Pfizer PFE along with partner BioNTech BNTX announced new data from a phase II/III study, which evaluated the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates – one monovalent and the other bivalent.
The bivalent vaccine is a combination of Comirnaty and a vaccine candidate targeting the spike protein of the Omicron BA.1 subvariant.
Data from the phase II/III study showed that participants given the booster dose of both the vaccine candidates generated a substantially higher immune response against the Omicron subvariant BA.1, when compared to Comirnaty, Pfizer/BioNTech’s authorized COVID-19 vaccine.
The phase II/III study evaluated two dose levels, 30 µg and 60 µg, of both the Omicron-adapted COVID-19 vaccines in study participants aged 56 years and older. Those participants who were administered the monovalent candidate as a booster dose elicited a 13.5-fold and 19.6-fold increase in neutralizing geometric mean titers (GMTs) against Omicron BA.1 at 30 µg and 60 µg dose levels, respectively. Conversely, the administration of the bivalent candidate as a booster showed a 9.1-fold and 10.9-fold increase in neutralizing GMTs at the 30 µg and 60 µg dose levels, respectively. These results were observed in participants following one month of dose administration.
The participants who were administered the vaccine candidates demonstrated a safety profile, which was similar to Comirnaty.
Shares of Pfizer have lost 12.6% in the year so far against the industry’s 5.9% rise.
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Shares of BioNTech have plunged 48% in the year so far in comparison with the industry’s 21.7% fall.
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The monovalent and bivalent vaccine candidates have been developed by Pfizer and BioNTech to address the rise of new and evolving Omicron subvariants. Not only do these variants outcompete the BA.1 subvariant but have also shown potential to evade immune protection, which creates a need for adapted vaccine boosters.
Pfizer and BioNTech are also evaluating both the vaccine candidates against the Omicron subvariants, BA.4 and BA.5. Data from the preliminary laboratory studies showed that the monovalent and bivalent candidates efficiently neutralized both the subvariants. However, the neutralizing titers generated on dosing with both the vaccine candidates were three-fold lower than the neutralizing titers against the BA.1 variant.
Pfizer and BioNTech intend to share the above results with the EMA and FDA to market these booster candidates.
The COVID-19 vaccines developed by Pfizer and BioNTech are based on mRNA technology. Another vaccine based on mRNA technology, which poses stiff competition to the Pfizer/BioNTech vaccine, has been developed by Moderna MRNA.
Moderna is also working on developing a new Omicron-based COVID-19 vaccine. Earlier this month, Moderna announced data from an ongoing phase II/III study, which evaluated its bivalent COVID-19 vaccine booster candidate, mRNA-1273.214, targeting the Omicron variant.
The clinical data showed that following one month of administration of the 50 µg dose of mRNA-1273.214, a 5.4-fold increase in neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 was seen in all study participants, regardless of prior infection. In a subset of seronegative participants, the candidate generated a 6.3-fold increase in neutralizing titers against both the Omicron subvariants. Based on these results, Moderna intends to complete the regulatory filing for mRNA-1273.214 in the coming weeks.
Pfizer Inc. Price
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BioNTech SE Sponsored ADR Price
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Zacks Rank & Stock to Consider
Both Pfizer and BioNTech currently carry a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Alkermes ALKS, which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Alkermes’ 2022 bottom line have narrowed from a loss of 10 cents to 3 cents in the past 60 days. Shares of Alkermes have risen 27.7% year to date.
Earnings of Alkermes beat estimates in each of the trailing four quarters, with the average surprise being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.
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