The Food and Drug Administration requested vaccine makers update their Covid shots to include an omicron-fighting element on Thursday, and BNTX stock surged.
BioNTech is Pfizer's Covid vaccines partner. This week, a panel of experts recommended the FDA authorize updated vaccines capable of handling omicron and its subvariants. Sub-variants known as B.A.4 and B.A.5 are now dominant in the U.S.
The updated vaccines will target B.A.4, B.A.5 and the original strain. The FDA said it has directed the companies to begin testing these new vaccines with the plan to launch in the fall.
"We move into the fall and winter, it is crucial that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of Covid-19," the FDA said in a news release.
On today's stock market, BNTX stock jumped 5% to 149.10. Pfizer stock rose a more moderate 2.9% to 52.43. Moderna stock was flat at 142.85 and Novavax stock lost a fraction, ending the regular session at 51.43.
BNTX Stock: Handling New Variants
Thus far, companies have created vaccines that target an earlier sub-variant of omicron, known as B.A.1.
In briefing documents before the FDA panel's meeting, Pfizer said a boosting dose of its original vaccine substantially boosts virus-blocking antibodies capable of handling B.A.1. But the company admitted effectiveness is lower and wanes faster against omicron and its new cousins.
The company tested two vaccines updated to fight the omicron family. One targets B.A.1 alone and led to a 13.5-19.6-fold increase in antibodies, depending on the dosage. The other is a bivalent shot — meaning it takes on multiple strains — and target both the B.A.1 subvariant as well as the original strain. That led to a 9.1-10.9-fold increase in antibodies.
BNTX stock soared more than 7% on Monday after Pfizer posted the briefing documents.
Similarly, Moderna said a fourth dose of its omicron vaccine increased virus-blocking antibodies vs. the B.A.1 subvariant. The vaccine is a bivalent targeting B.A.1 and the original strain. Across all participants, the vaccine led to a 7.1-fold increase in omicron-neutralizing antibodies vs. a 3.8-fold rise following a fourth dose of the original booster.
Novavax uses a different technology. Its protein-based shot is used internationally, but hasn't been authorized in the U.S. It also tested monovalent and bivalent vaccines — targeting B.A.1 and multiple strains, respectively. Those vaccines elicited antibodies against B.A.1, B.A.2 and B.A.5.
Original Vaccines Still In Use
Now, the FDA is hoping these companies will pivot their research to vaccines that target B.A.4 and B.A.5 subvariants.
"We have advised them they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron B.A.4 and B.A.5 component," the FDA said in a news release, sending BNTX stock higher than its rivals.
Importantly, the FDA said it will retain the original primary series of shots. The omicron shots will exist as boosters only. The agency expects 2022 to be a transition year to the new omicron-fighting shots.
"We have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved Covid-19 vaccines provides a base of protection against serious outcomes of Covid-19 caused by circulating strains of (the virus called) SARS-CoV-2," the FDA said.
The booster news is a boon for BNTX stock. Analysts polled by FactSet expect BioNTech's sales to fall this year after peaking at nearly $22 billion in 2021.
By 2026, they expect sales to trickle down to around $3.1 billion. They predict a similar decline for Moderna through 2025 before picking up against in 2026 with the potential launch of new products.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
