Pfizer/BioNTech say COVID-19 jab on track for approval by year-end
Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial.
There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.
The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8 times more neutralising antibodies than in younger patients aged 18-55 recovering from SARS-CoV-2 infection.
In older adults aged 65-85 treated with the vaccine candidate codenamed BNT162b2 there were 1.6 times more neutralising antibodies than in recovering patients.
Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants, the companies said.
The data builds on results announced last month, which also showed the antibody response and suggested that the vaccine produces a T-cell response against the virus.
Those results helped the companies choose BNT162b2 from a group of similar candidates for an ongoing phase 2/3 global study in up to 30,000 participants.
This began in July and has so far enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission.
Assuming the trial is a success, Pfizer and Germany’s BioNTech said they are on track to ask for a regulatory review as early as October, paving the way to supply up to 100 million doses by year end if the vaccine is authorised.
Pfizer and BioNTech are running a parallel trial in Germany and plan to announce further results from that in the “near future”.
There could be up to 1.3 billion doses manufactured by the end of next year, the companies said.
The vaccine is one of 30 potential vaccines identified by the World Health Organization as being in clinical development, with AstraZeneca and Oxford University top of the list.
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