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Moderna Vaccine Trial Missing Data To Judge Vaccine Efficacy, Experts Say

Moderna, Inc.’s (NASDAQ: MRNA) claims on achieving a dose-dependent increase in immunogenicity in Phase 1 trials of its COVID-19 vaccine candidate, mRNA-1273, are not ba

Benzinga · 05/20/2020 06:57

Moderna, Inc.’s (NASDAQ: MRNA) claims on achieving a dose-dependent increase in immunogenicity in Phase 1 trials of its COVID-19 vaccine candidate, mRNA-1273, are not backed by sufficient data, according to vaccine experts. 

The Curious Case Of Antibodies

Moderna made claims on Monday that all 45 subjects who received doses of its vaccine developed COVID-19 binding antibodies.

In its statement, the company indicated that eight volunteers developed neutralizing antibodies. Of the two types of antibodies, neutralizing antibodies are of definitive importance. STAT’s experts question whether the remaining 37 volunteers also developed neutralizing antibodies.

Since the tests required for ascertaining the antibody type present in these remaining 37 volunteers will take time, the experts, interviewed by a health-oriented news portal STAT News, conclude that Moderna only has data for eight subjects. 

The Age Factor 

Phase 1 trial data indicates volunteers ranged from 18 to 55 years. The exact ages of the eight subjects that developed neutralizing antibodies remain unknown. If these eight are of a younger age profile, then the effectiveness of the vaccine for seniors is questionable. COVID-19 has the most devastating effect on the elderly, and protecting seniors should be a priority in the development of any vaccine, according to the vaccine researchers.

Durability Of The Vaccine

Neutralizing antibodies were found two weeks after volunteers received their second dose of the vaccine. According to Anna Durbin, a vaccine expert at Johns Hopkins University, “That’s very early. We don’t know if those antibodies are durable.” 

Vaccine Experts Cautiously Optimistic

On Monday, stock market exuberance led to Moderna’s stock market valuation reaching $29 billion, which is remarkable for a company that is yet to produce any product or bring any vaccine to the pharmacy shelves.

The biotech company does not publish its research in scientific journals and thus lacks confidence within the scientific community. On the lack of disclosure, Rose commented, “My guess is that their numbers are marginal or they would say more.”  Durbin concurs, adding, “I do think it’s a bit of a concern that they haven’t published the results of any of their ongoing trials that they mention in their press release. They have not published any of that.”

The vaccine scientists are of the view that it is “encouraging” that an immune response has been observed after the administration of an RNA vaccine, which has not been seen with previous such vaccines for other pathogens. They question whether that’s enough. Durban says she is “cautiously optimistic.”

Moderna Price Action

Moderna shares traded 6.01% lower at $67.36 after-hours on Tuesday. The shares had closed the regular session 10.41% lower at $71.67.