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European Regulator Recommends Pfizer’s Omicron Booster for Children
Pfizer Inc. (PFE.N) and its partner BioNTech said on Thursday the EU health regulator has recommended authorizing the use of their bivalent COVID-19 shot as a booster in children aged 5 through 11.
The Omicron-tailored vaccine is already authorized by the European Commission for individuals aged 12 years and above. The updated bivalent booster shot targets the original coronavirus strain as well as the BA.4 and BA.5 sub-variants of Omicron.
In October, European Medical Agency backed authorization of Moderna Inc.’s (MRNA.O) COVID-19 tailored booster shots for 12 and above to further vaccination campaigns in the region.
‘We’re Not Permitted to Make the Connection’: Social Worker Shares Aftermath of COVID Vaccine Injury
As a social worker known for her expertise when handling high-stress conflict management cases, Angela Loerzel Swafford figured she’d navigate her own concerns when it came to addressing her employers’ vaccination mandate last fall. And she definitely had concerns.
Like many hospitals and health systems across the nation during that time, the hospital where the 46-year-old was and is still employed required their health workers to get the jab. But Swafford suffers from a venous malformation, a condition where veins in the body develop in an unusual way. Because the abnormality can increase the risk of developing blood clots and deep vein thrombosis, she was hesitant about getting the COVID jab.
After being one of the last of her cohort of colleagues to receive the first Pfizer shot, what transpired next for Swafford was nothing short of horrifying. Four hours later she started noticing pain in her upper body and difficulty charting her patients. Driving home that night, she lost orientation as to where she was.
Once home, the strange sensations were followed by a repeated jerking of her whole body, what she said resembled Tonic-Clonic seizures. She also experienced blurred vision and terrible headaches. Ultimately, Swafford was diagnosed with a severe adverse reaction to the mRNA vaccine. “We kept running into providers in every system saying, ‘We’re not permitted to make the connection’ or ‘It doesn’t mean anything until studies support it’ or ‘It doesn’t exist until the scientific community writes about it,” recounted Swafford.
AstraZeneca No Longer Pursuing U.S. Approval for COVID Vaccine
AstraZeneca (AZN.L) is no longer pursuing U.S. approval of its COVID-19 vaccine, Chief Executive Pascal Soriot said in a media call on Thursday.
Demand for vaccines in the country is declining and the market is well served by the mRNA shots, he said.
Who Killed the COVID Vaccine Waiver?
“Is that a direct threat? I don’t know.” The adviser to the Belgian prime minister spoke calmly as they recounted a lobbying phone call from 2021, but the contents of the conversation are extraordinary.
The call was from a spokesperson for Janssen, the Belgian-founded pharmaceutical arm of Johnson & Johnson (J&J) that developed the company’s single-shot COVID-19 vaccine. According to the adviser, the spokesperson warned them that if Belgium supported a radical proposal made by India and South Africa at the World Trade Organization, then Janssen might rethink its vast billion-dollar research and development investments in Belgium.
The proposal that provoked this fear, known as the TRIPS waiver, would have allowed some intellectual property (IP) rights for COVID-19 products to be waived during the pandemic. The ambition was to give companies wanting to produce vaccines and treatments the “complete freedom to operate,” explained one official from a country that co-sponsored the proposal.
Big Pharma used its vast lobbying and influencing efforts to try to kill a proposal that threatened the very tenets of the industry. Top industry executives enjoyed direct access to senior officials within the EU, which was opposed to the proposal from the very start and encouraged potentially rogue member countries, including Italy and France, to fall into line.
And the U.S., after a dramatic late intervention in favor of a waiver for vaccines, eight months after the proposal had been tabled, failed to follow through as the Biden administration came under pressure from industry and Congress, as reported by the Intercept.
Keeping Your Blood Pressure Below This Number Reduces Risk of Severe COVID, Study Finds
High blood pressure is a known risk factor for a bout of COVID-19 severe enough to raise the specter of hospitalization and death. In fact, research has shown having high blood pressure doubles the risk of having a severe case of COVID, even if you are fully vaccinated and boosted.
But what is considered a high enough blood pressure reading to trigger that risk? To date, scientists haven’t been sure. Now, a new study out of England published Wednesday in the journal PLOS One has answered that question.
