Free biotech stocks directory, pharma stocks, telemedicine stocks ...
This Vaccine Protects Against Cancer—but Not Enough Boys Are Getting It
It wouldn't be an overstatement to call the HPV vaccine a medical miracle.
"It's like the gift that keeps giving," says Mark Jit, a professor of vaccine epidemiology at the London School of Hygiene & Tropical Medicine. Not only is it the sole vaccine that can prevent cancer, "we discover it's an even better vaccine as time goes on," he says.
Since its development and rollout in the mid-2010s, the HPV vaccine's prowess at heeding off cervical cancer rates has been remarkable. Over an 11-year period in the United Kingdom, cases of cervical cancer fell by 87 percent among those who received the vaccine compared to those who didn't. It's conceivable that one day, a whole form of cancer could be effectively eliminated.
And the vaccines don't just protect against cervical cancer. They can also prevent head and neck, vaginal, anal, and penile cancer, as well as protecting against genital warts in both genders. But there's the rub: Although these vaccines protect against cancers that affect both men and women, boys and men aren't offered the vaccine in two-thirds of countries where they are available. In those places, half the people who could benefit are missing out on a potentially life-saving intervention. But that's starting to change.
When the rollout of HPV vaccines was first gearing up—and their price was still high—it made sense to target the most at-risk group, says Jit, that being girls between the ages of 9 and 14. But in the intervening decade or so, the vaccines have dropped significantly in price. Over the same period, research showcasing the benefits of gender-neutral HPV vaccine campaigns has compounded. "From a social justice and equality point of view, it makes sense to vaccinate men and women," says Kit Yates, a mathematical biologist at the University of Bath. Failure to do so means men are left at risk, and this places the onus on women to protect men from HPV, rather than sharing the burden.
A barrier to wider rollout in recent years has been uneven supply: as eligible groups expanded, demand shot up. The makers of the vaccines couldn't keep up, and there was a major squeeze, meaning many low-income countries had to go without. But supply has started to ramp up again, and India—the world's largest vaccine producer—debuted its own home-grown vaccine last year.
New research has also shown that just one dose offers sufficient protection, meaning the usual two-dose regime can be halved and double the people can be included in national rollouts. "Now is the time we can start asking, actually, are there other groups that should be vaccinated?" says Jit.
A Very Common Problem
HPV, or human papillomavirus, is the everyman STI. Between 80 and 90 percent of people will acquire it at some point in their lives, typically through skin-to-skin contact. Odds are that you, reader, will probably pick up the virus—if you haven't already. Luckily, for most carriers it won't have an impact; you can be asymptomatic for your whole life.
But for a small chunk of carriers, HPV can lead to potentially fatal cases of cancer; of the around 200 types of HPV, scores are cancer-causing. HPV becomes cancerous by sneaking into the body and burrowing itself into cells, where it photocopies itself. Most infections won't take root, and your body will boot them out within a year or two. But some persistent infections can linger on, changing normal cells to abnormal cells, which can lead to cancer if untreated.
State Launches Vaccine Education Program
ALBANY, N.Y. – The New York State Department of Health is launching its fall COVID-19 and flu vaccine public education campaign, encouraging New Yorkers to protect themselves, their loved ones, and their community from respiratory viruses. The advertisements, which will run in both English and Spanish language start this week and will run for 11 weeks.
"This fall, we are once again encouraging New Yorkers to take the protective measure against respiratory viruses by getting the flu shot and updated COVID-19 vaccine," State Health Commissioner Dr. James McDonald said in a news release. "The new COVID vaccine is better formulated to target the circulating variants, just like the flu shot is targeted each year."
With children back in school and respiratory virus season on the horizon, adults and parents are encouraged to get both their annual flu shot and COVID-19 vaccine for themselves and for children aged 6 months and older.
The flu and COVID-19 are both contagious, respiratory viral infections that can have similar symptoms, making it difficult to distinguish between the two illnesses. People with chronic conditions, including those that affect the lungs and heart, young children, elderly populations, and pregnant people have a higher risk of developing serious complications from the flu and COVID-19.
Both vaccines can be given at the same time.
"With both flu and COVID-19 transmission expected to increase during the fall and winter seasons, getting both vaccines will provide meaningful protection against serious illness or hospitalization. Everyone who can should get both vaccines. And if you have a loved one in assisted living or a nursing home, encourage the facility to get them both vaccines," McDonald said.
The updated 2023-24 COVID-19 vaccine is approved by the FDA and has been reformulated to target the Omicron subvariant XBB.1.5. As most of the COVID strains currently circulating now are descendants of this variant, previous COVID vaccinations do not provide the same protection against illness from currently circulating strains like this updated formulation does.
The public campaign includes 15-second and 30-second videos in both English and Spanish:
The 30-second English language version may be viewed at https://www.Youtube.Com/watch?V=yf4OlX2U5nY.
30-second Spanish language version may be viewed at https://www.Youtube.Com/watch?V=4MBQJsYUslE.
To improve access to the COVID-19 vaccine, State Health Commissioner Dr. James McDonald has issued two standing orders to authorize licensed pharmacists to administer the Pfizer and Moderna updated COVID-19 vaccines to individuals ages five years and older without an order from a physician.
