FDA Plans ‘Sprint’ to Accelerate Review of Pfizer Vaccine for Full Approval + More
FDA, Under Pressure, Plans ‘Sprint’ to Accelerate Review of Pfizer’s COVID Vaccine for Full Approval
Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizer’s application for the formal approval of its COVID-19 vaccine, a senior agency official told STAT.
Pfizer’s vaccine is currently cleared under a so-called emergency use authorization, which allows the company to sell the vaccine for as long as COVID-19 is considered a public health emergency. But with COVID-19 still raging, and its spread now fueled by the Delta variant, lawmakers and prominent health experts have urged the FDA to expedite full approval of Pfizer’s vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and in giving businesses and other entities a stronger legal foundation to impose vaccine mandates.
Scientist: ‘What We’re Seeing Is Virus Evolution 101’ — Delta Variant More Transmissible, Not More Deadly
The Centers for Disease Control and Prevention (CDC) on July 27, issued an update on breakthrough infections, stating they “happen in only a small proportion of people who are fully vaccinated, even with the Delta variant.”
The CDC’s statement, however, stands in contrast to what the director of Israel’s Public Health Services told viewers of the CBS program “Face the Nation” on Sunday — that 50% of new infections reported in Israel are from fully vaccinated people.
Delta Infections Threaten Herd Immunity Vaccine Strategy
Epidemiologists are adjusting their expectations for the future course of the pandemic after data from a recent outbreak in Massachusetts in the U.S. suggest that while vaccination remains highly protective against the worst consequences of infection, it may not be sufficient on its own to stop the spread of the delta variant.
Testing conducted among Massachusetts residents during an outbreak in Provincetown, a popular weekend getaway spot, from July 3 to 17 found that 75% of those infected were fully vaccinated, in a state where 69% of adults were fully vaccinated.
FDA Authorizes COVID Antibody Treatment as Preventive After Exposure
People at considerable risk of developing severe COVID-19, including millions of Americans with compromised immune systems, now have the option of receiving a preventive monoclonal antibody treatment if they have been or are at risk of being exposed to the coronavirus.
The Food and Drug Administration’s action on Friday brings hope to the estimated 3 percent of Americans who are immunocompromised, including those with autoimmune diseases, HIV patients, cancer patients and organ transplant recipients, who may still be vulnerable to COVID even after being fully vaccinated.
This is the first time an injectable coronavirus antibody treatment has been approved for use as a prevention of COVID after someone has been exposed to the virus.
International System Makes It Easier for Healthcare Professionals, Consumers to Report Vaccine Injuries
Children’s Health Defense reported:
Children’s Health Defense (CHD) has joined with Doctors for COVID Ethics and other organizations around the globe to encourage and make it easy for healthcare professionals and vaccine recipients to report injuries and adverse reactions to any vaccines, including COVID vaccines.
CHD and Doctors for COVID Ethics urge all healthcare professionals who are aware of a vaccine adverse event, and anyone who suspects they have suffered any kind of adverse side effect — from any vaccine — to report these injuries. This information is critical in the assessment of vaccine safety.
Gene Splicing Pathogens to Make Biological Weapons Is Illegal — But Nobody Is Enforcing the Law
Brandeis University scientists are making dramatic progress with techniques for “gene splicing” — modifying the genetic makeup of organisms.
This work includes bioengineering pathogens for medical research, techniques that also can be used to create deadly biological weapons. It’s an overlap that’s helped fuel speculation that the SARS-CoV-2 coronavirus was bioengineered at China’s Wuhan Institute of Virology and that it subsequently “escaped” through a lab accident to produce the COVID-19 pandemic.
Lilly’s COVID Drug Reduces Death Risk in Patients on Ventilator
Eli Lilly and Co. said new data from a Phase 3 trial showed its COVID-19 drug, baricitinib, was shown to reduce deaths in patients receiving mechanical ventilation.
The study, which involved a cohort of 101 adult patients, found those on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who were given the drug and standard of care were 46% less likely to die by day 28 compared to those who received a placebo and standard of care.
Those Virus Sequences That Were Suddenly Deleted? They’re Back
The New York Times via Yahoo!News reported:
A batch of early coronavirus data that went missing for a year has emerged from hiding.
In June, an American scientist discovered that more than 200 genetic sequences from COVID-19 patient samples isolated in China early in the pandemic had puzzlingly been removed from an online database. With some digital sleuthing, Jesse Bloom, a virus expert at the Fred Hutchinson Cancer Center in Seattle, managed to track down 13 of the sequences on Google Cloud.
Army Gives Pfizer $3.5B Contract to Make 500 Million COVID Vaccine Doses
The Pentagon announced Monday the U.S. Army had awarded Pfizer a $3.5 billion contract to manufacture 500 million doses of its COVID-19 vaccine by the end of next year for distribution around the world.
The order matches the number of Pfizer-BioNTech vaccine doses purchased by the US government under an agreement announced last year by the Trump administration. Last month, Pfizer announced that the latest batch of 200 million doses would be delivered between October of this year and April of 2022.
Georgia DPH Provides Data on Breakthrough Cases of COVID
The Georgia Department of Public Health (DPH) has now posted a graphic detailing “breakthrough” cases of COVID-19 in the state.
A breakthrough case is when someone tests positive for COVID-19 14 days after completing their vaccination series second shot in a two-dose series or one dose in a one-dose series.
According to DPH, 4,908 people tested positive for COVID-19 after being fully vaccinated. That is 0.12 percent of the over 4.1 million fully-vaccinated Georgians.
Israeli Scientist Says COVID Could Be Treated for Under $1/Day
Ivermectin, a drug used to fight parasites in third-world countries, could help reduce the length of infection for people who contract coronavirus for less than a $1 a day, according to recent research by Sheba Medical Center in Tel Hashomer.
Prof. Eli Schwartz, founder of the Center for Travel Medicine and Tropical Disease at Sheba, conducted a randomized, controlled, double-blinded trial from May 15, 2020, through the end of January 2021 to evaluate the effectiveness of ivermectin in reducing viral shedding among nonhospitalized patients with mild to moderate COVID-19.
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