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Pfizer/BioNTech Seek FDA Nod for New COVID Boosters for Children
Pfizer Inc. (PFE.N) and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration‘s authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years.
The application comes just days after Moderna (MRNA.O) also applied for FDA authorization of its own Omicron-targeting shot in adolescents aged 12 to 17 years and children aged six to 11.
The applications represent a step towards getting children vaccinated by a so-called bivalent vaccine, which targets both the original strain of the virus and the circulating BA.4 and BA.5 subvariants of Omicron.
Did a Famous Doctor’s COVID Shot Make His Cancer Worse?
Having received two doses of Pfizer the prior spring, Michel Goldman, a Belgian immunologist and one of Europe’s best-known champions of medical research, 67, quickly went to get his third. If he was about to spend months absorbing poison as he tried to beat a deadly cancer, at least he’d have the most protection possible from the pandemic.
Within a few days, though, Michel was somehow feeling even worse. His night sweats got much more intense, and he found himself — quite out of character — taking afternoon naps. Most worryingly, his lymph nodes were even more swollen than before.
Serge, his younger brother, the head of nuclear medicine at the hospital of the Université Libre de Bruxelles, where both men are professors, spoke with Michel after having seen the scans. (“I will always remember his face, it was just incredible,” Michel told me.) The pictures showed a brand-new barrage of cancer lesions — so many spots that it looked like someone had set off fireworks inside Michel’s body. More than that, the lesions were now prominent on both sides of the body, with new clusters blooming in Michel’s right armpit in particular, and along the right side of his neck.
Michel felt a gnawing worry that his COVID booster shot had somehow made him sicker. His brother was harboring a similar concern. The asymmetrical cluster of cancerous nodes around Michel’s left armpit on the initial scan had already seemed “a bit disturbing,” as his brother said; especially given that Michel’s first two doses of vaccine had been delivered on that side. Now he’d had a booster shot in the other arm, and the cancer’s asymmetry was flipped.
‘You’re Not Alone’: Suicide Attempts Among Teen Girls Increased 50% During Pandemic, CDC Finds
Suicide is the third leading cause of death among people aged 15 to 24 in the U.S., according to the Centers for Disease Control and Prevention. Since 2019, the number of teenage girls who have been suicidal has increased 50%, according to the CDC.
Samantha Quigneaux, a family therapist at Newport Healthcare, said it’s getting worse because of “the pressure of the return to normalcy.”
“We’re trying to get back to normal when we’ve all lost out on some skills,” Quigneaux said. She says parents should look for changes in behavior, such as isolating from friends, substance use, self-harm or eating disorders. It’s “absolutely” OK to talk with your child about suicide, she said.
Exclusive: Bill Gates Reveals the Bill & Melinda Gates Foundation Aims to Run for Just 25 More Years
Bill Gates is putting a timeline on the Bill & Melinda Gates Foundation, which he co-chairs with his ex-wife, fellow billionaire Melinda French Gates. Speaking at the 2022 Forbes 400 Philanthropy Summit, the Microsoft founder-turned-philanthropist announced the foundation plans to wrap up in 25 years.
“The goal for the foundation is to run for another 25 years,” Gates said in the keynote conversation with Forbes’ Chief Content Officer Randall Lane. The aim over the next quarter-century? “Try and bring infectious disease, or all of the diseases that make the world inequitable, to bring those largely to an end, either through eradication or getting them down to very low levels.”
Gates, who predicted a pandemic back in 2015 and became famous around the world for his views on COVID-19, said he still doesn’t have a solution for misinformation and conspiracy theories. He’s even had people approach him on the street to yell at him, accusing him of tracking people with microchips.
Is COVID ‘Under Control’ in the U.S.? Experts Say Yes
President Joe Biden caused a stir in a “60 Minutes” interview on Sept. 18 when he declared that the COVID-19 pandemic is over.
