Pfizer, BioNTech nab COVID-19 vaccine authorization from U.K. for first-ever marketed mRNA shot

Pfizer and BioNTech have made history.

The two companies’ BNT162b2 has become the first COVID-19 vaccine allowed in the Western world as drug regulators in the U.K. doled out an emergency use authorization on Wednesday, ahead of decisions by the U.S. and Europe, which are expected soon.

For the broader vaccine world, the Medicines and Healthcare products Regulatory Agency’s decision means the world now has the first mRNA shot authorized for widespread use, opening up a brand-new chapter for vaccine development.

The first doses will be delivered to the U.K. immediately, the companies said. A spokesperson at the U.K.’s Department of Health and Social Care said the vaccine will be made available across the country from next week. The U.K. has ordered 40 million doses of the vaccine—enough to vaccinate 20 million people—through a deal signed in July and expanded in October.

“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply 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, Ph.D., said in a statement, calling the U.K. nod a “historic moment.”

Pfizer has assigned COVID-19 vaccine manufacturing to three sites in the U.S. and one in Belgium. BioNTech has facilities in Mainz and Idar-Oberstein in Germany, which have been producing doses for clinical trials. The German biotech recently bought a Novartis plant in Marburg, Germany, to accelerate commercial manufacturing of the COVID-19 vaccine. Overall, the two companies have said they can produce up to 50 million doses in 2020 and up to 1.3 billion doses in 2021.  

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Given the initial limited supply, vaccination will be prioritized toward people most in need as determined by the Joint Committee on Vaccinations and Immunisations, who will most likely include long-term care facility residents and healthcare staff.

Data from a phase 3 study showed BNT162b2 was 95% effective at protecting against SARS-CoV-2, the novel coronavirus behind the pandemic. In adults age 65 and above, the efficacy stood strong at above 94%, according to the companies. That kind of showing is remarkable for an infectious disease vaccine. Historically, effectiveness of seasonal flu shots has been hovering at around 30% to 40% at best.

That’s why, when the data first came out, SVB Leerink analyst Daina Graybosch predicted that the success is going to “open the floodgates” of applying mRNA in vaccines for infectious diseases.

“It is clear to us and investors that mRNA have a place in the vaccine landscape; we expect BioNTech and Pfizer to quickly follow their COVID-19 success with other vaccines for influenza and beyond,” Graybosch wrote in an investors note last week.

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But getting an emergency use authorization is only a job half done for a COVID-19 vaccine. Now comes the next big hurdle—distribution.

The Pfizer/BioNTech shot requires stringent cold chain during transportation. It must be stored at around minus 70 degrees Celsius. At normal refrigerated conditions—around 2 C to 8 C—the vaccine vial can only be kept for up to five days.

To help keep the vaccine cold, the companies have designed special boxes. Once open, a vaccination center may use the boxes as a temporary storage place to maintain the recommended ultracold storage conditions for up to 30 days with re-icing every five days. Still, the companies don’t expect the vials will need to be stored at one place for this long given the urgency of deployment. 

With Wednesday’s U.K. nod, Pfizer/BioNTech beat fellow mRNA player Moderna to it in rolling out the world’s first mRNA vaccine. Before the pandemic, Moderna’s CMV vaccine candidate, mRNA-1647, was the most advanced mRNA program. And the Massachusetts biotech’s mRNA-1273 was once leading the COVID-19 race until slower accumulation of infections in the phase 3 trial put it behind Pfizer/BioNTech by a hairbreadth.

RELATED: Moderna sketches out 94.1% efficacy for COVID-19 vax based on more cases, with EUA plotted for today

In its phase 3 trial, Moderna’s COVID-19 vaccine was 94.1% effective in protecting people from the disease. That shot can be kept at minus 20 C, which is equal to most home and medical freezer temperatures, for up to six months. At standard refrigerated conditions, the vaccine can stay stable for 30 days.

In the U.S., an independent expert panel convened by the FDA will meet Dec. 10 to discuss whether the COVID-19 shots should be allowed. Industry watchers generally expect a positive opinion and that the FDA will grant the emergency use authorization within days given the urgent need to deploy the vaccine amid a surge in new cases.

Besides BNT162b2, Russia has previously approved an adenovirus-vectored COVID-19 vaccine in a controversial move that lacked clinical data support. Dubbed Sputnik V, the vaccine 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 is also nearing an initial temporary green light in the U.K. But a phase 3 trip-up that led to an unexpectedly high—90% efficacy—has raised eyebrows, and the company is planning to run a separate trial to validate the results.