When you hear Sahin talk about the global race against the virus, these attributes sound distinct. He said he believes BioNexus and Pfizer’s vaccine will not be the only vaccine for Covid 19, and noted that a number of phase 3 vaccine trials are underway.
He reiterated that BioNTech and Pfizer plan to seek approval from the U.S. Food and Drug Administration for the vaccine’s emergency use, with the application possibly as early as next week. He also said that their goal in working with Pfizer is to ramp up production of their vaccine candidate, and that they could produce 1.3 billion doses if it gets approval. The US Food and Drug Administration is expected to authorize her and Bio-NTech’s vaccine for young people, making many vaccinated by the start of the next school year.
In late March, Pfizer and its German partner BioNTech published the results of a study of 2,260 US volunteers aged 12 to 15 years, which showed that the probability of the virus spreading in fully vaccinated adolescents was lower than in 18% of adolescents treated with dummy shots. The announcement in Canada came after the company found that its shot – which is already approved for use by teenagers aged 16 and over – also offered protection to younger groups.
The vaccine, called BNT162b2, has shown 95% efficacy and has been approved by the US Food and Drug Administration (FDA), where vaccination begins at age 12 to 15. The FDA analysis released on December 8 concluded that the two-dose vaccine met all prescribed success criteria for preventing COVID 19 and had a favorable safety profile without major concerns. Sharma said there was evidence that the vaccine was safe and effective in all age groups.
BNT162b2 is currently awaiting conditional approval in the US, while Pfizer, one of the world’s largest pharmaceutical companies, has also filed applications in New York with regulators in Japan and Australia.
The vaccine uses messenger RNA technology to prevent infection with coronavirus, marking the first time an FDA-approved vaccine of this type has been approved for use in the United States. When the first vaccine is given, it marks the mandatory phase, followed by the fastest vaccine development since the pandemic, with Russian and Chinese vaccines being approved in phase III trials. Pfizer’s vaccine is coated with BNT162b2, a breakthrough formula developed by UBC researchers, although the vaccines are not manufactured here in Canada.
Canada will receive the first dose of the vaccine, which has successfully survived clinical trials and is approved by Health Canada. Based on current forecasts, it is expected to produce cans in the range of 1,000 to 2,500 cans per year worldwide, with an annual production capacity of 10 million cans.
Montreal virologist Benoit Barbeau said Canadians should focus on getting a sense of what is happening as new vaccines are being introduced and established adapted to the new variant, rather than developing a new vaccine.
The seven vaccines are among more than 150 candidates under development worldwide. BioNTech has produced 8 million doses of its vaccines at a new Marburg plant that it purchased from Novartis last fall. Sahin and his team are also looking at new variants of the virus that are beginning to spread around the world. They have already developed a vaccine that targets the viral version and plan to test it in the next few months.
Pfizer and BioNTech vaccines are bottled in collaboration with the US Centers for Disease Control and Prevention and stored in the new Marburg factory.
Following the success of the COVID 19 mRNA vaccine, Sahin and Tureci see mRNA technology as the dominant technology in the treatment of other diseases and are preparing to resume work on flu and cancer vaccines interrupted by pandemics.
Three pharmaceutical companies that have submitted provisionally effective COVID-19 vaccines have been approved in the UK, meaning roll-out can begin next week. The plant is the centerpiece of vaccine production and controls the production process in Marburg, where 400 employees produce several million vaccine doses per week around the clock and batches for Pfizer and BioNTech can be produced, which the company says will soon only take 60 days.
The process of end-product manufacturing is heavily regulated by the Food and Drug Administration, he said. The multibillion-dollar effort, codenamed Project Lightspeed by two doctors and scientists, led to the first successful vaccine against cow smallpox, which Edward Jenner vaccinated his gardener son against in 1796, said Dr. Michael Schmitt, CEO and co-founder of BioNTech.
The previous modern record for a vaccine against mumps, set in 1960, was four years. BioNTech, which has pioneered new technologies that could be used to treat cancer in vaccines, is not alone. Moderna, a US biotechnology company, is begging to be behind the development of vaccines that are more efficient than their German counterparts, who are developing the product.
