Coronavirus Covid 19: Pfizer Says Vaccine Appears 90% Effective

Pfizer said Monday that the first results of its coronavirus vaccine suggest that the injections can be surprisingly 90 percent effective in preventing Covid-19, putting the company on track to apply later this month for the Emergency use approval from the Food and Drug Administration.

“Today is a great day for science and humanity,” said Albert Bourla, Pfizer president and CEO.

“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 approaching overcapacity and economies struggling to reopen.”

The announcement, less than a week after an election considered a referendum on the handling of the crisis by the president of the United States, Donald Trump, was rare and important news lately in the battle against the scourge that has killed more than 1.2 million people worldwide. including nearly a quarter of a million in the United States alone.

“We are in a potential position to be able to offer some hope,” Dr. Bill Gruber, Pfizer senior vice president of clinical development, told the Associated Press. “We are very excited.”

Dr. Anthony Fauci, the US government’s leading infectious disease expert, said the results suggesting a 90 percent effectiveness are “just extraordinary,” adding: “Not many people expected it to be that high.”

“It’s going to have a huge impact on everything we do with regard to Covid,” Fauci said as Pfizer appeared to take the lead in the overall global race of pharmaceutical companies and various countries to develop a well-proven vaccine against the virus. .

Dr. Bruce Aylward, senior adviser to the World Health Organization, said the vaccine could “fundamentally change the direction of this crisis” by March, when the UN agency hopes to begin vaccinating high-risk groups.

Still, Monday’s announcement doesn’t mean for sure a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the US. And five other countries. . Some participants received the vaccine, while others received sham injections.

Pfizer Inc. warned that the protection rate could change by the time the study ends. Even revealing data this early is very unusual.

Dr. Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division, called the partial results “extremely promising,” but flagged many questions yet to be answered, including how long the effects of the vaccine last and whether protects both the elderly and the very young. some.

Also, whenever a vaccine arrives, initial supplies will be scarce and rationed, and healthcare workers and others on the front lines are likely to be prioritized. Pfizer has estimated that 50 million doses of its two-shot vaccine could be available globally by the end of 2020, which could cover 25 million people.

Global markets, already buoyed by the victory of President-elect Joe Biden, exploded on the news from Pfizer. The S&P 500 was up 3.7 percent after the opening bell, and the Dow Jones Industrial Average was up more than 1,300 points. Pfizer jumped more than 9 percent. Stocks of other vaccines also increased.

Trump, who had suggested repeatedly during the presidential campaign that a vaccine might be ready by Election Day, tweeted: “STOCK MARKET IN BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. WHAT GREAT NEWS!”

Confirmed infections in the US were expected to eclipse 10 million on Monday, the highest in the world. Cases in the United States record all-time highs of more than 100,000 new a day.

The timing of Pfizer’s announcement likely fuels unfounded suspicions by Trump supporters that the pharmaceutical industry was withholding the news until after the election. Donald Trump Jr. tweeted: “The timing of this is pretty amazing. Nothing dire about the timing of this at all, right?”

Pfizer CEO Bourla said on CNBC that the election was always an artificial deadline and that the data would be ready when it was. The independent data monitors met on Sunday to discuss the Covid-19 test results so far and notify Pfizer.

“I’m very happy,” said Bourla, “but at the same time, sometimes I have tears in my eyes when I realize that this is the end of nine months, I work day and night with so many people and how many people.” , billions, hopes invested in this. “

He added: “I never thought it would be 90 percent.”

Scientists have warned for months that any Covid-19 vaccine can be as good as flu vaccines, which are about 50% effective and require annual immunizations. Earlier this year, Fauci said he would be happy with a Covid-19 vaccine that was 60 percent effective.

Pfizer chose not to join the Trump administration’s Operation Warp Speed, which helped half a dozen pharmacists speed up their vaccine trials and helped fund the work. Instead, Pfizer financed all of its testing and manufacturing costs itself. The company said it has invested billions of dollars.

The president’s boasting that a vaccine could be ready before Election Day raised fears that the Trump administration could pressure regulators and scientists to cut costs for political gain. After the first presidential debate, Bourla told his employees that he was disappointed that his work was being dragged into political debates and promised that the company “was advancing at the speed of science.”

The injections, performed by Pfizer and its German partner BioNTech, are among 10 potential vaccine candidates in late-stage trials worldwide, four of them so far in large studies in the US. Another American company, Moderna Inc ., also expects to file an application with the FDA this month.

Volunteers in end-stage studies and researchers do not know who received the real vaccine or a dummy injection. But a week after their second dose, the Pfizer study began counting the number of people who developed symptoms of Covid-19 and were confirmed to have the coronavirus.

Because the Pfizer study is not over, Gruber couldn’t say how many in each group had infections. But the math suggests that almost all of the infections counted so far must have occurred in people who received the fake injections.

Pfizer does not plan to stop its study until it records 164 infections among all volunteers, a number that the FDA has agreed to is enough to know how well the vaccine is working. The agency has made clear that any vaccine must be at least 50 percent effective.

So far, no participant has become seriously ill, Gruber said. It was unable to provide a breakdown of how many of the infections had occurred in older people, who are at higher risk of contracting Covid-19.

Participants were tested only if they developed symptoms, leaving unanswered whether vaccinated people could become infected but show no symptoms and spread the virus without knowing it.

Fauci said that the Pfizer vaccine and virtually all the others in the tests target the spike protein that the coronavirus uses to infect cells, so the latest results validate that approach.

Public Citizen, the consumer advocacy group, called the release of the preliminary and incomplete data “bad science” and said any enthusiasm for the results “should be tempered” until they are reviewed by the FDA and its independent experts.

“The crucial information absent from the companies’ announcement is any evidence that the vaccine prevents severe cases of Covid-19 or reduces hospitalizations and deaths due to the disease,” the organization said.

The FDA has told companies that they should monitor half of their participants for side effects for at least two months, the period when problems generally arise. Pfizer expects to reach that milestone later this month.

Because the pandemic still continues, manufacturers hope to obtain permission from governments around the world for emergency use of their vaccines while further testing continues. That would allow them to get their vaccines to market faster, but it also raises safety concerns.

– AP