Moment of Truth for COVID-19 Vaccines May Be Known This Month

The moment of truth for the coronavirus disease (COVID-19) favorites will come as soon as this month.

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 German-US partnership of Pfizer, Inc. and BioNTech SE, may also have initial data ahead of a key Food and Drug Administration meeting on Virus shots scheduled for Oct. 22, Airfinity said. . A fourth, Sinovac Biotech Ltd. of China, could have preliminary results soon after the meeting.

Paris-based Sanofi administered the first patients with its experimental COVID-19 vaccine on Thursday, bringing it one step closer to the late-stage clinical trials it intends to start before the end of the year.

The drugmaker launched human studies at 11 US sites.The phase 1/2 trial, which compresses the early and middle stages of clinical trials, will evaluate 440 healthy patients in two age groups: 18 to 49 years. and over 50. Sanofi, which is developing the vaccine in partnership with GlaxoSmithKline Plc., aims to have results by December, at which point it expects to accelerate to late-stage studies.

WHO warns pioneers

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 image seen

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 fast and where it is currently recruiting people for its 30,000-person trial, it will likely be the first US drug manufacturer with interim data, by Oct. 15, but won’t have full results until Nov. 17, it projects. Airfinity. 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 COVID19 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 a “poorly studied” vaccine could have safety concerns or “low efficacy, so it doesn’t do the job. to end this pandemic. “

175 COVID-19 vaccine candidates

Although Sanofi and Glaxo are just beginning their latest trial, the vaccine pioneers may submit interim data from their late-stage studies as early as this month. There are more than 175 COVID-19 vaccines currently in development, according to the World Health Organization, and 33 in human trials. A handful have ambitions for emergency use authorizations in the fall.

“I’m not concerned that we are a few months behind with some of the other vaccine candidates,” John Shiver, senior vice president of global vaccine research and development, said in an interview. Sanofi’s experience in conducting trials and “experience with very similar viruses” will buy it time relative to its peers, he said, and ultimately multiple injections will be needed.

The candidate vaccine is based on technology that Sanofi uses to make influenza vaccines and Glaxo adjuvants, which enhance the body’s immune response. Sanofi also has a messenger RNA vaccine in development. Shiver said both candidates reported “compelling” data in preclinical studies.

“They showed very, very high levels of neutralizing antibodies in monkeys that are comparable to levels in humans that recovered from Covid-19 infection,” Shiver said of the preclinical studies, to be published in medical journals later this year. . . That data gave Sanofi confidence as it moves to the next stage, he said.