The chief executives of nine companies developing vaccines against COVID-19 issued a joint statement on Tuesday pledging to "uphold the integrity of the scientific process" and make "the safety and well-being of vaccinated individuals our top priority." The announcement had been expected after sources recently suggested that some drugmakers would seek to reassure the public amid speculation of political pressure on the FDA to authorise a vaccine as soon as possible.
In the pledge, signed by CEOs from AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Moderna, Novavax, Pfizer and Sanofi, the companies said they will "only submit for approval or emergency-use authorisation after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as [the] FDA." The drugmakers noted that the agency "has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorisation or approval in the US."
Ugur Sahin, chief executive at BioNTech, which is investigating the candidate vaccine BNT162b2 in partnership with Pfizer, said "we want it to be known that also in the current situation we are not willing to compromise safety and efficacy." A Phase III study of BNT162b2 is currently under way, with Pfizer CEO Albert Bourla recently suggesting that results from the trial could be available by the end of October. Meanwhile, President Donald Trump has repeatedly touted the beginning of November as a possible launch date for a COVID-19 vaccine.
The executives said they hope that the "pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved." Sahin remarked "apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here."
According to Sahin, inclusion in the pledge broadly reflects a significant vaccine market share or a leading position in coronavirus vaccine development. However, separately on Tuesday, SVB Leerink analyst Mani Foroohar highlighted growing "competitive pressure" on Moderna from other developers of COVID-19 vaccines. The analyst said that while Moderna's vaccine candidate, dubbed mRNA-1273, is likely to receive emergency approval by the FDA later this year, "speed to market has fallen behind competitors." Foroohar also cited the risk of reduced end-user demand due to increased scepticism for vaccines rushed to market, which will make a "durable market with oligopoly pricing unlikely."
To read more Top Story articles, click here.