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Lawyer Linked to RFK Jr. Slams Polio Vaccine Claims
An attorney advising Robert F. Kennedy Jr. criticized The New York Times and other media outlets for publishing a claim that the Trump ally wants to eradicate approval for the polio vaccine. Attorney Aaron Siri joined Fox News on Tuesday to clarify his statements after it was widely reported he advised Kennedy, who President-elect Trump tapped to lead the Department of Health and Human Services, to pause distribution of several vaccines.
“It’s totally false to say that the petition sought to revoke the polio vaccine, as if the petition intended to make it so that Americans couldn’t get the polio vaccine,” Siri said. “It was for only one of six licensed polio vaccines.” Siri noted that he filed a petition on behalf of a separate client, not Kennedy, and it was specifically for a “new polio vaccine” licensed in 1990.
Siri went on to defend Kennedy, who has made several anti-vaccine comments in the past. “He doesn’t want to get rid of any vaccines. Mr. Kennedy has made very clear, he just wants to make sure that there’s transparency and that there’s proper science,” Siri said.
Health Workers Think COVID, Flu Vaccines Safe and Effective, but Many Remain Hesitant, Global Survey Shows
A survey of more than 7,700 healthcare workers, or HCWs, in 12 countries in 2022 and 2023 finds that respondents agreed that COVID-19 and influenza vaccines are safe, effective, and useful, yet 1 in 5 reported moderate or strong COVID-19 vaccine hesitation. For the study, published in Public Health, a team led by researchers from the World Federation of Public Health Associations in Geneva surveyed 7,793 HCWs through the web platform SurveyMonkey from October 2022 to April 2023.
Participants had a median age of 44 years, and 68% were women. The 12 countries were Australia, Brazil, Canada, China, France, Germany, India, Italy, New Zealand, Spain, the United States, and the United Kingdom.
The study authors noted that vaccine reluctance was detected worldwide before the pandemic, but the introduction of COVID-19 vaccines has significantly worsened the issue. “Reluctant HCWs not only put their own well-being and that of their patients at risk, but also undermine confidence in vaccines, leading to lower vaccination coverage among patients and communities,” they wrote.
Aaron Rodgers Takes Jab at Critics of His Game, Telling Them to Reveal Their Vax Status First
New York Jets QB Aaron Rodgers took a jab at critics of his game and said they should first reveal their vaccine status so that everything said after that can be “put in the right light.” During ESPN’s “The Pat McAfee Show” on Tuesday, Rodgers said before journalists, sportscasters, broadcasters, etc, discuss the status of his game or his quarterbacking skills, they need to state the status of their COVID-19 vaccine.
“Say whatever the f*** you want about me. But just before you do it, whether you state your name, or your accolades … just state your vax status,” Rodgers explained. “So that anything you say afterwards gets put in the right light.” “Because then when you say things about me, people can at least be like, ‘Oh, you are captured by the multi-billion dollar propaganda pysop and you are still upset about it,’” he added. “Just so everybody knows where you are coming from. Everybody knows, okay cool, you are twice-vaxxed Moderna with three boosters shots, and then … say what you want to say, I don’t care, whatever.”
Russia to Launch Free Cancer Vaccine in 2025
The Russian Ministry of Health has announced that it has developed a vaccine against cancer that will be distributed to Russian patients for free from early 2025. According to TASS, the Russian state-owned news agency, Andrey Kaprin — the General Director of the Radiology Medical Research Center of the Russian Ministry of Health — recently announced the development on Russian radio.
The vaccine will apparently be used to treat cancer patients, rather than given to the general public to prevent cancer — and it will be personalized to each patient. The Director of the Gamaleya National Research Center for Epidemiology and Microbiology in Moscow, Alexander Gintsburg, previously told TASS that the vaccine could suppress tumor growth and stop cancer from spreading.
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FDA Grants Fast Track Tag to SNY’s Two COVID & Flu Vaccine Candidates
Sanofi SNY announced that the U.S. Food and Drug Administration has granted a Fast Track designation to two combination vaccine candidates to prevent influenza and COVID-19 infections in people aged 50 years and above. NCT06695117, the first vaccine candidate, combines SNY’s influenza protein-based trivalent vaccine, Fluzone High-Dose and Novavax’s NVAX adjuvanted recombinant Novavax COVID-19 vaccine, NVXC19.
