Pfizer and BioNTech have made history.
The BNT162b2 of the two companies has become the first COVID-19 vaccine to be authorized in the Western world as drug regulators in the UK issued an emergency use license on Wednesday ahead of US and European decisions due soon this month. expected.
For the wider vaccine world, the Medicines & Healthcare Products Regulatory Agency decision means that the world now has the first mRNA injection approved for widespread use, opening a brand new chapter in vaccine development.
The first doses will be delivered to the UK immediately, the companies said. A spokesperson for the UK’s Department of Health and Social Care said the vaccine will be available nationwide from next week. The UK has ordered 40 million doses of the vaccine – enough to vaccinate 20 million people – through an agreement signed in July and expanded in October.
“As we anticipate further authorizations and approvals, we are focused on moving with the same urgency to safely deliver a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic, ”Pfizer CEO Albert Bourla said in a statement, calling the UK nod a“ historic moment ” .
Pfizer has assigned the production of COVID vaccines to three sites in the US and one in Belgium. BioNTech has facilities in Mainz and Idar-Oberstein, Germany, which have produced doses for clinical trials. The German biotech recently bought a Novartis plant in Marburg to accelerate commercial production of the COVID vaccine. In total, the two companies expect to produce up to 50 million doses in 2020 and up to 1.3 billion doses in 2021.
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Given the initially limited supply, vaccination will be given priority to the most deprived, as determined by the Joint Committee on Vaccinations and Immunizations, which will most likely include residents of long-term care facilities and medical staff.
Data from a phase 3 study showed that BNT162b2 was 95% effective in protecting against SARS-CoV-2, the new coronavirus behind the pandemic. In adults aged 65 and older, efficacy was strong at more than 94%, according to the companies. Impressions like that are remarkable for an infectious disease vaccine. Historically, the effectiveness of seasonal flu shots has hovered around 30% to 40% at best.
Therefore, when the data first came out, SVB Leerink analyst Daina Graybosch predicted that success will “open the floodgates” for the use of mRNA in infectious disease vaccines.
“It is clear to us and investors that mRNA has a place in the vaccine landscape; we expect BioNTech and Pfizer to soon follow their COVID-19 success with other influenza and beyond vaccines, ”Graybosch wrote in an investor note last week.
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But getting an emergency permit is only half the work for a COVID vaccine. Now comes the next big hurdle: distribution.
The Pfizer / BioNTech incorporation requires strict cold chain during transport. It should be stored at approximately -70 ° C. Under normal refrigerated conditions, ie approximately 2 ° C to 8 ° C, the vaccine vial can be stored for up to five days.
With Wednesday’s British nod, Pfizer / BioNTech beat fellow mRNA player Moderna by rolling out the world’s first mRNA vaccine. Before the pandemic, mRNA-1647, Moderna’s CMV vaccine candidate, was the most advanced mRNA program. And the Massachusetts biotech’s mRNA-1273 once led the COVID race until the slower build-up of infections in the Phase 3 study put it by a hair’s breadth behind Pfizer / BioNTech.
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In the phase 3 study, Moderna’s COVID vaccine was 94.1% effective in protecting people from the disease. That shot can be stored at -20 ° C for up to six months, which is the same as most home and medical freezer temperatures. The vaccine can be stable for 30 days under standard refrigerated conditions.
In the US, an independent panel of experts will meet on Dec. 10, convened by the FDA to discuss whether the COVID recordings should be allowed. Industry viewers generally expect a positive opinion and that the FDA will grant emergency use approval within days given the urgent need to use the vaccine amid an increase in the number of new cases.
In addition to BNT162b2, Russia has previously approved a COVID vaccine with adenovirus vector in a controversial move that lacked support from clinical data. The vaccine, called Sputnik V, was recently found to be 91.4% effective in a second interim analysis of a phase 3 trial.
AstraZeneca and the University of Oxford’s adenovirus-based AZD1222 are also approaching a first temporary green light in the UK. trial to validate the results.