The FDA Reveals the New Name for the Pfizer COVID Vaccine
The vaccine will be marketed as a vaccine to protect against COVID-19 disease for those 16 years old and up.
Anyone from 12 to 15 years old can get the vaccine under emergency use approval, but it has not been fully approved for those age groups.
FDA Grants Full Approval to Pfizer/Biontech COVID-19 Vaccine
The U.S. Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older,” the FDA said in its announcement on Monday.
Maryland Gov. Hogan Calls for Expedited Approval of COVID-19 Vaccine in Children Under 12
Maryland Governor Larry Hogan called for an expedited approval for the COVID-19 vaccine in children younger than 12 years old on Monday.
In a statement following the approval of the Pfizer COVID-19 vaccine by the U.S. Food and Drug Administration (FDA), Hogan wrote, “We want to thank federal officials for authorizing full approval of the Pfizer vaccine, which is something we have been pushing for over the last several weeks. For people who are still hesitant about getting the vaccine, this is an assurance that it has met the most rigorous standards for safety and effectiveness.”
“We also continue to call on the federal government the expedite approval so that our 5- to 11-year-olds can begin receiving COVID-19 vaccines,” the statement continued. “Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away.”
Pfizer and BioNTech Surge After the FDA Officially Approves Its COVID-19 Vaccine
Shares of Pfizer and BioNTech surged on Monday after the FDA officially approved their COVID-19 vaccine.
Pfizer jumped as much as 5% to near record highs, while BioNTech was up as much as 11% in Monday trades …
Pfizer’s first-mover advantage in the COVID-19 space helped the company gain more than $30 billion in revenue from its vaccine in 2021. That revenue figure could move even higher going forward as the company evaluates a third booster shot, which is expected to be administered next month.
Monoclonal Antibodies Are Free and Effective Against COVID-19, but Few People Are Getting Them
When Mike Burton came down with a breakthrough case of COVID-19 earlier this month, the infection posed a double threat to his family. At 73, the retired surgeon faced elevated risk of serious illness. His wife, Linda, has a suppressed immune system, the result of drugs she takes after two liver transplants that put her in greater danger of life-threatening illness.
The Burtons, both vaccinated, moved to separate parts of their Mount Sterling, Ky., home, masked up and hoped for the best.
Then a friend called and insisted they ask their doctors about monoclonal antibodies — an effective, widely available COVID-19 therapy that few people are receiving.
WHO Chief Calling for Two-Month Halt on Vaccine Boosters
World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus on Monday called for a two-month moratorium on COVID-19 booster shots as many low- and middle-income countries still struggle to provide enough vaccine doses for their citizens.
The Associated Press reported Ghebreyesus made these remarks while speaking to reporters in Budapest. The WHO head argued that “vaccine injustice and vaccine nationalism” fuels the risk of more infectious COVID-19 variants emerging.
He had made a similar call for a moratorium on booster shots in richer nations earlier this month, arguing that it has yet to be proven whether a booster shot is any more effective at preventing COVID-19 transmission than the two shots that are normally administered.
Burial Costs Covered for Canadians Killed by Approved Vaccines
Burial costs will now be covered by Ottawa for individuals killed by federally approved vaccines.
According to Blacklock’s Reporter, the department of health will pick up the tab and says the new program “addresses a longstanding gap in Canada’s national immunization programming by providing a timely, no-fault financial support mechanism for all people in Canada, in rare instances where they are seriously and permanently injured performing a public good, being immunized.”
The Vaccinated Are Worried and Scientists Don’t Have Answers
Anecdotes tell us what the data can’t: Vaccinated people appear to be getting the coronavirus at a surprisingly high rate. But exactly how often isn’t clear, nor is it certain how likely they are to spread the virus to others.
Though it is evident vaccination still provides powerful protection against the virus, there’s growing concern that vaccinated people may be more vulnerable to serious illness than previously thought.
There’s a dearth of scientific studies with concrete answers, leaving public policy makers and corporate executives to formulate plans based on fragmented information. While some are renewing mask mandates or delaying office reopenings, others cite the lack of clarity to justify staying the course. It can all feel like a mess.
Nascar Star Says Asking About Vaccinations Like Asking About Vasectomies
He said he watches where he goes and who he’s with and this week canceled three public appearances. He also went a step further and got vaccinated.
Corey LaJoie became an example of what can happen to unvaccinated NASCAR drivers: He missed Sunday’s race at Michigan because the rules state that competitors who haven’t gotten jabbed but are exposed to someone who tested positive for COVID-19 must quarantine for seven days.
New Evidence Points to Antibodies as a Reliable Indicator of Vaccine Protection
When Dr. Anthony Fauci spoke recently at a White House briefing about the need for COVID-19 booster shots, buried in his slideshow of charts and data points was a little-noticed scientific paper that offers evidence for a reliable way to predict how much protection a COVID-19 vaccine offers.
The study appeared on a preprint server earlier this month without much fanfare, but many interested in the future of COVID-19 vaccines had been eagerly awaiting the results.
The researchers were looking for markers in vaccinated patients’ blood that would indicate protection against COVID-19, what’s known as “correlates of immunity.” What the team of scientists found were neutralizing antibodies — proteins made by the immune system that are known to disarm the coronavirus.
FDA Warns Against Ivermectin as COVID Treatment
The Food and Drug Administration (FDA) reiterated a warning against the use of ivermectin as a COVID-19 treatment amid growing reports of individuals taking the drug often used to treat parasitic worms in animals.
Mississippi state health officials issued a recent alert prompted by increasing calls of people with potential ivermectin exposure taken to prevent or treat COVID-19 infection. While the drug has FDA-approval for certain uses in animals and humans, over 70% of the recent calls involved livestock formulations, officials said.
The FDA previously issued concerns over self-medication with ivermectin intended for animals, noting some people might mistakenly believe the drug can substitute for ivermectin intended for humans.
China Hits Zero COVID Cases With a Month of Draconian Curbs
It’s been just over a month, and China has once again squelched COVID-19, bringing its local cases down to zero.
It was more difficult this time, even though the leaders of the world’s most populous nation used the same playbook they followed to quell more than 30 previous flare-ups. The arrival of the more infectious delta variant has raised the stakes, as the pathogen refines its ability to escape curbs and flout vaccination. It’s unclear how long the victory will last.
The China model shows what it takes to get COVID under control, and raises questions about whether other nations would be willing – or able – to follow the same draconian steps.
The post FDA Renames Newly Approved Pfizer Vaccine: ‘Comirnaty’ + More appeared first on Children’s Health Defense.
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