NCT06695130, the second vaccine candidate, combines SNY’s influenza recombinant protein-based trivalent vaccine, Flublok with NVXC19. SNY markets Fluzone High-Dose and Flublok flu vaccines. Novavax recently signed a multi-billion dollar deal with Sanofi for its protein-based COVID-19 vaccine.
Trio of Drugmakers Issue Drug Recalls Tied to Impurity, Labeling Issues
Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling. The product pulls were reported in a recent edition of the U.S. Food and Drug Administration’s (FDA’s) weekly enforcement report, which catalogs recalls after they’ve been properly classified by the regulator.
In the case of Aurobindo, the company issued a recall of more than 100,000 bottles of cinacalcet at the 30 mg dose and more than 3,300 bottles at the 60 mg dose. The company also recalled an undisclosed number of 90 mg bottles. The drug is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.
The recall for cinacalcet, which was manufactured in India, was attributed to the presence of N-nitroso Cinacalcet impurity levels that exceeded recommended limits set by the FDA. N-nitroso compounds are considered potentially carcinogenic. The drugs in question were distributed nationwide in the U.S., and the recall has been classified as Class II, which means there is a low chance of serious injuries or death.
FDA Issues Safety Alert on Liver Disease Drug
Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, the U.S. Food and Drug Administration (FDA) said in a safety communication on Thursday. The agency’s review of a mandated clinical trial “found that some cases of liver injury in patients without cirrhosis resulted in liver transplant. This risk was notably higher for patients taking Ocaliva compared with a placebo,” the FDA said.
The FDA in 2016 granted accelerated approval to the farnesoid X receptor agonist as a second-line treatment for adults with PBC, either in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to the standard therapy or as a single agent in patients unable to tolerate UDCA.
Big Pharma’s New DTC Play: Partnering With Digital Health Providers
Eli Lilly’s recently announced plan to partner with digital health company Ro on its LillyDirect platform marks a new turning point in the direct-to-consumer push among Big Pharma companies. Ro, which launched in 2017, offers online prescriptions under the “wellness” bucket including drugs aimed at obesity, sexual health and hair loss — a model similar to digital health companies like Hims & Hers.
Lilly and Novo, the undisputed leaders in the obesity market, have been locked in a battle with pharmacies that make compounded versions of their GLP-1 medications. Under U.S. Food and Drug Administration (FDA) rules, compounded medications are allowed to be sold when the FDA-approved, brand versions are in shortage. And the FDA is currently reviewing a shortage decision on GLP-1s that has kept compounded versions on the market.
The FDA is scheduled to update its compounded GLP-1 shortage review Dec. 19, but the agency could delay that decision. In October, the FDA removed Lilly’s Zepbound and diabetes drug Mounjaro from its shortage list, requiring compounding pharmacies to stop manufacturing and selling their versions of the drugs. After a group of compounders sued, the FDA reversed its decision, leading to the current limbo.
New Clade 1b Mpox Cases Detected in Germany
According to media reports, Germany has four new clade 1b mpox cases, including two cases in school-aged children. According to a post from the infectious disease blog Avian Flu Diary, the cases are in a family that recently traveled to Africa. One person likely had close contact with a case-patient while traveling, and then spread the virus to three family members. The family lives in the Rheinisch-Bergischer district, near Cologne.
Health officials from the district are working with the Robert Koch Institute to contact the schools and places of employment of the family and monitor contacts for symptoms.
Clade 1b began spreading last year in the Democratic Republic of the Congo and has since been found in dozens of African countries as well as in Sweden, Thailand, India, the U.S., the United Kingdom, and Canada.
Germany had reported one other clade 1b case in October, and the patient recovered fully. This strain of mpox is considered more virulent and transmissible than the clade 2 strain that caused a global outbreak of the virus primarily among men who have sex with men in 2022. Clade 1b can be spread through close contact with an infected person.
