FDA Paves Way for Pfizer COVID Vaccinations in Young Kids + More
FDA Paves Way for Pfizer COVID Vaccinations in Young Kids
The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.
The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.
One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards.
FDA Adviser Explains Why He Abstained From Vote on Pfizer’s COVID Vaccine for Young Children
All 17 others voted to advise the administration, or the FDA, to authorize the jab for children between the ages of 5 and 11. The agency already supported doing so and is expected to formalize the authorization soon. The Centers for Disease Control and Prevention would then decide which children should get the shot.
The vote was preceded by nearly eight hours of discussions and presentations, with multiple members expressing concern about the scant data on how the vaccine will affect the age group.
But Dr. Michael Kurilla, an expert on infectious diseases and pathology who directs a division inside the National Institutes of Health, was the only one who didn’t support the recommendation.
COVID Vaccine Approval Will Endanger Over Millions of Young Children
The East County Gazette reported:
In yesterday’s meeting, Vaccines and Related Biological Products Advisory Committee (VRBPAC) members considered whether it would be appropriate to approve Pfizer’s experimental COVID vaccine for children under the age of 5 to 11.
A hearing and vote on the same experimental vaccine will be held on Nov. 2 and 3 by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP).
However, Robert F. Kennedy, Jr., Chairman of Children’s Health Defense (CHD), and Meryl Nass, MD wrote to all members of the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) noting the recent peer-reviewed research indicating that children are unlikely to suffer hospitalization and death from the COVID-19 virus.
New Monoclonal Antibody Sharply Reduces Risk of Severe COVID Outcomes
The monoclonal antibody sotrovimab reduced the risk of hospitalization or death from COVID-19 by 85% compared with placebo, according to an interim analysis of a phase 3 clinical trial published yesterday in the New England Journal of Medicine.
In the double-blind, multicenter trial, non-hospitalized patients with symptomatic COVID-19 and at least one risk factor for disease progression were randomly assigned to receive either 500 milligrams of sotrovimab, a pan-sarbecovirus monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, or placebo.
Was NIH-Funded Work on MERS Virus in China Too Risky? Science Examines the Controversy
Questions related to the frustrating search for the origin of the COVID-19 pandemic keep creating commotion. Last week, the U.S. National Institutes of Health (NIH) placed one of its grantees, and itself, in the hot seat when it told Congress in a letter that the EcoHealth Alliance in New York City had failed to promptly report potentially worrisome results from a virology experiment done by a collaborator in China.
In a progress report for one of its grants, EcoHealth had mentioned an altered bat coronavirus made mice sicker than expected, a discovery it should have notified the agency of immediately, NIH asserted in a letter to Congress.
Latest Lancet Study Exposes Limits of Vaccines at Preventing COVID Infection
The Lancet has just released another study comparing the efficacy of COVID vaccines to the efficacy of protection provided by previous COVID infections. Their conclusion: while vaccines lower the risk of infections with the Delta variant within households, those who are fully vaccinated are still vulnerable to a ‘breakthrough‘ infection if somebody they live with gets infected.
What’s more, people who have been vaccinated against COVID can be equally as infectious as the unvaccinated, the study showed.
The new study, which was published Thursday in the Lancet, the British medical journal that published some of the earliest research on COVID, is one of few to use detailed infection data from actual examples of household transmission, and it showed that — as we noted above — the viral loads of both vaccinated and unvaccinated patients infected with COVID are “broadly similar.”
PRAC Assessing Further Data on Risk of Myocarditis and Pericarditis With mRNA Vaccines
European Medicines Agency reported:
EMA’s safety committee (PRAC) is assessing further data providing more information on the risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna).
Myocarditis and pericarditis are inflammatory conditions of the heart. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain.
The committee has now asked the companies that market these vaccines to perform an in-depth review of all published data on the association of myocarditis and pericarditis, including clinical trial data, data from the literature and data available in the public domain.
G20 Set to Commit to Cutting Period to Develop Vaccines in Pandemic — Draft
Leaders of the world’s 20 largest economies are set to commit to supporting efforts to shorten to 100 days the period needed to develop new vaccines, drugs and tests in a pandemic, according to a draft joint document.
In normal circumstances developing vaccines takes more than a decade, but the COVID-19 pandemic spurred an unprecedented rush in research, trials and regulatory procedures that made it possible to have vaccines ready in less than a year.
Now G20 leaders want that period to be cut further.
COVID Cases Are Down 60% From Delta Peak. Still, Be Vigilant Heading Into Winter, CDC Director Says
Rates of COVID-19 cases, hospitalizations and deaths have sunk significantly in the U.S. since a wave driven by the highly contagious Delta variant peaked in September.
The U.S. has averaged 69,011 new cases a day over the last week — down about 60% from a peak in a Delta-driven wave (127,531) reached in mid-September, according to Johns Hopkins University data.
Breakthrough Infections Can Lead to Long COVID, New Research Suggests
Fully vaccinated people infected with the novel coronavirus can experience long-term symptoms, an experience otherwise known as “long COVID-19.”
Those who experience “breakthrough” infections — which happen when fully vaccinated people get COVID-19 — can experience persistent symptoms of COVID-19 long after infections, according to researchers at Oxford University.
The researchers in the U.K. reviewed data on nearly 20,000 U.S. COVID-19 patients for the study. Half of those patients were fully vaccinated. The study — which has not been peer-reviewed — has been published on medRxiv.
Exclusive: Tens of Millions of J&J COVID Shots Sit at Baltimore Factory — Sources
An estimated 30 million to 50 million doses of Johnson & Johnson‘s (JNJ.N) COVID-19 vaccine made early this year sits idle in Emergent BioSolutions Inc’s (EBS.N) plant in Baltimore awaiting a green light from U.S. regulators to ship, two sources familiar with the matter said.
Emergent, a contract drug manufacturer, is waiting for the U.S. Food and Drug Administration to approve release of those doses. The agency must still inspect and authorize the plant before Emergent can ship newly manufactured drug substances, one of the sources said.
G20 Want 70% Of World Vaccinated by Mid-2022, Sets up Pandemic Task Force
Finance and health ministers from the world’s 20 biggest economies (G20) said on Friday they would take steps to ensure 70% of the world’s population is vaccinated against COVID-19 by mid-2022 and created a task force to fight future pandemics.
They could not reach agreement on a separate financing facility proposed by the United States and Indonesia, but said the task force would explore options for mobilising funds to boost pandemic preparedness, prevention and response.
The previous goal had eyed vaccinating 70% of the world’s population by the autumn of 2022.
A COVID Breathalyzer: Ohio State Researchers Develop New Test for Coronavirus
The Columbus Dispatch reported:
Wexner Medical Center researchers have created a breath test that appears to be highly accurate at rapidly screening patients for COVID-19.
The research team has applied to the U.S. Food and Drug Administration for emergency use authorization of the breathalyzer technology. Results from an initial study in patients were published Thursday in the medical journal PLOS ONE.
While the “gold standard” for diagnosing COVID is a PCR test that takes sometimes days to process in a lab, the breath test was able to detect the virus in patients within seconds, Dr. Matthew Exline, lead researcher and director of critical care at the medical center said in a press release.
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