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Moderna's (MRNA) Omicron BA.4/5 Booster Jab Study Meets Goal

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Shares of Moderna (MRNA - Free Report) were up 4.6% after management announced that the phase II/III study evaluating two of its mRNA-based bivalent Omicron-targeting COVID-19 vaccines, mRNA-1273.222 and mRNA-1273.214, achieved their study goals.

The phase II/III study evaluated the bivalent COVID vaccines against a booster dose of the original COVID vaccine, Spikevax (mRNA-1273), in previously vaccinated and boosted participants aged 19-89 years. The study achieved its primary endpoint of generating a superior antibody response in study participants compared with the booster dose of Spikevax. The bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.

The bivalent vaccine contains an mRNA encoding the spike protein in the original/monovalent vaccine and an mRNA encoding the spike protein common in the Omicron variants. While mRNA-1273.222 contains the spike protein in the BA.4/5 Omicron subvariants, mRNA-1273.214 contains the spike protein in the BA.1 Omicron subvariant.

An exploratory data analysis also revealed that both the bivalent vaccines demonstrated robust neutralizing activity against BQ.1.1, an emerging COVID-19 variant. The result from this analysis confirmed that the bivalent vaccines are effective against new and evolving variants. However, the neutralizing activity of these vaccines against the BQ.1.1 variant dropped 5-fold in titers compared with the BA.4/5 variants.

Shares of Moderna have declined 29.5% so far this year compared with the industry’s 19.3% fall.

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Management also stated that the frequency of adverse events observed in patients administered the bivalent vaccines was less than compared with participants who had received the second or third dose of Spikevax.

This August, the FDA granted EUA to Moderna and Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) Omicron BA.4/BA.5-adapted bivalent vaccines for a single booster dose. The Pfizer/BioNTech and Moderna booster vaccines can be given at least two months following primary or booster vaccination.While Moderna’s Omicron booster is authorized for adults aged 18 years and older, Pfizer/BioNTech’s version is approved for people 12 and older.

The EUA was expanded last month to include children as young as five years. Following the EUA expansion, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is authorized for individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.

The above FDA authorizations granted to Pfizer/BioNTech and Moderna are based on clinical studies on their bivalent Omicron BA.1-adapted vaccines and pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. Unlike all previously-approved COVID-19 vaccines, the authorization granted to these booster shots is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness. Encouraging data reported by these companies will help them support their regulatory filings for these vaccines across different countries.

Zacks Rank & Key Pick

Moderna currently carries a Zacks Rank #5 (Strong Sell). A better-ranked stock in the overall healthcare sector is Vertex Pharmaceuticals (VRTX - Free Report) which sports a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex’s stock has risen 39.4% this year so far. While Vertex’s earnings estimates for 2022 have risen from $14.21 to $14.61 per share in the past 30 days, estimates for 2023 have increased from $15.10 to $15.60 per share during the same period.

Vertex beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 3.16%. In the last reported quarter, Vertex reported an earnings surprise of 8.67%.

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