Article previously published on Yahoo Finance on November 20, 2020
The U.S. has moved one step closer to getting its first COVID-19 vaccine, with BioNTech (BNTX) — Pfizer’s (PFE) development partner — filing for emergency use authorization Friday morning. “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Pfizer CEO Albert Bourla. With the coronavirus crisis reaching a crescendo worldwide, steps toward approving and distributing a COVID-19 inoculation have taken on increasing urgency.
BioNTech’s move comes just days after the two companies announced their two-dose vaccine is 95% effective against the coronavirus, and that they planned to file for regulatory approval “within days.” While data supporting the statement has yet to be released, health officials are cautiously optimistic. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said a vaccine’s efficacy is one thing — but the effectiveness in the real world is another. “If you like at highly efficacious vaccines through the years, they’ve crushed formidable outbreaks like smallpox, like polio, like measles,” Fauci said — calling the 95% threshold “extraordinary.”
Yet concerns still exist over the ease of distributing the BioNTech/Pfizer vaccine, as well as other candidates that could also soon be authorized, to reach the far corners of the country. President-elect Joe Biden noted that the decision by Operation Warp Speed — the Trump administration’s initiative to fund and produce domestic vaccine candidates — to partner with Walgreens (WBA) and CVS (CVS) was not ideal to reach rural residents, and some communities of color. “So we have to make sure there is access for them,” Biden said during a press briefing Thursday.
Rural access to a vaccine — and the significantly lower volume demands that could affect prioritization— is a concern expressed by Amerisource Bergen’s Good Neighbor Pharmacy president. Meanwhile, Walgreens has noted on its website that its pharmacies are within several minutes of 80% of the country’s population. But Warp Speed officials said Wednesday there are already plans to help support areas that need an ultra-cold freezer or other support. On Thursday, Gen. Gustave Perna said there are already 100 million vaccine kits ready to ship, along with the vaccines, 24 hours after an emergency use authorization is granted.
Brandon Daniels, president of global markets at consulting firm Exiger, said now that the vaccine’s efficacy is known, the supply chain’s efficacy is being put to the test. “Now, we’re seeing cryogenics companies and packaging companies starting to become more significant names in the supply chain,” Daniels said. It’s possible that the mass coronavirus testing infrastructure, created to help reach hard-to-reach communities, could play a key in vaccine distribution as well, he added. Meanwhile, states are already preparing to receive the first shipment of vaccines in mid-December, with the expectation that frontline health care workers and nursing homes will be at the top of the priority list.