Covid-19: two American vaccine manufacturers unveil the rules for their clinical trials


Moderna documents at the Research Centers of America, Hollywood, Fla., August 13, 2020 (AFP / CHANDAN KHANNA)

The American companies Moderna and Pfizer on Thursday published the clinical trial protocols of their experimental vaccines against Covid-19, the only ones among the nine most advanced manufacturers in the world to respond to calls for more transparency.

The biotechnology company Moderna released Thursday morning its first protocol: a 135-page document that governs phase 3 of its trial, to verify on 30,000 volunteers the effectiveness and safety of its experimental vaccine.

Then its competitor Pfizer, an American pharmaceutical group which is developing a vaccine with the German BioNTech, imitated it.

Moderna and Pfizer are the only ones with active Phase 3 in the US, and the most likely to be cleared first here.

These protocols are usually confidential. “We recognize, however, that the Covid-19 pandemic is a unique circumstance, and that the need for transparency is clear,” a Pfizer spokeswoman told AFP.

The vaccine race has taken a very political turn in the United States in the run-up to the November 3 presidential election, Donald Trump still pledging on Wednesday to have a first vaccine authorized by October, thus raising doubts about possible pressure on the Medicines Agency (FDA), which will have to make the decision.

“I do not trust Donald Trump,” accused his Democratic rival Joe Biden.

Experts and Trump administration officials say the results of ongoing trials cannot be predicted, and that it is unlikely to have results before the end of 2020 anyway. The doses will be wrong. be available only in very limited quantities initially, insist the health authorities.

Moderna itself expects results in November. October is possible, but “unlikely,” the company’s chief executive, Stéphane Bancel, told CNBC Thursday.

But Pfizer, on the other hand, maintains as “probable” to have results before the end of October.

– Wait –

The protocols published Thursday set all the parameters of the trial, including the criteria for when and how to judge whether the results are conclusive. Their publications will allow experts to compare their rules, in particular to confirm cases of Covid-19.

The reality of a vaccine trial is that you have to wait until a certain number of volunteers are naturally contaminated, in order to compare the placebo group to the one that was actually vaccinated (the trials are blind: the participants and their doctors do not know which group they belong to).

The current slowdown in the American epidemic can therefore only delay the results; maybe in December, warned Stéphane Bancel.

To date, Pfizer has recruited 29,000 participants, and Moderna 25,296, of whom 10,025 have received the second dose, separate from the first by 28 days. It will take several more weeks for the 30,000 targeted participants to receive both doses.

Interim analyzes, by committees of independent experts, are planned to verify whether a statistical threshold of effectiveness has been reached, and to monitor the appearance of serious side effects.

The FDA has said it will approve a vaccine showing at least a 50% reduction in the risk of getting sick from Covid-19.

“There is the key information for the stopping rules, the interim analyzes and the hypotheses of efficiency. I welcome their transparency”, reacted to AFP, after the publication of Moderna, Eric Topol, director of Scripps Research Institute and one of the experts leading the charge for more transparency.

– Follow the example –

Moderna also announced that 28% of the participants were from minorities. Having enough black and Hispanic participants, in particular, is crucial in order to ensure effectiveness for these communities disproportionately hit by the pandemic.

Another manufacturer, AstraZeneca, partner of the University of Oxford, started phase 3 this summer in the United States, but global trials were suspended last week due to unexplained illness in one participant. They resumed in the UK, Brazil and South Africa, but not in the US, without explanation.

“Transparency is critical to tackling vaccine hesitation. Other vaccine manufacturers should follow Moderna’s lead,” Angela Rasmussen, a virologist at Columbia University, commented on Twitter.

ico / sdu


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