Covid Vaccine Race : Pharma Giant Pfizer and BioNTech Became The First Drugmakers To Release Successful Trial Data
“Today is a great day for science and humanity. 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," Dr. Albert Bourla, Pfizer Chairman and CEO said.
Pharma giant Pfizer and BioNTech today announced their Covid-19 vaccine candidate, BNT162b2, has prevented more than 90% of infections in a study of tens of thousands of volunteers in Phase 3 trials, the most encouraging scientific advance so far in the battle against the coronavirus.
The two companies became the first drugmakers to release successful trial data.
"The mRNA-based vaccine candidate demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study," the company said in a statement.
The preliminary results pave the way for the companies to seek an emergency-use authorization from regulators if further research shows the shot is also safe.
Commenting on the success of the vaccine in the interim phase, Dr. Albert Bourla, Pfizer Chairman and CEO said, “Today is a great day for science and humanity. 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."
"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks, he said."
The findings are based on an interim analysis conducted after 94 participants contracted Covid-19.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule, the study said.
As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
“This is about the best the news could possibly be for the world and for the United States and for public health," said William Gruber, Pfizer senior vice president for vaccine clinical research and development, according to Bloomberg. It was better than even the best result he had hoped for, he said.
With effectiveness for the first vaccines previously expected to be in the range of 60% to 70%, “more than 90% is extraordinary," BioNTech Chief Executive Officer Ugur Sahin said.
Based on current projections, the company said that it expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
The companies have signed advance purchase agreements for 100 million doses with the US and double that with the European Union, with options for more. Supply will fall far short at the beginning.
The partners said they’ll be able to produce enough to inoculate 25 million people this year, less than a third of the population of Germany, where BioNTech is based.
They expect to ramp up production significantly next year, with capacity for as many as 1.3 billion doses. Most of that would be exhausted if the US and the EU exercise their options.
The vaccine requires extreme freezing for long-term storage, which could complicate distribution, although it can stay at refrigerator temperatures for at least five days.
Pfizer shares extended gains in premarket trading, rising about 7%, with BioNTech American depositary receipts up about 11%.
Meanwhile, 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 UK and Brazil expected by year-end.
liveMint with Agency Inputs