Drugmaker Pfizer has cleared an early hurdle in the race to develop and distribute a vaccine for Covid-19.
The company and its partner BioNTech unveiled interim results early Monday showing that their vaccine was proving more than 90% effective in preventing Covid-19 among patients enrolled in a Phase III clinical study. The results have not been peer-reviewed.
Nonetheless, based on an independent efficacy analysis, they represent a key milestone in the development of a vaccine for a virus that is infecting tens of thousands of people daily and stifling economic activity.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” Dr. Albert Bourla, chairman and CEO of New York-based Pfizer, said in a statement.
Barring any snags, the company said it plans to apply by late November for emergency use authorization from the U.S. Food and Drug Administration.
The interim efficacy results are based on an analysis conducted by the independent Data Monitoring Committee, or DMC. The vaccine candidate, known as BNT162b2, relies on messenger RNA, which is supposed to prompt an immune response to Covid-19.
“The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned,” Bourla said in his statement. “The data will be discussed with regulatory authorities worldwide.”
The analysis of the Pfizer data reviewed 94 confirmed cases of Covid-19 among the study’s 43,538 participants. The vaccine was found to be more than 90% effective in preventing Covid-19 among participants who were not previously infected, according to Pfizer.
The FDA, which has been under pressure to avoid politicizing vaccine approvals, has said it wants roughly two months of safety data from any vaccine before granting emergency use authorization. In a press release, Pfizer and Germany-based BioNTech said they expect to hit that milestone in the third week of November.
“We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed Covid-19 cases have accrued,” BioNTech c0-founder and CEO Ugur Sahin said in a statement.
Additional data will indeed be helpful, said Dr. Erik Hefti, who leads the pharmaceutical sciences program at Harrisburg University of Science and Technology in Pennsylvania.
“While the efficacy is far higher than most expected, we still should approach the news with some caution until further analysis is complete and the results are seen in the total study population and analysis of all safety data is complete,” Hefti wrote in an email.
Hefti also noted the logistical challenges ahead for the Pfizer/BioNTech vaccine, which must be stored at extremely low temperatures and delivered in two injections.
Other promising vaccine candidates have hit snags in phase III studies. An AstraZeneca trial was temporarily halted in September after a participant reportedly suffered an “adverse event” in a participant.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Johnson & Johnson also took a temporary pause this fall after a “serious medical event” in a vaccine-trial participant. “Based on the information gathered to date and the input of independent experts, the company has found no evidence that the vaccine candidate caused the event,” New Brunswick, New Jersey-based Johnson & Johnson said in an Oct. 23 statement disclosing its plans to resume the so-called Ensemble trial.
In a sign of the fervent hopes worldwide for a vaccine, stocks soared on Pfizer’s news. The Dow Jones Industrial Average was up more than 4% by noon Eastern Time. Pfizer’s stock was up nearly 10%, according to Yahoo!Finance.
The news also reverberated in the political sphere.
In an all-caps tweet hailing the announcement, President Donald Trump noted the impact on stocks.
STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!
— Donald J. Trump (@realDonaldTrump) November 9, 2020
https://platform.twitter.com/widgets.js
President-elect Joe Biden struck a more cautious note, citing the timeline for approving and distributing a vaccine in quantities big enough to make a difference.
“Americans will have to rely on masking, distancing, contact tracing, hand washing and other measures to keep themselves safe and well into next year,” Biden said in a statement. “Today’s news is great news, but it doesn’t change that fact.”
While the vaccine news came after the election, its reception still may be colored by politics, said Martin Siegel, an attorney with Lancaster-based law firm Barley Snyder. Based in Baltimore, Seigel worked in the 1980s at the Centers for Disease Control and Prevention in Atlanta and is currently taking part in AstraZeneca’s vaccine study.
Even before Covid-19 became politicized, a vocal group was opposed to vaccines in general, said Siegel, who has a master’s degree in public health. “So the confidence level that the public has in vaccines has gone down over the last half year. There will have to be a significant PR campaign to get people on board.”
Photo: AdrianHillman, Getty Images
