EU Finds J&J Shot Possibly Linked to Another Rare Clotting Condition + More
EU Finds J&J COVID Shot Possibly Linked to Another Rare Clotting Condition
The European Union’s drug regulator on Friday identified a possible link between rare cases of blood clotting in deep veins with Johnson & Johnson‘s (JNJ.N) COVID-19 vaccine and recommended the condition be listed as a side-effect of the shot.
The European Medicines Agency also recommended that immune thrombocytopenia (ITP), a bleeding disorder caused by the body mistakenly attacking platelets, be added as an adverse reaction with an unknown frequency to the J&J vaccine product information and to AstraZeneca‘s (AZN.L) vaccine.
‘Human Error’ Caused Contamination of Moderna Vaccines in Japan, Distributor Takeda Says
Japan’s Takeda Pharmaceutical — which distributes the Moderna shot in Japan — on Friday blamed “human error” as the cause of metal contaminants that were found in some batches of the Moderna COVID-19 vaccine which led to the withdrawal of 1.63 million doses of the mRNA shot from Japan in August.
After the suspension, Japanese health officials are investigating the deaths of at least two men who had been inoculated with doses from the suspended lot. While experts were skeptical about the possibility of the contaminants causing the two deaths, there were fears it could help fan vaccine hesitancy in the country. According to a study published by the medical journal Lancet last year, Japan has one of the lowest rates of confidence in vaccine safety and effectiveness in the world.
Merck Says Experimental Pill Cuts Worst Effects of COVID
Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.
If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major step forward in global efforts to control the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.
COVID Vaccine Makers Fall as Merck’s Pill Shines in Trial
Shares of Moderna Inc and Pfizer Inc. slid on Friday after data from a late-stage study showed a COVID-19 pill from Merck & Co reduced chances of hospitalization or death among patients at risk of severe disease.
Merck leads the race in developing the first oral antiviral medication for COVID-19, while rivals such as Pfizer Inc. and Swiss pharmaceutical Roche Holding AG, and partner Atea Pharmaceuticals are running late-stage trials of their own.
Some Wall Street analysts said Merck’s positive data and the promise of an oral drug that can be taken at home could change the public perception of risks associated with COVID-19.
‘COVID Will Become Manageable’: BioNtech Co-Founder Says the Virus Will Be With Us for Years
The co-founder and chief medical officer of BioNTech, the German firm which developed a COVID-19 vaccine alongside Pfizer, told CNBC that the world “should not live in fear” of the virus.
“COVID will become manageable. It already has started to become manageable” Dr. Ozlem Tureci said in the latest episode of “The CNBC Conversation.” However, she added that we will “need to go back to a new normality, because this virus will accompany us for, still, some years.”
Kavanaugh Tests Positive for COVID, Has No Symptoms
Justice Brett Kavanaugh on Thursday evening tested positive for COVID-19 but was without symptoms of illness, a Supreme Court spokesperson said.
Kavanaugh, 56, has been fully vaccinated since January, making his a so-called breakthrough case. His last negative test came Monday prior to the justices’ in-person conference.
People Are Getting Moderna ‘Boosters’ Anyway — Most Are Getting Them at Pharmacies, Not in Doctors’ Offices
Several sources have told MedPage Today that they’ve received a “booster” shot of Moderna, even though the vaccine isn’t yet authorized for this indication.
These are people who don’t fit the specific criteria for being immunocompromised that would qualify them for a third dose of the vaccine. Some of them are over 65 but didn’t get their primary series with Pfizer. The majority got their shots at a pharmacy, not in a doctor’s office.
Fauci Pressed if He Should ‘Step Aside’ as an ‘Impediment to Public Health’: ‘People Won’t Listen to You’
Dr. Anthony Fauci faced a tough grilling over whether or not he should step aside as his critics view him as a deterrent in the Biden administration’s ongoing effort to vaccinate Americans.
During Wednesday’s appearance on Hugh Hewitt’s radio show, Fauci was confronted by a list of COVID-era “controversies,” including the pause of the Johnson & Johnson vaccine, the ivermectin debate, the avoidance of natural immunity as well as his “noble lie” discouraging Americans from wearing masks in the early months of the pandemic to prevent an N95 shortage.
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