The Atlanta Journal-Constitution
Trial vaccine shows 90% effectiveness
Fauci calls results ‘ extraordinary’ as Pfizer, German firm forge ahead.
A coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90% effective at protecting people compared with a placebo saline shot, according to an interim analysis by an independent data monitoring committee that met Sunday.
The early look at the ongoing trial provides a decisive initial glimpse of the real- world performance of one of the four coronavirus vaccines in the last stages of testing in the U. S. It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.
“I would say it’s a historical moment,” Kathrin Jansen, head of vaccine research and development at Pfizer, said in an interview. “Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years. Hearing that at the
interim analysis we are over 90% effective — itwas almost stunning to hear.”
In Pfizer’s 44,000- person trial, there have so far been 94 cases of COVID- 19, the illness caused by the coronavirus, in people who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine, a strong signal of efficacy. The data is not yet published or peer- reviewed.
“The results are really quite good, I mean extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, adding that the results might bode well for a vaccine being developed by biotech firm Moderna and his institute that uses a similar technology, “which gives you hope we might even have two vaccines.”
Fauci said he had spoken with Pfizer chief executive Albert B our la about the results, but had not yet reviewed the individual data.
Emory University infectious disease expert Dr. Carlos del Rio called the results “exciting” in a telephone interview Monday with The Atlanta Journal- Constitution. Del Rio said hewanted to see the data but was encouraged that it was more than 90% effective and that 42% of the study participants are from diverse backgrounds, which experts hope will increase the public’s confidence in taking a vaccine when it is approved.
Emory is working with Moderna on its vaccine.
Del Rio, who believes a vaccine will be ready by the end of the year, compared the rapid speed of its development to President John F. Kennedy’s call for a moon landing by the end of the 1960s, which was successful in 1969.
“This is just unbelievable,” del Rio said.
Dr. Ted Ross, director of the University of Georgia’ s Center for Vaccine sand Immunology and Georgia Research Alliance eminent scholar, called this early look at the data on the coronavirus vaccine a “highly significant finding.”
“This is an encouraging first step and good news. Let’s hope that other vaccine candidates work just aswell to give us lots of different vaccine options,” Ross said in an email.
And Professor Baozhong Wang at Georgia State’s Institute for Biomedical Sciences also described the promising preliminary results as “terrific news.”
“People should know that a promising COVID- 19 vaccine is very close,” Wang said, which could ultimately put theworld on a path of ending the pandemic.
Even so, Ross and Wang stressed that more data is needed and that several questions remain about the vaccine, including how long immunity would last.
Ross said he also would like to see the breakdown of protective immune responses by gender and by race tomake sure each of these populations has similar immune responses and similar levels of protection against infection.
Another question will be whether the vaccine can offer protection to unvaccinated people. It’s one thing for a vaccine to protect the infected person from developing COVID- 19. But there are questions about whether the vaccinated person, even if they don’ t develop C OVID -19, could still be infected with the coronavirus and shed ( and spread) the virus.
Authorities have stressed it’s unlikely any vaccine will arrive much before the end of the year, and limited initial supplies will be rationed.
The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. Withmore people being exposed to the virus amid the surge, testing the vaccine becomes easier — and faster.
The race for a vaccine had become inextricably tied to electionyear politics, and for months, outside experts had worried that Pfizer’ s vaccine might bean “October surprise” pushed premature ly through the regulatory process. In the end, the data arrived nearly a week after the election, and shortly after the race was called for Presidentelect Joe Biden.
President Donald Trump, who had called Bourla to ask about the vaccine and previously accused regulators of a “political hit job” for slowing down a vaccine, celebrated the news .“STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Trump tweeted Monday morning.
The data committee noted no serious safety concerns. Jansen said the side- effect profile of the vaccine was similar to what was reported in an earlier study. That included pain at the injection site and fatigue, chills and fever - which occurred more frequently in younger trial participants than in adults over age 65.
Pfizer and BioNTech said they plan to submit an application for emergency authorization fromthe Food and Drug Administration after the third week of November, when they will have two months of safety follow- up data on half of the participants in their trial, along with data on their manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of covid- 19, which Jansen said could take a few weeks.