The Food and Drug Administration urged vaccine makers to update their Covid shots to include an Omicron combat element on Thursday, and BNTX stock surged.
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BioNTech (BNTX) is Pfizer‘s (PFE) partner for Covid vaccines. This week, an expert panel recommended that the FDA approve updated vaccines suitable for Omicron and its subvariants. The subvariants known as the BA4 and BA5 are now dominant in the United States
The updated vaccines target BA4, BA5 and the original strain. The FDA said it has directed companies to begin testing these new vaccines, with plans to launch them in the fall.
“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe outcomes of Covid-19,” the FDA said in a press release.
In today’s trading, BNTX shares are up 5% to 149.10. Pfizer shares rose a more modest 2.9% to 52.43. modern (MRNA) stock was at 142.85 and flat Novavax (NVAX) stock lost a fraction to end the regular session at 51.43.
BNTX share: dealing with new variants
So far, companies have developed vaccines targeting an earlier subvariant of Omicron known as BA1.
In briefing documents ahead of the FDA panel meeting, Pfizer said that a booster dose of its original vaccine significantly boosted virus-blocking antibodies capable of dealing with BA1. But the company admitted that the potency is lower and declining faster against Omicron and its new relatives.
The company tested two updated vaccines targeting the Omicron family. One targets BA1 alone and resulted in 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 targets both the BA1 subvariant and the original strain. This resulted in a 9.1 to 10.9 fold increase in antibodies.
BNTX shares rose more than 7% on Monday after Pfizer released the briefing documents.
Similarly, Moderna said a fourth dose of its Omicron vaccine increased virus-blocking antibodies compared to the BA1 subvariant. The vaccine is a bivalent vaccine targeting BA1 and the original strain. In all participants, the vaccine resulted in a 7.1-fold increase in Omicron-neutralizing antibodies versus a 3.8-fold increase after a fourth dose of the original booster.
Novavax uses a different technology. Its protein-based shot is used internationally but has not been approved in the United States. It also tested monovalent and bivalent vaccines – targeting BA1 and multiple strains, respectively. These vaccines elicited antibodies against BA1, BA2 and BA5.
Original vaccines are still used
Now the FDA hopes these companies will direct their research towards vaccines targeting BA4 and BA5 subvariants.
“We have advised them to submit this data to the FDA for evaluation prior to potential approval of a modified vaccine containing an Omicron BA4 and BA5 component,” the FDA said in a press release, sending BNTX stock higher than its own competitors.
Importantly, the FDA said it will retain the original primary shot series. The Omicron shots will only exist as boosters. The agency expects 2022 to be a transition year to the new Omicron combat footage.
“We have not advised manufacturers to change the vaccine for primary vaccination because a first batch of the FDA approved and approved Covid-19 vaccines provides a baseline of protection against serious consequences of Covid-19 caused by circulating strains of (Dem virus called ) SARS-CoV-2,” the FDA said.
The booster news is a boon for BNTX stock. Analysts polled by FactSet expect BioNTech’s revenue to fall this year after peaking in 2021 at nearly $22 billion.
By 2026, they expect sales to drop to around $3.1 billion. They predict a similar decline for Moderna through 2025, before picking up again in 2026 with the potential for new product launches.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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