Moment of truth for COVID-19 vaccines may be known this month

Published September 3, 2020, 7:03 PM

by Bloomberg

The moment of truth for the coronavirus disease (COVID-19) front-runners is coming as soon as this month.

(Joe Raedle / Getty Images / AFP / FILE PHOTO / MANILA BULLETIN)

The first results showing whether a vaccine can stop people from getting the virus could come by mid-September from AstraZeneca Plc, according to Airfinity Ltd., an analytics company that tracks drug trials said.

The drugmaker has pledged as many as 30 million doses to the UK by the end of the month.

Two other contenders – the US’ Moderna, Inc. and the US-German partnership of Pfizer, Inc. and BioNTech SE – may also have initial data before a key Food and Drug Administration meeting on virus vaccines scheduled for Oct. 22, Airfinity said. A fourth, China’s Sinovac Biotech Ltd., could have preliminary results shortly after the meeting.

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

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

WHO cautions front-runners

These early results will be far from the full picture. They’re what’s known as interim readouts – snapshots taken before a study is complete, with only a fraction of the data. The World Health Organization on Monday cautioned against approving a vaccine before its full risks and benefits are clear. But with the virus resurgent in Europe and continuing to spread in India and the Americas, 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’re heading,” Airfinity Chief Executive Officer Rasmus Bech Hansen said.

“They are moving faster than one could have anticipated.”

Airfinity’s projections are based on publicly available data on trial enrollment and design, together with infection rates in places where patients are enrolled.

Each of these experimental vaccines has already shown promise in smaller trials designed to flag any serious safety concerns and show whether candidates can spur some response from the immune system.

Early safety data is key; unlike drugs, vaccines are typically given to relatively healthy people and shouldn’t create severe risks.

The real proving ground, though, is a study big enough to show with a high degree of certainty whether a vaccine candidate 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.

Drugmakers would usually wait for final results before requesting regulatory approval, and the trio of front-runners are on track to get that full data by the end of the year, Airfinity says. In the US, that might not be fast enough. Overwhelmingly positive interim results could lead to studies being stopped early and the vaccines being rushed to the public, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the Los Angeles Times earlier this week.

Political picture seen

Political pressure will be high to approve a vaccine if even the initial snapshot of data from these trials is promising. President Donald Trump has said a vaccine is possible by the Nov. 3 election and accused the FDA of trying to slow the approval process. Commissioner Stephen Hahn said last week he’s open to clearing a vaccine under an emergency use authorization, which is based on more limited data. Russia and China, meanwhile, have each cleared experimental vaccines for limited use before testing was complete.

Pfizer has said it’s on track to have enough data for an authorization as early as October. Based on how quickly and where it’s currently recruiting people for its 30,000-person trial, it will probably be the first US drugmaker with interim data – by Oct. 15 – but won’t have full results until Nov. 17, Airfinity projects. A Pfizer spokeswoman declined to comment on how many virus cases it will need to see in order to get results in the trial.

Companies testing vaccines in the US, where the virus has spread more quickly than in Europe for the past several months, may have an advantage in potential volunteers and infections. AstraZeneca said it expects results later this year, depending on the rate of infection in the communities where it’s running trials. J&J said it still plans to start its late-stage trial this month, with first batches of vaccine available for potential emergency use in early 2021, pending the study results. Sinovac declined to comment. Moderna declined to comment on the time-frame for its data readouts.

The drugmakers have already made deals to supply hundreds of millions of doses to governments around the world.

The WHO has said any vaccine should be shown to be effective in at least half the people who get it to gain clearance. It will be important to follow participants in the trials long enough to see whether serious side effects emerge, WHO Chief Scientist Soumya Swaminathan said on Monday. A premature approval would make it hard to continue studying the vaccine in randomized trials, she said. The agency counts 176 COVID19 vaccines in development, of which 33 have entered human trials.

“What’s going to be really important, I think, is to make decisions based on science,” Swaminathan said, warning that an “inadequately studied” vaccine could present either safety problems or “low efficacy, thereby not doing the job of bringing an end to this pandemic.”

175 COVID-19 vaccine candidates

Though Sanofi and Glaxo are just now starting their latest trial, the vaccine front-runners may deliver 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 to secure emergency use authorizations in the fall.

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

The vaccine candidate relies on technology Sanofi uses to make influenza shots and Glaxo’s 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 pre-clinical studies.

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

 
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