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Moderna’s updated Covid booster appears to increase the immune response to omicron subvariants BA.4 and BA.5, as well as another subvariant, called BQ.1.1, that's gaining ground in the United States, the company said in a release Monday. The results are based on blood samples taken from 511 adults who got the updated booster, which targets BA.4 and BA.5, along with the original coronavirus strain, in a single shot. In people who got the updated booster, neutralizing antibodies against BA.4 and BA.5 were about fivefold higher in those with a previous Covid infection and sixfold higher in those without a documented infection, the company said. Moderna also said an additional analysis of 40 people found the updated booster demonstrated “robust neutralizing activity” against the subvariant BQ.1.1, though the response wasn’t as strong as what was seen against BA.4 and BA.5. Earlier this month, Pfizer and BioNTech said their updated booster shot generated a stronger immune response against BA.4 and BA.5 compared with their original Covid vaccine.

In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer's Covid vaccine. Courtesy Da’Vion MillerMiller is one of a very small group of people in the United States who have experienced myocarditis following vaccination with the Pfizer-BioNTech or the Moderna Covid vaccines based on mRNA technology. Video: CDC says waiting longer between Covid vaccine doses could reduce myocarditis risk. Cooper joined an expert advisory panel formed by Moderna to monitor its Covid vaccine safety. The Pfizer study will include people who were previously hospitalized with vaccine-associated myocarditis, and it will also follow those who were more recently diagnosed.

☆ California expected to partner with nonprofit Civica Rx to produce its own low-cost insulin, sources say
▼ + stars: | 2022-11-11 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

California plans to partner with Civica Rx, a nonprofit generic drug company, in the state's effort to produce its own low-cost insulin, according to two people familiar with the matter. Gavin Newsom announced in July that he had approved a budget that would allocate $100 million to allow the state to begin making its own insulin. It'll be the first state to produce insulin for its residents, which experts see as a road map for other states to make the lifesaving medication more affordable. California expects to announce the partnership in mid-December, although it hasn't been finalized and the state could select a different company, the sources said. A Civica Rx spokesperson didn't confirm the plan but said the company welcomes "the opportunity to partner with California."

Pfizer-BioNTech's updated booster shot generates a stronger immune response against the omicron subvariants BA.4 and BA.5 compared with the original Covid vaccine, the companies said in a release Friday. Pfizer's original vaccine formula, which was first administered to older adults in December 2020, was designed to target the original coronavirus strain. The updated booster shot is designed to target the original virus strain, as well as BA.4 and BA.5, in a single shot. Two independent studies posted online late last month suggested that the updated shots do not offer better protection against the new omicron subvariants than the original vaccines do. The new findings may hint that the updated booster is better than the original vaccine, but not by much, said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

☆ RSV vaccine for kids: Pfizer shot for pregnant women protects infants from severe illness
▼ + stars: | 2022-11-01 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +5 min

An experimental RSV vaccine for pregnant women from Pfizer is effective at protecting newborns against severe illness for at least six months, the company said in a press release Tuesday. The vaccine was also about 70% effective against severe infections through the first six months of life. Pfizer said in a statement that it is currently not conducting an RSV vaccine trial in infants. Pfizer's RSV vaccine could be "a major step forward so that we can attack this last really bad communicable disease of the neonatal period," Schaffner said. Aside from pregnant women, Pfizer is testing its vaccine in older adults, who are also at risk for severe RSV infections.

That there is no RSV vaccine for kids is not for lack of interest, experts say. But a trial gone wrong many years ago and a tricky target protein have made developing an RSV vaccine difficult. Researchers’ attempts to develop an RSV vaccine go back decades, according to Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children's Hospital. In August, Pfizer announced that its experimental RSV vaccine was nearly 86% effective in preventing severe illness in adults ages 60 and older. GSK, however, said it abandoned its efforts last year to develop a pediatric RSV vaccine, because trials suggested it wasn't effective.

Pediatric cases of the flu and RSV, or respiratory syncytial virus, are on the rise. Here are the signs and symptoms to look out for if your child has a respiratory virus. Does my child have RSV, Covid or the flu? Early symptoms of Covid, RSV and the flu can look similar for many children, including:CongestionCoughRunny noseMuscle achesFeverHeadacheA sore throat, Moffitt said, could be a sign of Covid, as doctors have noticed that infections with omicron subvariants often begin with sore throats. Hotez also urged parents to get their children vaccinated against Covid and the flu.

