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.
Keep safe all guys .