Development of a potential vaccination for coronavirus has taken a huge leap forward after Germany-based BioNTech and its American partner Pfizer on Monday published the results of their first large-scale trials, which are still ongoing.
Biontech announced that it wants to ask the US FDA (Food and Drug Administration) for authorization to manufacture the vaccine together with Pfizer.
Italian Health Minister Roberto Speranza welcomed the announcement, but stressed that the Italian public must continue to follow rules set to prevent contagion.
“Today's news about the Covid vaccine is encouraging,” Speranza tweeted. “But a great deal of prudence is still needed.”
“Scientific research is the true key to overcoming the emergency. In the meantime we must never forget that the behaviour of each one of us is indispensable in bringing down the (contagion) curve.”
On Monday, BioNTech and the American pharmaceutical group Pfizer revealed the first data results from their Phase 3 clinical study for the vaccine candidate BNT162b2.
Phase 3 of the trial involved 43,538 participants. These participants received two doses of either the immunisation or a placebo, with 90 percent protected from the virus within 28 days of having their injections.
So that means, according to the results, the risk of contracting Covid-19 was more than 90 percent lower for study participants who received the vaccine than those who didn't.
The firms say there have been no serious side-effects.
“Today is a great day for science and humanity,” said Dr Albert Bourla, the Pfizer chairman. “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.”
“This is the first evidence that Covid-19 can be prevented by a vaccine in humans,” BioNTech CEO Ugur Sahin told Reuters.
BioNTech and Pfizer started their final Phase 3 clinical trial at the end of July.
Meanwhile, Italian researchers are set to begin the third round of clinical trials of a vaccine in December.
Volunteers in Italy could receive the first doses in December, as scientists begin the next phase of trials of a potential vaccine developed by Oxford University and the AstraZeneca pharmaceutical group, and partly manufactured and bottled by two Italian companies near Rome.
The Oxford-AstraZeneca vaccine, one of several in development around the world, is among the most advanced, with a large-scale trial already underway on as many as 10,000 people in the UK.
Phase 3 trials are the final tests before regulators decide whether to approve a drug. The European Medicines Agency, which reviews drugs for use within the European Union, hopes to fast-track approval for Covid-19 vaccines, and the head of Italy's Higher Health Council, Franco Locatelli, has said the first doses could be available in spring 2021.
The new trial is separate from an early-stage trial underway in Rome, where researchers at the Spallanzani National Institute for Infectious Diseases are testing a different vaccine developed by Italian biotech company ReiThera on a much smaller sample of volunteers.