…To produce 1.2b doses for 650m people
By Martins Ifijeh in New Jersey, USA
In what appears to be the only point of agreement between the United States President Donald Trump and the President-elect Joe Biden in recent months, they have both congratulated Pfizer on its scientific trial showing its vaccine prevents 90 per cent of COVID-19 infection.
America’s Pfizer and BioNTech are expected to produce 1.3 billion doses of the vaccines for 650 million people by the end of 2021.
Eight months into the worst pandemic in a century, the development represents the most encouraging scientific advancement so far in the battle against COVID-19. And its preliminary results pave the way for the companies to seek an emergency-use authorisation from regulators if further research shows the shot is also safe.
Reacting to the development, President Trump on his Twitter page said: “Stock market up big. Vaccine coming soon. Report shows 90 per cent effectiveness. Such great news.”
On his part, Biden, who inaugurated a COVID-19 taskforce Monday, said: “I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope.” But he cautioned it is “important to understand that the end of the battle against COVID-19 is still months away”.
The president-elect said the announcement was “part of a previously announced timeline by industry officials” and that it does not alter the fact that “Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year”.
The vaccine findings are based on an interim analysis conducted after 94 participants, split between those who got a placebo and those who were vaccinated, contracted COVID-19.
Pfizer Senior Vice-President William Gruber said: “The trial will continue until 164 cases have occurred. If the data hold up and a key safety readout also looks good, it could mean that the world has a vital new tool to control a pandemic that has killed more than 1.2 million people worldwide. This is about the best news for the world, the United States and for public health. It was better than even the best result we had hoped for.”
The Chief Executive Officer, BioNTech, Ugur Sahin, said: “With effectiveness for the first vaccines previously expected to be in the range of 60 per cent to 7 per cent, more than 90 per cent is extraordinary. It shows that COVID-19 can be controlled. At the end of the day, it’s really a victory of science.
“The data do have limits. For now, few details on the vaccine’s efficacy are available. It is not known how well the shot works in key subgroups, such as the elderly. Those analyses haven’t been conducted. And it isn’t known whether the vaccine prevents severe disease, as none of the participants who got COVID-19 in this round of analysis had severe cases.”
The vaccine is being tested in a two-dose regimen. The trial started in July, and since most participants only received their second dose much more recently, nobody knows how long any protection will last.
However, the strong reading from the first large-scale trial to post efficacy results holds well for other experimental vaccines, in particular one being developed by Moderna Inc. that uses similar technology.
Pfizer expects to get two months of safety follow-up data, a key metric required by US regulators before an emergency authorisation is granted, in the third week in November.
If those findings raise no problems, Pfizer could apply for an authorisation in the US this month. A rolling review began in Europe last month, and Sahin said regulators there are working with BioNTech to “further accelerate the process”.
So far, the trial’s data monitoring committee has identified no serious safety concerns, Pfizer and BioNTech said.
The positive preliminary data mean the US pharma giant and its German partner are on track to be first with a vaccine, after signing advance deals with governments worldwide for hundreds of thousands of doses.
Meanwhile, the companies have said they will produce 1.3 billion doses — enough to vaccinate 650 million people — by the end of 2021. Only 50 million doses are expected to be available in 2020.
Pfizer has found itself drawn into a contentious political debate about how quickly regulators in the US should allow a vaccine to be given to Americans.
President Trump pushed to have a shot approved before Election Day, but regulators put in place rigorous standards that largely pushed that goal out of reach.
On October 16, Pfizer Chief Executive Officer Albert Bourla said the companies could seek an emergency use authorisation from US regulators by late November if the trial results were to show the shot is safe and effective.
Writing in an open letter, Bourla quelled fears that Pfizer might be racing the clock to bring out a vaccine before the presidential election.
Pfizer and BioNTech have a $2 billion deal to supply 100 million doses to the US, with an option for 500 million more.
Among the frontrunners, theirs is the only vaccine project that did not take funding from the White House-led Operation Warp Speed programme to bolster research, development or manufacturing. BioNTech received up to €375 million ($445 million) in development funding from the German government, however.
Moderna is considered the next closest vaccine frontrunner. It has said it could get safety and efficacy data from its late-stage trial this month.
Johnson & Johnson, which has a one-shot vaccine using a different technology, could get efficacy data from a final stage trial by the end of this year.
AstraZeneca Plc is also working on a vaccine using different technology, with results from studies in the U.K. and Brazil expected by year-end.