| |
F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine
|
| |
| |
NY Times Dec 10 2020
The efficacy of the vaccine after the first dose is about 52 percent, according to Dr. William C. Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development. After the second dose, that rises to about 95 percent. "Two doses of vaccine provide maximum protection," he said.
Many experts have expressed concern that the coronavirus vaccines might protect some people better than others. But the results in the briefing materials indicate no such problem. The vaccine has a high efficacy rate in both men and women, as well as similar rates in white, Black and Latino people. It also worked well in obese people, who carry a greater risk of getting sick with Covid-19.
Some vaccines for other diseases set off a weak immune response in older adults. But Pfizer and BioNTech found that people over 65 got about as much protection from the coronavirus vaccine as younger people did.
"I found myself trembling reading this," said Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic, referring to the robust response of the vaccines in obese and older people. "This is a grand slam by any measure."
The F.D.A. concluded that there were no "meaningful imbalances" in serious health complications, known as adverse events, between the two groups. The agency noted that four people in the vaccinated group experienced a form of facial paralysis called Bell's palsy, with no cases in the placebo group. The difference between the two groups wasn't meaningful, and the rate in the vaccinated group was not significantly higher than in the general population.
The new Pfizer analysis revealed that many volunteers who received the vaccine felt ill in the hours after the second dose, suggesting that many people might have to request a day off work or be prepared to rest until the symptoms subside. Among those between ages 16 and 55, more than half developed fatigue, and more than half also reported headaches. Just over one-third felt chills, and 37 percent felt muscle pain. About half of those over age 55 felt fatigued, one-third developed a headache and about one-quarter felt chills, while 29 percent experienced muscle pain.
"Taking a day off after the second dose is a good thing to anticipate," Dr. Iwasaki said.
On Monday, Kristen Choi, a psychiatric nurse and health services researcher at the University of California, Los Angeles, published a first-person account of the symptoms she experienced as a participant in the Pfizer-BioNTech trial, which included chills, nausea, headache and fever.
"Clinicians will need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could look a lot like Covid-19," Dr. Choi wrote in the journal JAMA Internal Medicine. She advised doctors to tell patients that these unpleasant symptoms were "a sign that the vaccine is working, despite the unfortunate similarities with the disease's symptoms."
https://www.nytimes.com/2020/12/08/health/covid-vaccine-pfizer.html?action=click&module=Spotlight&pgtype=Homepage
-----------------------------------
F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine
The blessing of these experts means that the agency will likely OK the vaccine's use, paving the way for health care workers to begin getting shots next week.
https://www.nytimes.com/2020/12/10/health/covid-vaccine-pfizer-fda.html
• Dec. 10, 2020
Pfizer's Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.
The F.D.A.'s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the F.D.A. follows the advice of its advisory panels.
With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The F.D.A. is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency's planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.
The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.
The arrival of the first vaccines is the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains, that if successful, will help return a grieving and economically depressed country back to some semblance of normal, maybe by summer.
"With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need," Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said at the meeting.
The vote caps a whirlwind year for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years. It is also a triumph for the F.D.A., which has upheld its reputation as the world's gold standard for drug reviews despite months of political pressure from President Trump, who has sought to tie his political fortunes to the success of a vaccine. The Pfizer vaccine has already been given to people in Bahrain and Britain, where it was authorized on Dec. 2. Canada approved it on Wednesday.
The U.S. authorization of Pfizer's vaccine is expected to be followed soon by one for Moderna's version, which uses similar technology and has also shown promising results in clinical trials. Operation Warp Speed, the Trump administration's multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer's vaccine in July and heavily backed the development and manufacturing of Moderna's vaccine.
More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data.
|
|
| |
| |
|
|
|
