal law guarantees a $0 copay for recommended vaccines.
The CDC is funding a "Bridge Access Program" for Covid shots for uninsured and underinsured people, which will likely be rolled out around mid-October.
Moderna expects to make anywhere between $6 billion and $8 billion on the shots this year. Its share price on Monday was $106.18, down around 1% for the day. The company has a market capitalization of $40.4 billion.
