2 More Vaccine Developers Could Seek FDA's Green Light by February - COVID-19 Clinical Trial
Breaking News | COVID-19

2 More Vaccine Developers Could Seek FDA’s Green Light by February

Johnson & Johnson cut its enrollment in its last-stage clinical trial from 60,000 to 40,000 because the virus is so widespread that data on efficacy is coming in faster than the company expected. J&J has so far enrolled more than 42,000 people and will stop recruiting participants later this week, Slaoui said. The vaccine is the only one among the frontrunners that is given as a single dose. “Because it’s a one dose vaccine, they can really scale up very quickly,” Slaoui said. The first efficacy readout of AstraZeneca’s vaccine could come in the second half of January, Slaoui estimated, and the company could potentially file for emergency use later in February.

AstraZeneca has already released data from a mix of late-stage clinical trials, showing that the standard two-dose vaccine was 62 percent effective. A lower dose paired with a standard-strength second-dose was 90 percent effective. That finding was the result of an error impacting a small group of trial participants. On Friday night, the FDA authorized the first vaccine for emergency use from Pfizer. Federal health officials expect the second, for Moderna’s shot, could come later this week.

Pfizer/BioNTech Weren’t Alone: Moderna COVID-19 Vaccine Data Targeted in EMA Cyberattack

Looks like Pfizer and BioNTech’s COVID-19 vaccine was not the sole target of a recent cyberattack at the European Medicines Agency. Moderna said Monday that documents from its pre-submission discussions with EMA about its shot, mRNA-1273, were “unlawfully accessed” by hackers, citing a notification from the agency. The attackers didn’t obtain personal information about trial participants, Moderna said. The company’s EMA submission didn’t include any data identifying individuals in the study.

At this point, no additional details about the cyberattack—such as the scale of the breach or the identity of any suspects—are available, and Moderna said it awaits results from EMA’s ongoing investigation. The revelation came days after the EMA originally disclosed the cyberattack, and Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, was the first identified as a target. EMA decisions on both vaccines are drawing near. Drug reviewers at the EMA’s Committee for Medicinal Products for Human Use are scheduled to assess BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was previously targeted by hackers seeking its COVID-19 research, in a cyberattack allegedly backed by the Chinese government.

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