“We found that in those with diagnosed hypertension, the risk of COVID-19 significantly increased once the high number exceeded 150 mmHg or the low number exceeded 90 mmHg compared to a target blood pressure (120-129/80-89 mmHg),” said lead author Holly Pavey, a doctoral student at the University of Cambridge in the United Kingdom who is funded by the British Heart Foundation, via email.
The research found people with this level of uncontrolled high blood pressure are more likely to be admitted to the hospital and die from a COVID infection, regardless of other known risk factors such as age, ethnicity or obesity.
Sanofi, GSK Score Late Win With EU COVID Booster Approval
Sanofi (SASY.PA) said on Thursday it won European Union approval for its COVID-19 vaccine booster, jointly made with British partner GSK (GSK.L), after a drawn-out development effort that saw the pair fall behind now-dominant vaccine suppliers.
The shot with the brand name VidPrevtyn Beta can be given to people who have already had a primary course of vaccination from other approved shots, the French drugmaker and the European Medicines Agency said in separate statements.
Shipments are ready to be distributed to European countries under advance purchase agreements, Sanofi said. The company said last year that the European Union and Britain had ordered a combined 75 million doses of the shot, contingent on approval.
The shot is based on lab-made viral proteins provided by Sanofi and an adjuvant ingredient from GSK that increases the immune response. By contrast, approved mRNA shots instruct human cells to produce viral proteins that alarm the immune system.
Repeat COVID Is Riskier Than First Infection, Study Finds
The risk of death, hospitalization and serious health issues from COVID-19 jumps significantly with reinfection compared with a first bout with the virus, regardless of vaccination status, according to a study published on Thursday.
“Reinfection with COVID-19 increases the risk of both acute outcomes and long COVID,” said Dr. Ziyad Al-Aly of Washington University School of Medicine in St. Louis. “This was evident in unvaccinated, vaccinated and boosted people.”
The findings were drawn from U.S. Department of Veterans Affairs data collected from March 1, 2020, through April 6, 2022, on 443,588 patients with one SARS-CoV-2 infection, 40,947 with two or more infections, and 5.3 million noninfected individuals. Most of the study subjects were male.
New Yale Study Finds Promising Results With Nasal COVID Vaccine
A nasal booster vaccine could be key for preventing COVID-19 transmissions, according to a new study published by Yale researchers.
The research team — led by Benjamin Goldman-Israelow, a YSM assistant professor, and Tianyang Mao, a YSM graduate student — hopes to prevent the COVID-19 vaccine’s efficacy from waning over time with their nasal vaccine, called “Prime and Spike.” Immunity from the intranasal vaccine would build off of the initial vaccination to help produce mucosal immunity — immunity specifically located in the nose, respiratory tract and lungs.
The nasal vaccine — which would be administered as a booster shot after an initial intramuscular vaccination — is a subunit vaccine, meaning it delivers a part of a COVID-19 spike protein to prime the body for infection.
This is where the name “Prime and Spike” comes from — the “prime” refers to the intramuscular vaccine “priming” the body for the “spike” protein delivered through the nasal vaccine.
U.S. FDA Panel Votes Against Veru’s COVID Pill
A panel of outside advisers to the U.S. health regulator on Wednesday voted against authorizing Veru Inc’s (VERU.O) drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns over efficacy and safety data being based on a small trial.
The panel voted 8-5 against the oral drug sabizabulin’s usage and hinted that Veru gather additional data, preferably from a larger sample, regarding the drug’s ability to treat COVID-19.
The unfavorable vote is a setback for Veru in its effort to develop a COVID-19 treatment. The company was originally testing sabizabulin, which prevents tumor cells from multiplying, as a treatment for prostate cancer.
During the meeting, other issues with sabizabulin’s data were also discussed, such as the lack of clarity over a relevant patient population and the high rate of deaths in a placebo group, which the reviewers had previously flagged.
FDA Authorizes IL-1 Drug for Hospitalized COVID Patients — Anakinra Indicated for Patients With Pneumonia Who Are at Risk of Severe Respiratory Failure
The FDA has issued an emergency use authorization (EUA) for anakinra (Kineret) injection for the treatment of COVID-19 in certain hospitalized adults.
These patients include those with pneumonia who require supplemental oxygen (low- or high-flow) and are at risk of progressing to severe respiratory failure and are likely to have an elevated plasma soluble urokinase plasminogen activator receptor.
Anakinra is an interleukin-1 (IL-1) receptor antagonist that is currently FDA-approved for the treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes and deficiency of IL-1 receptor antagonists.
