US and European regulators could approve Pfizer and BioNTech's experimental COVID-19 vaccine as early as mid-December, the German firm's chief executive says, following the release of positive trial results.
Speaking to Reuters TV, Chief Executive Ugur Sahin said if all goes well, the US Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half.
Conditional approval in the European Union could be achieved in the second half of December, he added.
"It will depend on the requests that we will receive and whether all the conditions are met," he said.
Earlier on Wednesday, the partners unveiled trial results showing their shot had a 95 per cent efficacy rate across different age groups and no serious side effects, a major milestone in the race to end the pandemic.
Mr Sahin said that any coronavirus vaccine that clears regulatory hurdles over the next few months will be lapped up by health systems around the world regardless of its relative merits as demand will far outstrip supply.
"I don't really expect a competitive situation over the first nine months because every dose of approved vaccine that anyone can supply is welcome and will likely be used."
Moderna on Monday released preliminary data for its vaccine, showing 94.5 per cent effectiveness.
AstraZeneca, working on a vaccine with Oxford University, is expected to release results from its mass trial before year-end.
"The first five to eight companies (to win approval) will not stand in each other's way... I assume it won't be before mid-2021 that each vaccine will have to distinguish itself with a specific profile," Mr Sahin said.
He added that BioNTech and Pfizer were working on a refined formulation of the vaccine that will not require ultra-cold storage for easier handling in developing countries.
The more robust version would likely be launched during the second half of next year, he said.
For now BioNTech's vaccine must be stored and transported at -70C though it can be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box.
No 'unicorn' magic solution
But the World Health Organization's emergencies director Michael Ryan has warned that vaccines would not arrive in time to defeat the second wave of the Covid-19 pandemic and countries battling a resurgence of the virus would once again have to "climb this mountain" without them.
"I think it's at least four to six months before we have significant levels of vaccination going on anywhere," he said, during a public question and answer session live on social media.
Despite recent promising announcements from final-phase candidate vaccine trials, "We're not there with vaccines yet," Mr Ryan said.
The WHO says a possible vaccine will be too late for the disastrous second wave of COVID-19. Source: Keystone
"Many countries are going through this wave, and they're going to go through this wave, and continue through this wave, without vaccines.
"We need to understand and internalise that, and realise: we have got to climb this mountain this time, without vaccines."
Mr Ryan warned against slackening off individual vigilance against the virus in the mistaken belief that vaccines would now solve the problem instead.
"Some people think a vaccine will be, in a sense, the solution: the unicorn we've all been chasing. It's not," the Irishman said.
"If we add vaccines and forget the other things, Covid does not go to zero."
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