By Ernie Mundell and Robin Foster HealthDay Reporters
MONDAY, Nov. 9, 2020
The early look, from an independent data monitoring committee, gives a first glimpse of the real-world performance of one of four coronavirus vaccines in the last stages of testing in the United States, the Washington Post reported. It is the strongest signal yet that a vaccine could help bring the pandemic to an end in record time.
“I would say it’s a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Kathrin Jansen, head of vaccine research and development at Pfizer, told the Post. “Hearing that at the interim analysis we are over 90 percent effective — it was almost stunning to hear.”
In Pfizer’s 44,000-person trial, there have so far been 94 cases of COVID-19 in people who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine. The data is not yet published or peer-reviewed, and the company news release could not be presented to outside experts under the terms of an embargo, the Post reported.
Ironically, the recent surge of COVID-19 cases has meant that the trial is moving along faster than company executives anticipated, the Post reported. With more people being exposed to the virus now, testing the vaccine becomes a speedier affair.
Importantly, the monitoring committee noted no serious safety concerns. Jansen said the side effect profile of the vaccine includes pain at the injection site and fatigue, chills and fever, which happened more frequently in younger volunteers than in adults over 65.
Pfizer and BioNTech said they plan to submit an application for emergency authorization from the U.S. Food and Drug Administration after the third week of November, when they will have two months of safety follow-up data on half of the participants in their trial, along with data on their manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of COVID-19, a benchmark that Jansen said could take a few weeks to reach.
Federal regulators had set a far lower bar for the minimum performance of a vaccine, mandating that it be at least 50 percent effective, the Post reported.
The vaccine requires two doses, given three weeks apart. Pfizer and BioNTech hope to have 50 million doses ready by the end of the year, and 1.3 billion doses available in 2021.
The vaccine uses a technology never before used: Each injection contains lipid nanoparticles — fat bubbles — that surround a strip of genetic material called messenger RNA, the Post reported. The genetic material carries the blueprint for the distinctive spiky protein that protrudes from the virus’ surface. After being injected, the fat capsule delivers its payload to the body’s cells, and the messenger RNA effectively teaches the immune system how to recognize and block the coronavirus.
Coronavirus cases pass 10 million as Biden announces COVID task force
As America saw its tally of COVID-19 cases pass 10 million on Sunday, President-elect Joseph Biden has said he will announce a task force of coronavirus experts on Monday.
For the first time in the pandemic, the United States is averaging more than 100,000 new cases a day, The New York Times reported. One in 441 Americans have tested positive for the virus just in the last week, the newspaper said.
Twenty-nine states set weekly case records, and the virus is surging in more than half the country, the Times reported. Nationwide, hospitalizations have nearly doubled since mid-September, and deaths are climbing again.
The pandemic is cresting just as President Trump, who remains in office until January, is at odds with his own coronavirus advisers and colder weather pushes people indoors.
Biden is expected to name three co-chairs to his 12-member task force: Vivek Murthy, a former surgeon general, who has been a key Biden adviser for months; David Kessler, a former commissioner of the U.S. Food and Drug Administration; and Dr. Marcella Nunez-Smith, a Yale University professor.
Even so, Biden faces a nation divided over mask rules and lockdowns, and things may well get worse before he assumes the presidency in late January.
Trump has largely shuttered the coronavirus task force and insists the nation is “rounding the corner” in the fight against the virus. Yet, six White House aides and a top campaign adviser tested positive for COVID-19 last week, the Times reported.
All of that comes as family gatherings for Thanksgiving, Christmas and other holidays threaten to seed new outbreaks in the coming months.
“I see this as a very precarious moment,” Dr. Ashish Jha, dean of the Brown University School of Public Health in Rhode Island, told the Times.
The Trump administration has “basically thrown in the towel” on trying to control the pandemic, Jha said, while Biden can only exert “moral power and social power” until Jan. 20.
“Without significant action, the idea that we have another 100,000 deaths by Inauguration Day would be a conservative estimate,” Jha added.
COVID-19 continues to spread around the globe
By Monday, the U.S. coronavirus case count passed 10 million while the death toll passed 238,000, according to a Times tally.
According to the same tally, the top five states in coronavirus cases as of Monday were: Texas with over 1 million; California with nearly 979,000; Florida with nearly 844,000; New York with over 533,700; and Illinois with nearly 489,000.
Curbing the spread of the coronavirus in the rest of the world remains challenging.
Many European countries are tightening restrictions, the Associated Press reported. France began a nationwide lockdown last Friday, and Germany and Austria started partial lockdowns as government officials across the continent scramble to slow a sharp rise in infections that threatens to overwhelm their health care systems.
England followed suit last Thursday, while Italy, Greece and Kosovo also announced new measures, the AP reported.
Things are no better in India, where the coronavirus case count has passed 8.5 million, a Johns Hopkins tally showed.
More than 126,600 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India’s younger and leaner population.
Still, the country’s public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.
Meanwhile, Brazil passed 5.6 million cases and had over 162,000 deaths as of Monday, the Hopkins tally showed.
France surpassed Russia with its case count of 1.8 million on Monday, more than 40,000 deaths. Russia’s coronavirus case count has passed 1.7 million. As of Monday, the reported death toll in Russia was over 30,500, the Hopkins tally showed.
Worldwide, the number of reported infections nearly 50.5 million on Monday, with over 1.2 million deaths, according to the Hopkins tally.
The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
SOURCES: The New York Times; Washington Post
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