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- Preliminary results from Pfizer’s late-stage vaccine trial suggest that the vaccine may prevent COVID-19.
- This promising development comes as the United States reached another grim milestone of 10 million coronavirus cases, with more than 238,000 deaths.
- The company plans to apply for emergency use authorization from the FDA this month.
Pharmaceutical Pfizer said Monday that an initial analysis of data from its late-stage coronavirus vaccine trial suggests the vaccine may prevent COVID-19 in people who have not been exposed to the virus before.
This promising development comes as the United States reached another grim milestone of 10 million coronavirus cases, with more than 238,000 deaths.
Worldwide, more than 1.2 million people have died from COVID-19.
The Pfizer vaccine has been tested in more than 43,000 people and no serious safety concerns have been observed, the company said in a press release.
In the phase 3 trial, people were randomly assigned to receive either two doses of the vaccine, 28 days apart, or an inactive placebo. The participants did not know which group they were in.
Seven days after the second dose, the vaccine was more than 90 percent effective, the company reported.
Dr. Sunil Sood, president of pediatrics and infectious disease specialist at Northwell Health’s Southside Hospital, says the preliminary results are very promising.
“This shows that the majority of the people who developed the infection were placebo recipients,” he said, “and the majority of those who received the actual vaccine did not become infected.”
The company said it plans to apply for emergency use authorization from the Food and Drug Administration (FDA) by the third week of November.
By then, the researchers will have followed the participants for an average of 2 months after their second dose, such as
The company also said in its statement that it expects to produce up to 50 million doses of the vaccine in 2020 and up to 1.3 billion doses in 2021.
Dr. Carlos Malvestutto, an infectious disease expert at Ohio State University Wexner Medical Center, says the interim results of the Pfizer trial are very encouraging.
“Obviously, the 90 percent protection is the level of protection that we would love to have for all vaccines,” he said.
If the efficacy observed during the interim analysis is maintained for the remainder of the trial, it will exceed the
The ninety percent efficacy is also similar to the protection provided by other viral vaccines, such as
However, some researchers told Healthline that not enough data has been released for them to comment on the preliminary results.
Pfizer, which developed the vaccine in collaboration with German biotech company BioNTech, published the interim results in a press release, not in a peer-reviewed medical journal.
The company plans to do a final analysis when it reaches 164 confirmed COVID-19 cases.
However, many questions about the vaccine remain to be answered.
David Verhoeven, PhD, a researcher at the Nanovaccine Institute and assistant professor of veterinary microbiology and preventive medicine at Iowa State University, says that the level of protection observed during the interim analysis appears good, but it is unclear how long it will last.
“We know of natural [coronavirus] infection that immunity can decline in 4 to 6 months, “he said. “[If this happens with the vaccine], you will probably need annual booster shots. “
It is also unclear whether the vaccine protects against severe disease, which increases the risk of dying from COVID-19.
“If researchers can show that people who are vaccinated and still contract COVID-19 have milder disease, that would be a big winner,” Malvestutto said.
For the interim analysis, the researchers only looked at whether the vaccine prevented symptomatic coronavirus infection, which includes mild and moderate cases.
Given the recent increase in coronavirus cases in the United States, Malvestutto says that researchers will likely see enough severe cases to know if the vaccine helps this group of people.
He says we will also need longer-term data on the safety of the vaccine, although Pfizer will meet the minimum FDA recommendations for evaluating safety.
The researchers plan to follow the participants for 2 years after their second dose. The Centers for Disease Control and Prevention also routinely monitors the safety of FDA-approved vaccines.
Pfizer’s vaccine was not developed as part of Operation Warp Speed, the US government’s coronavirus vaccination effort.
However, the Trump administration agreed in July to buy at least 100 million doses. Under this agreement, Americans would receive the vaccine for free.
While Pfizer’s is the first vaccine to show promising results in a phase 3 trial, 10 other vaccines have reached this stage. These include a wide range of vaccine technologies.
Pfizer’s vaccine uses messenger RNA, or mRNA, to elicit an immune response in people who receive the vaccine. Moderna’s vaccine is also based on this technology.
This new vaccine platform is being
Other technologies that are used against the coronavirus include vaccines based on a DNA platform, weakened or inactivated versions of the virus, viral protein subunits, virus-like particles, or the delivery of a coronavirus protein using another virus.
Some of these technologies are new, while others have been around for years.
“With the use of old and new technologies, our probability of getting several successful vaccines is really very high,” Sood said.
Given the size of the pandemic, multiple vaccines may be needed.
“We will need more of a vaccine that has good protection and is safe and well tolerated,” Malvestutto said, “because that is the only way we can really control this pandemic in a reasonable amount of time.”
However, finding a safe and effective vaccine is just one hurdle that must be overcome.
It would still be necessary to manufacture and distribute vaccines. Pfizer and Moderna vaccines require ultra-cold storage, adding another layer of complexity to distribution.
Convincing people to get vaccinated is another challenge.
An Axios-Ipsos survey from October found that only two-thirds of Americans said they would receive a coronavirus vaccine if it had been approved by the FDA.
“You can have the most amazing vaccine,” Malvestutto said, “but if people don’t take it, obviously that won’t help.”
However, a STAT-Harris survey suggests that people may be more willing to get vaccinated if the vaccine is more effective.
But Sood says more work is needed to convince people to get vaccinated, especially among the hardest hit groups, such as the black and Latino communities.
“It will take a lot of community action at the local level to explain the safety and efficacy of the vaccine, as well as the importance of receiving this vaccine,” he said.
