“I want to salute a good deed done,” said Peter Doshi, faculty member of the Faculty of Pharmacy at the University of Maryland in Baltimore and editor of BMJ, a medical journal. He had previously requested the plans from Moderna and Pfizer. “They opened up, for the first time, the possibility for researchers not involved in the trial to form their own independent judgment on the design of this study.”
So far, none of the nine companies testing vaccines in large clinical trials has published this level of detail.
Moderna, AstraZeneca and Pfizer, which collaborates with German company BioNTech, are among the pioneers in the global race to produce a vaccine to fight the pandemic.
AstraZeneca did not respond to inquiries about the disclosure of its study plan. Novavax, which is expected to start a large advanced clinical trial later this year, also did not comment. Johnson & Johnson, who said they plan to start a large trial this month, said they would have “more information to share” at the start of the trial.
The AstraZeneca trial was temporarily suspended due to serious illness in one participant. It picked up in Britain and Brazil, but not in the United States.
Previous studies of both vaccines in a small number of people found that after the second vaccine they developed so-called neutralizing antibodies, which can inactivate the virus in lab tests. The vaccines also produced a favorable response involving T cells, another part of the immune system.
Dr Tal Zaks, chief medical officer of Moderna, the first coronavirus vaccine maker to release its detailed plan, said pharmaceutical companies were generally reluctant to do so, due to competitive reasons.