Virus World

The U.S. Food and Drug Administration needs at least two months of safety data before authorizing emergency use of any experimental Covid-19 vaccine. Pfizer’s CEO Albert Bourla said the company would file for emergency approval as soon as safety data is available, assuming those results are positive. The FDA requires at least two months of safety data on half of trial participants to grant emergency approval, he said, as well as information on effectiveness and proof it can be manufactured safely. The safety data is likely to take the longest to collect — Bourla said Pfizer expects to have manufacturing data before that and should know whether or not the vaccine is effective by the end of October. The company will continue to monitor and report safety data for all trial participants for two years, Bourla said. Bourla said the November timeline reflects the company’s “best estimates,” noting that this could change.

Bourla’s statement cements Pfizer’s status as a frontrunner — alongside Germany’s BioNTech, who it is developing the vaccine with — in the global race to develop a safe and effective Covid-19 vaccine. Excluding Russia and China, which have licensed vaccines for domestic use, no manufacturer has been granted regulatory approval for a vaccine anywhere in the world. If Pfizer manages to stick to this timeline, it could be the first. Pfizer and other vaccine-makers have grown increasingly frustrated with the persistent politicization of potential Covid-19 vaccines by high-ranking officials, most notably President Trump, who has claimed one will be ready before the November 3 election. Bourla’s letter does little to hide this annoyance,stating: “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas.”

Late last week, Stat reported that Moderna would delay the phase 3 study of its COVID-19 vaccine, thanks to changes to the trial’s protocols. Such changes are not uncommon, highlighting just how closely watched anti-COVID-19 efforts are, but the delay is part of a trend of tensions in the biotech’s relationship with the U.S. government. Those tensions include resisting government experts’ advice on how to run the study and seeking a lower bar than proposed by the FDA to prove the vaccine works, as well as turning in trial protocols late, three sources familiar with the vaccine project told Reuters. Moderna, which has a pipeline of more than 20 mRNA vaccines and treatments, has not yet brought a medicine to market. It is one of five drug developers selected under the U.S. government’s Operation Warp Speed, an initiative that aims to deliver a COVID-19 vaccine to Americans by the end of this year.

Although Moderna has already secured up to $483 million for its mRNA vaccine from the Biomedical Advanced Research and Development Authority (BARDA), Warp Speed can set it up with additional funding, clinical trial assistance and manufacturing help. The other four finalists—Pfizer, Merck, AstraZeneca and Johnson & Johnson—are all established drugmakers that have experience running large, late-stage trials and with whom the government is not “facing similar problems.” Moderna, like its peers, has been given “significant control” over its phase 3 program, but it has been “less forthcoming” with the government about its plans, Reuters reported. As for the trial launch, Moderna said it “made the call” to delay it, but the sources told Reuters that the biotech did not have enough staff to finish the trial protocols on time. Before it started work on a COVID-19 vaccine, Moderna’s largest clinical trial involved about 250 patients, according to ClinicalTrials.gov. It plans to test its vaccine in 30,000 people. It has also sought a lower threshold for proving if its vaccine worked and resisted the government scientists’ insistence on monitoring trial participants’ oxygen levels, a marker that could indicate dangerous complications, Reuters reported. Although it said monitoring could be a “hassle” that slowed down development, the company eventually aligned with the agency on both points....