Pfizer (PFE), BioNTech Omicron BA.4, BA.5 Boosters Get CHMP Nod

Pfizer PFE and partner BioNTech BNTX announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended granting conditional marketing authorization (cMA) for their Omicron BA.4/BA.5-adapted bivalent vaccine.

The recommendation is for use in individuals aged 12 years and older. The “updated booster” contains 15-µg of an mRNA encoding the spike protein present in the original vaccine as well as 15-µg of an mRNA encoding the spike protein that is common in the Omicron BA.4 and BA.5 variants.

The European Commission is expected to give its decision in a few days’ time. Pfizer/BioNTech expect the Omicron BA.4/BA.5 boosters to be available before winter sets in.

Pfizer’s stock is down 19.1% this year so far compared with a decrease of 1.7% for the industry.

Image Source: Zacks Investment Research

BioNTech’s shares are down 42.5% this year so far compared with the industry’s decrease of 21.2%.

Image Source: Zacks Investment Research

In the United States, the FDA, on Aug 31, granted emergency use authorization (EUA) to these Omicron BA.4/BA.5-adapted bivalent vaccines for use as a single booster dose. These boosters can be given at least two months following primary or booster vaccination.

Along with Pfizer/BioNTech, the FDA also authorized Moderna’s MRNA Omicron BA.4/BA.5-adapted bivalent vaccine for individuals 18 years of age and older.

Pfizer/BioNTech and Moderna developed the Omicron BA.4/BA.5-adapted bivalent vaccines at the FDA’s recommendation a couple of months back as the subvariants, BA.4 and BA.5, were the most prevalent variants of concern in the United States. The current vaccines weren’t very effective against the BA.4/BA.5 subvariants.

The FDA, back then, had recommended developing a variant-adapted vaccine that also addresses the spike protein of the Omicron BA.4/BA.5 subvariants. Accordingly, vaccine makers like Pfizer, BioNTech, and Moderna began working on modified boosters of their COVID vaccines to provide better protection from the virus, which has been mutating rapidly. Pfizer/BioNTech’s and Moderna’s Omicron BA.4/BA.5-adapted bivalent vaccines were developed in less than three months from the FDA’s recommendation.

The EMA, the World Health Organization and the International Coalition of Medicines Regulatory Authorities also gave similar recommendations to make bivalent vaccine candidates.

Pfizer/BioNTech’s filings seeking authorization of the Omicron BA.4/BA.5 boosters were based on clinical studies on their bivalent Omicron BA.1-adapted vaccines as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines.

However, unlike all previous approved COVID-19 vaccines, these booster shots’ FDA authorizations are not supported by data from any human clinical studies demonstrating the effectiveness of the vaccine. This has been questioned by some health experts. Though clinical studies on the Omicron BA.4/BA.5-adapted bivalent vaccines have already started, the results will not be available before some months.

Earlier this month, the CHMP had granted a positive opinion to Pfizer and BioNTech’s 30-µg booster dose of Omicron BA.1 bivalent COVID-19 vaccine. CHMP recommended conditional marketing authorization of the booster dose for individuals 12 years and older.

Pfizer/BioNTech’s Omicron BA.1-adapted bivalent COVID-19 vaccine combines 15-µg of mRNA encoding the spike protein in the original vaccine with 15-µg of mRNA encoding the spike protein of the Omicron BA.1 variant.

Zacks Rank and Stocks to Consider

Both Pfizer and BioNTech currently have a Zacks Rank #3 (Hold).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked stock in the same sector is Agenus AGEN, which has a Zacks Rank #1 at present.

Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 21.1% in the year-to-date period.

Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The company delivered a four-quarter average negative surprise of 12.02%.

5 Stocks Set to Double

Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.

Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.