American drug companies Moderna and Pfizer have disclosed its secret blueprints in their respective coronavirus disease (COVID-19) vaccine trials to gain the confidence of the clamoring public and scientific communities.
Both companies have shared previously confidential details about their vaccine development program. Data now available includes the criteria for selecting participants, the standards and procedures for monitoring efficacy and response, conditions or problems that would warrant an early stopping of the programs, and verifiable proof that the vaccinated participants will be protected from COVID-19.
Thank you to the 30,000 participants who have enrolled in our COVID-19 vaccine clinical trial. Your participation will make a difference for those who have been and will be impacted by COVID-19. — Pfizer Inc. (@pfizer) September 16, 2020
Following Public and Scientific Demands
The move follows pressure from researchers who claimed that drug researchers and manufacturers have to be open with their procedures and progress to reassure the public generally distrustful of a potential coronavirus vaccine.
Multinational pharma AstraZeneca found itself in hot waters after the clinical late-stage trial of its own coronavirus vaccine was halted over safety concerns. Later reports confirmed that one of the participants, a previously healthy 37-year-old woman who experienced a neurological condition after receiving the second dose of the vaccine, requiring hospitalization last September 5.
CAMBRIDGE, MASSACHUSETTS - MAY 08: A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of Coronavirus (COVID-19) vaccine trials with 600 participants.
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For Moderna, they have estimated that they will know by November whether their vaccine is effective against the coronavirus. The Cambridge, Massachusetts-based biotech company has released its human trial blueprints Thursday, September 17. Meanwhile, Pfizer and AstraZeneca are looking to provide an update on their respective vaccine trials by October.
Pfizer's late-stage clinical trials will involve up to 44,000 participants, while Moderna has 30,000 participants in its study.
Enrollment update for the Phase 3 COVE study of mRNA-1273, our vaccine candidate against COVID-19. #mRNA pic.twitter.com/LwxXqfO5so — Moderna (@moderna_tx) September 17, 2020
Under normal circumstances, research companies usually disclose the details of their entire vaccine development process after completion. This is usually to protect their advantage from competitors, as well as the relevant intellectual properties. The Moderna and Pfizer disclosure, despite both of their trials still ongoing, is aimed at dressing growing concerns.
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Transparency or Political Pressure?
The timeline detailed by Moderna in its 135-page program protocol mostly corroborates with other conservative estimates on developing a COVID-19 vaccine, including those made by the Director of the Centers for Disease Control and Prevention, Dr. Robert R. Redfield. It declared in front of the Senate Appropriations subcommittee on Wednesday, September 16, that a vaccine might become available to the public by the second or third quarter next year. However, US President Donald Trump contradicted the CDC Director's estimate later in the same day, committing that a vaccine will be available much sooner and will immediately be distributed to the public.
In fact, one of the investigators on Moderna's clinical trials, Dr. Carlos del Rio, has expressed worries in an interview regarding the supposed growing political pressure that interferes in the regulatory approval process for prospective COVID-19 vaccines.
In making his case, Del Rio noted the Food and Drug Administration (FDA) granting emergency approval of the use of convalescent plasma as a potential COVID-19 treatment. The Emergency Use Authorization was issued on the eve of the Republican National Convention.
The same concern is voiced by members of the scientific community, expressing worry that the US administration might influence the regulatory process for coronavirus vaccines.
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