Pfizer plans to sell the Covid vaccine it developed with BioNTech at $110 to $130 per dose for teens and adults once the U.S. government stops paying for them, the drugmaker said Friday. Since the start of the pandemic, the government has provided Americans with free Covid tests, vaccines and treatment, through a combination of funding from Congress and other government programs. The government has already stopped providing free Covid tests. A CDC advisory committee voted Wednesday to add Covid vaccines to the Vaccines for Children program, a federal plan that provides free vaccines to children eligible for or covered by Medicaid. Pfizer said it also plans to provide free vaccines to people without insurance through its patient assistance program.

☆ FDA panel recommends revoking the approval of controversial drug for preterm births
▼ + stars: | 2022-10-19 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The trial found that the drug failed to reduce the risk of preterm births or produce better health outcomes for newborns. When a 2019 trial showed that the drug produced no benefits, the same FDA advisory panel voted to revoke the drug's approval. What's more, "retaining Makena’s approval likely hinders study of more promising treatments for preterm birth," FDA scientists wrote. It also proposed a partial withdrawal of the drug, making the drug only available to women at the highest risk of preterm birth.

The cost of insulin remains a barrier for many Americans with diabetes who depend on the drug, research published Monday suggests. It was the first time that the CDC had included questions about insulin use, though concerns about sky-high insulin prices have been reported for years. Meanwhile, those with public health coverage, such as Medicaid and Medicare, had the lowest rates of rationing. According to the American Diabetes Association, people with type 1 diabetes need, on average, two to three vials per month. He said the "most ambitious" proposal he would like to see in the U.S. is universal health coverage with no copays for consumers.

☆ Pfizer-BioNTech releases first human results on updated booster, citing an increase in antibodies
▼ + stars: | 2022-10-13 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

The results are based on blood samples taken from adults one week after they received the updated booster. The FDA also authorized Moderna's updated booster based on similarly limited data. The FDA authorized the updated shots based on studies in mice — plus human trial results from a similar booster that targets the original omicron strain, called BA.1. At the time, Dr. Peter Marks, the FDA's top vaccine regulator, said the agency hoped the updated vaccines will provide stronger protection against symptomatic disease than the older vaccines. Moderna didn't immediately respond to a request for comment about when it will release new data on its updated booster.

The Food and Drug Administration on Wednesday authorized updated Covid booster shots that target the omicron variant of the virus for young children. The decision will now go to the Centers for Disease Control and Prevention, which could issue its final recommendation on the updated shots within hours. Only about 31% of children ages 5 to 11 have received two doses of any Covid vaccine, according to CDC data. Experts say it's important for people to receive the updated shots because the nation could face yet another potential wave of Covid infections this winter. The boosters are important because data has shown that any Covid vaccine greatly decreases the risk of severe outcomes from the virus, said O’Leary.

☆ Colonoscopies may not be as effective as thought, study suggests. Doctors disagree.
▼ + stars: | 2022-10-11 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +7 min

What did the colonoscopy study find? With longer monitoring, the results could show a larger reduction of colon cancer risk, said Brawley of Johns Hopkins. Cancer experts reached Monday said their recommendation for colorectal cancer screening remains the same: Regular colonoscopies are key to preventing colon cancer and finding it early. In the U.S., “we have exaggerated the benefits of colon cancer screening,” Brawley said. “We have good studies that show that colon cancer screening is effective.

Amid concerns about Russian President Vladimir Putin’s recent nuclear threats came a bit of startling news: The U.S. Department of Health and Human Services said Tuesday that it spent $290 million on a drug to treat radiation sickness. Nplate, manufactured by U.S. drugmaker Amgen, was approved by the Food and Drug Administration in 2021 to treat injuries caused by acute radiation syndrome, also known as radiation sickness. Amgen will maintain the supply of the drug, an approach the HHS says lowers costs for taxpayers and allows the drug to be used in the commercial market before it expires. Chris Meekins, former deputy assistant secretary for preparedness and response at HHS, said that he sees no cause for alarm over the purchase. Greg Burel, the former director of the Strategic National Stockpile, agreed, saying that he doesn't think the HHS' purchase of the drug is related to the Russian invasion of Ukraine in February.

