Four developers were extremely close to receiving approval from the FDA’s Center for Biologics Evaluation and Research at the time, though Pfizer (in conjunction with Biotech) may be the one to pull it off before the end of the year.
This morning, the duo announced a trial that evidences an efficacy rate higher than 90% seven days after the second dose. In other words, those who receive the vaccine achieve protection against the novel coronavirus 28 days later.
The supporting data is set to arrive in the coming weeks, but the 90% effective rate was premised by more than 43,000 volunteers who received either two doses of the vaccine or a placebo.
These trials revealed that less than 10% of infections were in participants who had been given the actual doses while more than 90% of the cases were in people who had been given a placebo.
Pfizer Chairman and CEO, Dr. Albert Bourla said that the new vaccine may be the most significant medical advance of the last 100 years.
“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,” Bourla told CNBC this morning. “We have already signed contracts with multiple governments in the world and they have placed orders.” Commercial markets appear to share in Bourla’s enthusiasm.
Wall Street’s three major indexes reported record highs on Monday and oil prices surged by roughly 8% in response to Pfizer and Biotech’s new vaccine candidate, called BNT162b2.
“Election uncertainty is fading into the rearview mirror. Now we have this boost of investor enthusiasm after the vaccine news,” Michael Antonelli, market strategist at Baird in Milwaukee told Reuters. “All the types of companies that would benefit from us returning to a pre-COVID world are the big winners today.”
This highlights two major points worth clarifying with respect to expectations.
First—Pfizer continues to make concentrated efforts to separate their vaccine work from any political associations. Early in the trial process, the pharmaceutical company rejected distribution assistance from Operation Warp Speed in the interest of non-partisanship.
The federal government will supply $1.95 billion for production and delivery costs for the first 100 million doses that receive emergency approval.
This leads us to our second clarification point.
Pfizer and Biotech have to produce two months’ worth of safety data. Assuming no concerning developments appear, this can be done as early as next week.
Only then, can the U.S. Food and Drug Administration approve emergency authorization. Ideally, Pfizer will prepare up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.
Even if all of the best projections pan out, social distancing and face masks are a must. Depressing clinically recognizable COVID-19 and stopping COVID-19 are two separate objectives that serve the same ones: decreasing hospitalizations and deaths, and stimulating economic recovery.
“It’s important to understand that the end of the battle against Covid-19 is still months away,” President-Elect Joe Biden said of the recent news.
“Even if some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country,” Biden said in a statement. Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year.”
John Bell, an Oxford University professor and vaccines adviser to the U.K., contends that BNT162b2 could spell normalcy around the Spring of 2021.