A handful of COVID-19 vaccines are in the last stage of testing, with the final results expected from all the vaccine frontrunners by the end of the year. Assuming the drugs are both safe and effective, vaccination campaigns will then start, targeting healthcare workers and the elderly first. There’s been a lot of talk about Phase 3 results and emergency use authorizations ahead of the US presidential election. The FDA made it clear that the calendar of Phase 3 trials would make it impossible for any of the frontrunners to seek authorization ahead of the election. And some of the companies involved in the late-stage process confirmed they wouldn’t even have interim results ready yet.
Fast forward to Monday, and we have incredible news for one of the novel coronavirus vaccine candidates. The Pfizer/BioNTech drug that’s currently in testing in the US and Germany showed effectiveness that dramatically exceeds expectations. These are interim results though, and things might still change by the time Pfizer seeks regulatory approval.
The US has an efficacy target of 50% for coronavirus vaccines, which would mean the vaccine has to work in at least five out of 10 people. The European Union has not even set an efficacy target. In previous interviews, Dr. Anthony Fauci said that he’s aiming as high as possible in order to ensure better protection, though he cautioned that the first-gen drugs might not be able to reach the effectiveness of other vaccines.
Pfizer said a few days ago that it could not release interim data from the study, as the number of infected volunteers hasn’t reached the minimum threshold. The company was blinded to the study’s progress and was waiting for an independent panel to release results from the Phase 3 test.
The first interim results are now finally in, and they indicate that the Pfizer/BioNTech drug is 90% effective against the novel pathogen. That means it would help nine out of 10 people who get the two-shot vaccine.
“Today is a great day for science and humanity. The first set of results from our phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” Pfizer CEO Albert Bourla said in a statement. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen.”
The figure shows the vaccine prevented 90% of infections in the group of volunteers who received the shots, but the trial will continue and that number could change before the trial is through.
Pfizer recruited some 43,000 people in the Phase 3 trial, and only 94 people have been infected. At 90% efficiency, that means only eight of the 94 infected people received the actual two-dose vaccine, while everyone else who caught COVID-19 was given the placebo. Pfizer will now continue the trial until at least 164 people in the trial are infected.
Pfizer is now collecting safety data, another important element of the Phase 3 trial. That data will be done by the third week of November, at which point the company will request emergency use authorizations in the US and Europe. Pfizer has not published the data in any journal, but it will do so once it has the study’s full results.
Pfizer has also ramped up manufacturing of the vaccine and expects to have 50 million doses by the end of the year, which would be enough to vaccinate 25 million people. Pfizer will make up to 1.3 billion doses next year. It all hinges, however, on whether the vaccine also meets safety expectations.
Several countries have already inked contracts with the company, including the US, the EU, and the UK, which ordered 100 million, 200 million, and 30 million doses, respectively.
The Pfizer/BioNTech does have one huge downside, however. The drug needs to be stored and transported well below freezing temperatures, at -80C (-112F). This might be a tough challenge for various countries when delivering the drug for ample immunization campaigns. BioNTech is already studying whether the vaccine can survive for up to five days at normal fridge temperatures (4C/39F).