The Japanese drugmaker Eisai said Tuesday its experimental drug for Alzheimer’s disease helped slow cognitive decline in patients in the early stages of the illness. The company said that in a phase 3 clinical trial, the drug, called lecanemab, slowed cognitive decline by 27% after 18 months. The results may offer renewed hope to Alzheimer’s patients after the U.S. drugmaker Biogen’s botched rollout of its drug, Aduhelm, last year. Biogen partnered with Eisai in the commercialization of the new drug, although Eisai led its development and the phase 3 trial. Two similar drugs — from Roche and Eli Lilly — are expected to release late-stage clinical trial results over the next few months.

☆ The Inflation Reduction Act aims to lower drug costs — but here’s how Big Pharma could get around it
▼ + stars: | 2022-09-20 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +7 min

The Inflation Reduction Act is set to lower drug prices for millions of people in the United States — but experts fear pharmaceutical companies could exploit loopholes in the bill, ultimately keeping prescription costs high for many. The tactics may ultimately threaten the law’s ability to lower drug costs for consumers. Higher prices for new drugsOther experts are concerned about how companies might abuse the inflation rebate rule in the health law. The provision, which takes effect next year, imposes a rebate on drug manufacturers that raise the prices of their medications faster than inflation. By releasing new drugs at higher prices, drug companies will be able to make up for any lost revenue that they would normally receive from steadily raising prices each year, she said.

Patient advocates were disappointed with Sunday’s vote — Republican senators blocked the $35 insulin cap for private insurers — and expressed hope that federal and state measures could be included in legislation down the road. Clayton McCook of Edmond, Oklahoma, is among those who support capping the cost of insulin for people with private health insurance. A federal insulin cap for private insurance would have made “a huge difference to our family,” he said. “This year, with an evenly divided Senate, the insulin cap for people with private insurance didn’t secure enough votes,” Neuman said. McCook also advocated for changes besides a cap on insulin costs, saying Congress pass legislation that would lower the list price.

As yet another Alzheimer's drug targeting plaque buildup in the brain fails to improve cognition in patients, leading scientists said a significant shift is underway in the search for effective treatments for the disease. By 2050, that number is projected to rise to nearly 13 million, according to an estimate from the Alzheimer’s Association. Alzheimer’s disease is often referred to as “Type 3 diabetes,” a brain-specific form of diabetes that is the result of the brain’s neurons lacking glucose, said John Didsbury, the CEO of T3D Therapeutics. Data from the longest-ever phase 3 trial of exercise on cognition released at the conference on Tuesday found that exercise may stall cognitive decline in Alzheimer’s patients. He said it’s only a matter of time before we see more research discoveries that show potential for slowing Alzheimer’s disease, possibly within the next year or two.

The 26-year-old had been recently removed from his parents' health insurance plan and was about $300 short of the $1,300 he needed to pay for his insulin medication, his mother said. Though drugmakers often offer programs that can lower the out-of-pocket cost of insulin for both insured and uninsured patients, the financial burden can still be devastating for some. Why insulin remains unaffordableBut why does insulin — a medication that’s been around for more than 100 years — remain unaffordable for many people in the U.S.? Meanwhile, state and federal lawmakers are pushing for legislation that would lower the out-of-pocket cost for patients on insulin. She is pushing for more states to adopt the Alec Smith Insulin Affordability Act, which provides an emergency 30-day supply of insulin to patients for $35.

☆ WHO is investigating 1,716 health workers in China infected with coronavirus
▼ + stars: | 2020-02-14 | by ( Berkeley Lovelace Jr. | ) www.cnbc.com time to read: +4 min

World health officials are working with Chinese authorities to determine when the 1,716 health workers in the country were infected with the COVID-19 coronavirus, World Health Organization officials said Friday. Earlier in the day, China's National Health Commission said that 1,716 health workers in the country had been infected with the coronavirus and six of them have died. It was the first time China published figures specifically relating to infected medical personnel. She said there are currently no health workers in the U.S. that have contracted the virus. World health officials have said the respiratory disease is capable of spreading through human-to-human contact, droplets carried through sneezing and coughing and germs left on inanimate objects.

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