New manufacturing capacity will help increase 2021 production to 2bn shots
BioNTech and Pfizer plan to supply an additional 700m doses of their Covid-19 vaccine this year thanks to a new factory in Germany and adjusted European guidelines that allow for an extra shot to be extracted from each vial.
The companies had originally pledged to make 1.3bn doses in 2021 but now intend to provide as many as 2bn, BioNTech said in a statement.
The new production total “is based on continuous process improvements and expansion at the current facilities, and contingent upon adding more suppliers as well as contract manufacturers,” it said.
In addition to extra production from a new facility in Marburg, due to begin next month, European supplies have been boosted by a decision last week by the EU regulator to follow the US and UK in allowing a sixth dose to be extracted from each vial.
Previously, the small containers were only licensed to be diluted into five doses in the EU but healthcare workers had noticed there was material left that was going to waste.
BioNTech said it had shipped almost 33m doses of the vaccine so far from six manufacturing sites in the US and Europe. It has been approved by regulators in the UK, US, EU and more than 40 other countries.
Geoffrey Porges, an analyst at SVB Leerink, said the additional supply was “very good news economically, socially, and medically”.
BioNTech’s projections now far outpace those of Moderna, which has said it will produce between 600m and 1bn doses of its vaccine in 2021.
“Working with a big pharma partner with in-market vaccine experience clearly has benefits in terms of speed of development and manufacturing scale up,” Mr Porges said.
“It’s not as though Moderna has any shortage of cash, but they certainly have to think more carefully about making a billion-dollar bet on a Covid vaccine trial or manufacturing plant than Pfizer does.
”BioNTech and Pfizer have already sold more than 1bn of the doses to be produced this year.
The European Commission announced last week it had reached an agreement to increase its BioNTech/Pfizer order from 300m to 600m doses. The UK has ordered 40m, Japan 120m, while the US has the option to buy up to 600m.
The companies are still in discussion with the Covax programme — led by the World Health Organization, Gavi and the Coalition for Epidemic Preparedness Innovations — to supply the vaccine to the developing world, although no agreement has been reached. The BioNTech/Pfizer vaccine needs to be kept at minus 70C during transit, making it more difficult to distribute in countries without cold-chain infrastructure.
The companies have advised that the vaccine requires two doses 21 days apart to deliver the best protection. However, several countries, starting with the UK, have indicated they plan to delay the second dose in order to give more people at least one dose as soon as possible.
Although this regime is not supported by BioNTech or Pfizer, data from phase 3 trials of the vaccine, which involved more than 43,000 people in six countries, demonstrated recipients gained partial protection from the virus as early as 12 days after the first dose.
The German health ministry has asked the country’s vaccination commission “to review and evaluate the available data and studies and to issue a recommendation on this issue”, while President-elect Joe Biden’s team has said they will consider a similar scheme in the US.
– Financial Times.com