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Pharmaceutical Pfizer said Monday that an early look at the data for its coronavirus vaccine shows that it is more than 90% effective, much better than expected if the trend continues.
The so-called interim analysis examined the first 94 confirmed cases of Covid-19 among the more than 43,000 volunteers who received two doses of the vaccine or a placebo. It found that less than 10% of the infections occurred in participants who had received the vaccine. More than 90% of the cases corresponded to people who had received a placebo.
Pfizer said the vaccine, made with German partner BioNTech, had an efficacy rate of greater than 90% seven days after the second dose, meaning protection is achieved 28 days after a person begins vaccination. The vaccine requires two doses. The US Food and Drug Administration has said that it would expect at least 50% efficacy from any coronavirus vaccine.
In an interview with CNN chief medical correspondent Dr. Sanjay Gupta on Monday morning, Pfizer CEO Albert Bourla called the Covid-19 vaccine “the greatest medical advancement” in the last hundred. years of the world.
“Emotions are running high. You can imagine how I felt when I heard the results yesterday at 2 pm. I think probably, based on impact, this will be the biggest medical breakthrough in the last 100 years,” Bourla said.
“It’s extraordinary, but it comes at a time when the world needs it most,” Bourla said, noting that the United States has recently seen more than 100,000 new cases of Covid-19 daily.
In a press release, the pharmaceutical giant said it plans to apply for emergency use authorization from the FDA shortly after the volunteers have been monitored for two months after receiving their second dose of vaccine, as requested by the FDA.
Pfizer said it anticipated reaching that marker by the third week of November.
In a text message to CNN, Dr. Anthony Fauci called Pfizer’s results “extraordinarily good news!”
Fauci, director of the National Institute of Allergies and Infectious Diseases, said he has not seen the vaccine data himself, but spoke with Bourla Sunday night.
More results to come
There is still more to learn about the Pfizer vaccine.
The phase 3 trial of the Pfizer vaccine has enrolled 43,538 participants since July 27. As of Sunday, 38,955 of the volunteers had received a second dose of the vaccine. The company says that 42% of international testing sites and 30% of US testing sites involve volunteers of various racial and ethnic backgrounds.
The ultimate goal of the trial is to reach 164 confirmed cases of coronavirus infection.
The Pfizer vaccine uses a never-before-approved technology called messenger RNA, or mRNA, to produce an immune response in vaccinated people.
The mRNA vaccine approach uses genetic material called mRNA to trick cells into producing protein fragments that look like parts of the virus. The immune system learns to recognize and attack those bits and would theoretically react quickly to any actual infection.
Pfizer said on Monday that it will evaluate whether vaccines protect people against severe Covid-19 disease and whether the vaccine can provide long-term protection against Covid-19 disease, even in patients who have been previously infected.
“We don’t know how long this protection lasts,” Bourla told CNN.
It is not clear whether the Covid-19 vaccine will become an annual or seasonal vaccine, but Bourla believes it is likely.
“I think he probably needs regular vaccinations,” Bourla told Gupta. “The reason we selected RNA technology was exactly that. This is a technology that can seamlessly enhance creating antibodies against your vaccine, over and over again.”
So far, the vaccine has shown no safety concerns, Bourla said.
“What we know now, is with a very, very high level of confidence, these are very effective vaccines. What we know so far means we don’t have any safety issues, but we have to wait until the results are there,” Bourla said. .
More than 1 billion doses are expected in 2021
Bourla told CNN that Pfizer expects to have 50 million doses of vaccines worldwide this year and 1.3 billion next.
“Who will get this vaccine? We have two separate manufacturing lines. One is in the United States,” Bourla said. “The ones we prefer to use mainly for Americans.”
Bourla added that a second line will be used in Europe to produce vaccines for the rest of the world. “We have already signed contracts with various governments around the world and they have placed orders,” Bourla said.
The vaccine will be free to all American citizens, Bourla said.
Pfizer’s vaccine was not developed as part of Operation Warp Speed, the US government’s coronavirus vaccination effort.
The federal government has invested $ 1.95 billion in Pfizer’s vaccine to help it make 1 billion doses or more by next year, but it is not helping to test it, and Pfizer has said it will distribute the vaccine itself.
President-elect Joe Biden said in a statement that Pfizer’s announcement is “excellent news,” but cautioned that the use of masks and social distancing are still necessary.
President Donald Trump, who had previously suggested that a vaccine could arrive before Election Day, said in a tweet that the Pfizer announcement was “GOOD NEWS!” and noticed that the stock market went up.
When asked about the timing of Pfizer’s announcement on Monday, just days after the election, Bourla said “science brought it exactly at this point.”
“We announced it the moment we found out, and I said multiple times that the pick for us is an artificial timeline,” Bourla said. “This is when science brought it to us.”
Source: graphic.com.gh
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