There remains some debate among public health experts about whether the pandemic is “over” — or whether it realistically can ever be. There is no official arbiter for making that decision, and the word “over” suggests a finality that is not well suited for describing a pathogen that will exist in some form indefinitely.
However, we found broad agreement among infectious-disease specialists that the pandemic by now is “under control.”
Is the Pandemic Over? Pre-COVID Activities Americans Are (and Are Not) Resuming.
Two-and-a-half years into the coronavirus’s deadly spread, after nearly all government-imposed restrictions have been lifted, as many businesses urge or require workers to come back to their offices, President Biden declared last week that “the pandemic is over.” Yet even as the passion to get back to normal overrides years of caution, many Americans remain conflicted and confounded about what activities are safe.
Americans are coming out of the pandemic in the same kind of dynamic disarray that marked its beginning, with a crazyquilt of contradictory decisions about how to spend their discretionary time and money: Americans are flying again, but they’re not too keen on getting back aboard buses, subways and other public transit. Concert tickets are being snapped up, but theater tickets, not so much. In-person visits to medical doctors have returned to pre-pandemic levels, but mental health counseling remains overwhelmingly virtual.
As they choose which activities to resume, people’s priorities have varied, resulting in an economic and social hodgepodge — a country still in flux and a comeback that remains spotty.
Pfizer CEO Tests Positive for COVID for a Second Time
Pfizer Inc. (PFE.N) Chief Executive Officer Albert Bourla said on Saturday he had tested positive for COVID-19.
Bourla, 60, back in August had contacted COVID and had started a course of the company’s oral COVID-19 antiviral treatment, Paxlovid.
Bourla has received four doses of the COVID vaccine developed by Pfizer and its German partner BioNTech (22UAy.DE).
The chief executive said he has not yet taken the new bivalent booster. “I’ve not had the new bivalent booster yet, as I was following CDC guidelines to wait three months since my previous COVID case which was back in mid-August,” Bourla added.
Fight to End Virus Pandemic Takes Place on UN’s Sidelines
In four days of fiery speeches over war, climate change and the threat of nuclear weapons, one issue felt like an afterthought during this year’s U.N. General Assembly: the coronavirus pandemic.
Masks were often pulled below chins — or not worn at all — and any mention of COVID-19 by world leaders typically came at the tail-end of a long list of grievances. But on the sidelines of the annual meeting, the pandemic was still very much part of the conversation.
On Thursday, U.N. Secretary-General Antonio Guterres gathered with World Health Organization chief Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and others to discuss equitable access to COVID vaccines, tests and treatments.
Key to closing those gaps, according to Guterres, is countering misinformation about vaccines and overcoming hesitancy while also increasing testing to snuff out the potential for more variants. The world also needs early warning systems for pandemics and must ensure a well-paid and well-supplied workforce in the healthcare sector.
Drug Treatment Center Admissions Fell 23% During COVID
Admissions to drug treatment facilities fell by more than 23% during the pandemic as substance use disorders and overdose deaths rose, a new analysis published in the Journal of the American Medical Association shows.
What they found: Almost every state saw fewer patients seek treatment during 2020 than in previous years.
Native Americans accounted for the largest drop in admissions, and they also had the largest increase in overdose deaths during the pandemic.
The authors noted more work is needed to examine the reasons for the differences, including pandemic-driven shelter-in-place policies and bans on elective procedures.
Valneva in Talks With Potential Partner on Second-Gen COVID Vaccines
French drugmaker Valneva (VLS.PA) said on Monday it is in talks with a potential partner on producing an updated version of its COVID-19 vaccine that targets new variants of the disease, sending its shares up.
The French company has struggled to bring its COVID-19 vaccine to market to compete with rival products from drugmakers such as AstraZeneca, Moderna and BioNTech/Pfizer. Its shares have lost almost 80% since peaking at the end of 2021.
Valneva has won regulatory approval in the European Union and some other countries for its first-generation vaccine but said it has suspended manufacturing in light of low order levels.
