Several drug makers developing vaccines to counter SARS-CoV-2 plan to issue a public pledge not to seek government approval until the shots have proven to be safe and effective, an unusual joint move among rivals that comes as they work to address concerns over a rush to mass vaccination.
A draft of the joint statement, still being finalized by companies including Pfizer Inc., Johnson & Johnson and Moderna Inc., is expected this week.
Senior regulators at the FDA have also been discussing making their own public statement about the need to rely on proven science.
On Monday, AstraZeneca’s CEO released a statement acknowledging recent questions about the speed of vaccine development. And on Friday, Moderna’s chief executive, Stéphane Bancel, told CNBC that the company was slowing enrollment in its trials to include more people from groups at high risk for Covid-19
Pfizer Chief Executive Albert Bourla said the company expects to have enough data in October to file for an emergency-use authorization if the study results are positive. For Pfizer and Moderna’s vaccines, subjects must return several weeks later to get a second dose, leaving just a few weeks of evaluation for even the first subjects enrolled for a coming regulatory filing.
Read the full story at The New York Times and The Wall Street Journal.
