The first results showing whether a vaccine can prevent people from contracting the virus could come in mid-September from AstraZeneca Plc, according to Airfinity Ltd., an analytics company that tracks drug trials. The drug maker has promised up to 30 million doses for the UK by the end of the month.
Two other contenders, Moderna Inc. of the US and the US-German partnership of Pfizer Inc. and BioNTech SE, may also have initial data ahead of a key Food and Drug Administration meeting on scheduled virus vaccines. by Oct. 22, Airfinity said. A fourth, Sinovac Biotech Ltd. of China, could have preliminary results soon after the meeting.
These first results will be far from the big picture. They are what are known as interim readings – snapshots taken before a study is completed, with only a fraction of the data. The World Health Organization on Monday warned against approving a vaccine before all its risks and benefits are clear. But with the virus resurgence in Europe and its spread in India and America, the initial numbers will be an important early indicator.
The first results should be enough to “give us a very good idea of where we are going,” said Airfinity CEO Rasmus Bech Hansen. “They are moving faster than one could have anticipated.”
Airfinity projections are based on publicly available data on trial enrollment and design, along with infection rates at the sites where patients are enrolled.
Each of these experimental vaccines has already shown promise in smaller trials designed to pinpoint any serious safety concerns and show whether the candidates can stimulate any immune system responses. The first safety data is key; Unlike drugs, vaccines are generally given to relatively healthy people and should not create serious risks.
However, the actual testing ground is a study large enough to show with a high degree of certainty whether a candidate vaccine can work in the real world. This requires tens of thousands of participants, compared to the few hundred people who took the vaccines in early-stage trials.
Drug makers would generally wait for final results before applying for regulatory approval, and the trio of leaders are on track to get that complete data by the end of the year, Airfinity says. In the US, that might not be fast enough. The overwhelmingly positive interim results could lead to studies being stopped early and vaccines being quickly released to the public, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the Los Angeles Times earlier this week.
Political pressure will be high to approve a vaccine if even the initial snapshot of the data from these trials is promising. President Donald Trump has said that a vaccine is possible for the Nov. 3 election and accused the FDA of trying to delay the approval process. Commissioner Stephen Hahn said last week that he is willing to approve a vaccine under an emergency use authorization, which is based on more limited data. Meanwhile, Russia and China have approved experimental vaccines for limited use before testing was completed.
Pfizer has said it is on track to have enough data for an authorization starting in October. Based on how quickly and where it is recruiting people for its 30,000-person trial, it will likely be the first US drug maker with interim data, by October 15, but it won’t have full results until October 17. November, Airfinity projects. . A Pfizer spokeswoman declined to comment on how many virus cases she will need to see to get results in the trial.
Companies testing vaccines in the US, where the virus has spread faster than in Europe in recent months, may have an advantage in terms of potential volunteers and infections. AstraZeneca said it expects results later this year, depending on the infection rate in the communities where it is conducting the trials. J&J said it still plans to begin its late-stage trial this month, with the first batches of vaccine available for possible emergency use in early 2021, pending study results. Sinovac declined to comment. Moderna declined to comment on the deadline for its data readings.
Pharmaceuticals have already reached agreements to supply hundreds of millions of doses to governments around the world.
The WHO has said that any vaccine must be shown to be effective in at least half of the people who receive it to get approval. It will be important to follow the trial participants long enough to see if serious side effects arise, WHO chief scientist Soumya Swaminathan said Monday. Premature approval would make it difficult to continue studying the vaccine in randomized trials, he said. The agency has 176 Covid-19 vaccines in development, of which 33 have entered human trials.
“What’s going to be really important, I think, is making science-based decisions,” Swaminathan said, warning that an “inadequately studied” vaccine could present safety concerns or “low efficacy, so it doesn’t do the job of putting end this pandemic. “
.
