Health
Pfizer COVID-19 vaccine may be 90% effective: what you need to know
- Preliminary results from Pfizer’s late vaccine trial suggest that the vaccine can prevent COVID-19.
- This promising development will come when the United States has killed more than 238,000 people and reached another tough milestone of 10 million coronavirus cases.
- The company plans to ask the FDA for an emergency license this month.
Pharmaceutical company Pfizer on Monday Early analysis Analysis of data from the late coronavirus vaccine trial suggests that the vaccine can prevent COVID-19 in people who have never been previously exposed to the virus.
This promising development will come when the United States reaches its next tough milestone. 10 million coronavirus cases, More than 238,000 people have died.
Worldwide, more than 1.2 million people have died of COVID-19.
The Pfizer vaccine has been tested in more than 43,000 people and no significant safety concerns have been observed. news release..
In Phase 3 trials, people were randomly assigned to receive two doses of vaccination (every 28 days) or active placebo. Participants did not know which group they belonged to.
Seven days after the second dose, the company reported that the vaccine’s effectiveness exceeded 90%.
Dr. Sunil SudPreliminary results are very promising, said an infectious disease specialist and pediatrician at Southside Hospital in Northwell Health.
“This shows that most people who developed the infection were placebo recipients, and most of the actual vaccinated people were uninfected.”
The company said it plans to seek an emergency license from the Food and Drug Administration (FDA) by the third week of November.
By then, researchers will follow participants for an average of two months after the second dose.
The company also said in its announcement that it plans to produce up to 50 million vaccines in 2020 and up to 1.3 billion in 2021.
Dr. Carlos MalvestotInfectious disease experts at The Ohio State University Wexner Medical Center say the interim results of Pfizer’s trial are very promising.
“Clearly, 90% protection is the level of protection we want for all vaccines,” he said.
If the efficacy seen during the interim analysis is maintained throughout the rest of the study, it is
90% efficacy is similar to the protection provided by other viral vaccines such as:
However, some researchers told Healthline that not enough data was released to comment on preliminary results.
Pfizer, which developed the vaccine in collaboration with German biotechnology company BioNTech, published interim results in a news release rather than a peer-reviewed medical journal.
The company plans to conduct a final analysis when the number of confirmed COVID-19 cases reaches 164.
However, many questions about vaccines need to be answered.
David VerhoevenPhD, a researcher at the Nanovaccine Institute and an assistant professor of veterinary microbiology and preventive medicine at Iowa State University, states that the level of protection seen during the interim analysis looks good, but how long it lasts. It is not clear.
“We know from nature [coronavirus] An infectious disease that can weaken the immune system in 4 to 6 months, “he said. “”[If this happens with the vaccine], You will probably need booster shots every year. “
It is also unclear whether the vaccine will prevent serious illnesses that increase the risk of dying from COVID-19.
“If researchers can show that people who are vaccinated but are infected with COVID-19 have a mild illness, that would be a big win,” said Malvestutto.
In an interim analysis, researchers only examined whether the vaccine prevented symptomatic coronavirus infections. This includes mild to moderate cases.
Given the recent surge in coronavirus cases in the United States, Malvestot says researchers are likely to see enough severe cases to know if the vaccine will help people in this group.
He states that even if Pfizer meets the FDA’s minimum recommendations for assessing safety, it also needs longer-term data on vaccine safety.
Researchers plan to follow participants for two years after the second dose. The Centers for Disease Control and Prevention also regularly monitors the safety of FDA-approved vaccines.
Pfizer vaccine Not developed The US government’s coronavirus vaccine initiative as part of Operation Warpspeed.
However, the Trump administration has agreed to purchase at least 100 million doses in July.Under this Placement, Americans will receive the vaccine for free.
Pfizer is the first vaccine to show promising results in Phase 3 trials, 10 other vaccines You have reached this stage. These include a wide range of vaccine technologies.
Pfizer vaccines use messenger RNA or mRNA to elicit an immune response in the vaccinated person. The Moderna vaccine is also based on this technology.
This new vaccine platform
Other technologies Used against coronaviruses are vaccines based on the DNA platform, weakened or inactivated versions of the virus, viral protein subunits, virus-like particles, or delivery of coronavirus proteins using another virus.
Some of these technologies are new, while others have been around for years.
“Because both old and new technologies are used, the chances of some vaccines succeeding are actually very high,” says Sood.
Given the size of the pandemic, multiple vaccines may be needed.
“We need multiple vaccines that are well-protected, safe and tolerated, because this is the only way we can actually control this pandemic in a reasonable amount of time,” says Malvestot. ..
However, finding a safe and effective vaccine is just one of the hurdles to overcome.
Vaccines still need to be manufactured and distributed. Pfizer and Moderna vaccines require ultra-cold storage, which further complicates distribution.
Persuading people to actually get vaccinated is another challenge.
Axios-Ipsos Survey From October, it was found that only two-thirds of Americans said they would be vaccinated against the coronavirus if approved by the FDA.
“You can get the best vaccine, but if people don’t take it, it obviously won’t help,” Malvestt said.
One STAT-Harris VotingHowever, it suggests that if the vaccine is highly effective, people may be more aggressively vaccinated.
However, Sood says more work needs to be done to convince people to be vaccinated, especially among hit groups such as black and Latin communities.
“Many community actions at the local grassroots level will be needed to explain the safety and efficacy of the vaccine and the importance of obtaining this vaccine,” he said.
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