Under the Affordable Care Act, most health insurance plans will cover the cost of COVID-19 vaccines without the need for co-pays. Those who are uninsured, or whose insurance does not cover the updated vaccine, will have access to the vaccine free of charge through community health centers; local, tribal, or territorial health departments; and pharmacies participating in the HHS Bridge Access Program.
The department has the following resources to help New Yorkers make informed decisions about flu and COVID-19:
– Information about the flu is available at https://www.Health.Ny.Gov/diseases/communicable/influenza/seasonal/, including fact sheets and other downloadable materials.
– The COVID-19 webpage has information on COVID-19 symptoms & prevention, testing, and treatment.
– Information about vaccine efficacy and safety can be found at https://www.Health.Ny.Gov/prevention/immunization/vaccine_safety.
Vaccine Makers Prep For Sluggish Demand
With Evan Peng
Driving the DayPfizer CEO Albert Bourla says that demand for the company's Covid vaccine has dropped because people are experiencing "Covid fatigue" and "anti-vaccination retort."John Thys/AP
TEPID COVID VAX UPTAKE — Despite federal health authorities pushing updated Covid-19 vaccinations, manufacturers are bracing for lukewarm demand ahead of the respiratory virus season.
"We have come through the period of fear that defined the early days of Covid where everybody wanted to be vaccinated very quickly," Albert Bourla, Pfizer's CEO, said in a call with investors Monday. "We are right now in the middle of Covid fatigue where everyone wants to forget about the disease, and we are experiencing a peak of anti-vaccination retort."
The company said last week it had adjusted its predicted Covid vaccination sales for the year by $2 billion to reflect lower demand than it initially anticipated. Moderna and Novavax, which also have updated Covid shots, said they believe it is too soon to predict how many people will seek vaccinations.
As of Monday morning, about 8 million individuals have received an updated XBB Covid-19 shot, Ilse Zuniga, a spokesperson for HHS, told Prescription Pulse. The figures come from providers and distributors that have voluntarily reported vaccinations to the federal government because the Centers for Disease Control and Prevention halted Covid vaccine tracking when the public health emergency ended in May.
The mRNA shots from Pfizer-BioNTech and Moderna have been available for roughly four weeks, and Novavax's protein-based shot received a green light earlier this month. By comparison, the Biden administration estimated that roughly 13 to 15 million people ages 12 and older had received an updated vaccine at this time last year.
What about other Covid products? Pfizer said last week that its sales of the antiviral therapy Paxlovid have also dwindled, leading the company to predict the drug will bring in about $7 billion less in revenue than it initially estimated. The company will begin selling the therapy on the commercial market in November. Lagevrio, Merck's Covid antiviral, will also transition to the commercial market at that time.
"Those who are getting vaccines and medicines in the current environment are people who believe in the value of protection and treatment and will continue this treatment in the year to come," Bourla said.
IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE and to peak fall foliage season in the DMV.
Send news, tips and autumnal views to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).
TODAY ON OUR PULSE CHECK PODCAST, host Megan R. Wilson talks with POLITICO health care reporter Ben Leonard, who previews the health care policies at the center of some Senate hearings this week and describes how action on health care issues continues in the House behind the scenes despite the House speaker chaos playing out in public.
A message from 340B Health:
340B hospitals serve as a vital safety net for essential health care. 340B hospitals provide 77% of all hospital care to Medicaid patients and 67% of all unpaid hospital care in the U.S. Protecting 340B is crucial for the health of patients and communities. Learn more.
TobaccoThe White House is conducting a review of proposed rules that would ban menthol cigarettes and flavored cigars.Drew Angerer/Getty Images
MENTHOL CIGARETTE BAN AT THE WHITE HOUSE — The FDA's revised proposed rules banning menthol cigarettes and flavored cigars reached the White House on Friday for final review. After the rules go through the Office of Management and Budget, they will be formally published.
"Finalizing these two product standards remains a top priority for the FDA," Brian King, director of the FDA's Center for Tobacco Products, said in a statement to Prescription Pulse.
The rules, intended to encourage smoking cessation, had been slated to be finalized in August. It often takes roughly six weeks for the White House to conduct its final review of new regulations. It will be a year after the rule is finalized before the ban goes into place, and experts expect the tobacco industry to sue the FDA over the rules in the meantime.
Industry IntelRITE AID FILES FOR BANKRUPTCY PROTECTION — Rite Aid filed for Chapter 11 bankruptcy protection in New Jersey on Sunday amid legal battles over accusations that its pharmacies filled thousands of unlawful prescriptions for drugs, including opioids, POLITICO's Evan Peng reports. On top of those lawsuits, one of which was brought by the Justice Department in March, Rite Aid faces flagging sales and growing debt.
According to the company's bankruptcy filing, Rite Aid has more than 2,000 stores remaining open nationwide following several recent closures. In response to an inquiry, a company spokesperson confirmed that, as part of a restructuring, Rite Aid intends to close certain underperforming stores to save on rent but would not confirm how many locations that will affect.
PHARMACY LEGAL GROUP TO TARGET PBM FEES — The National Community Pharmacists Association has launched a company to pursue arbitration and litigation against pharmacy benefit managers it claims have assessed "junk" direct and indirect remuneration, or DIR, fees on pharmacists.
The company, called TRUST, will investigate claims from individual pharmacies, which NCPA said typically don't have the resources to take PBMs to court.
"The way the contracts are set up, arbitration for claims like these can top $1 million for a single pharmacy," NCPA CEO B. Douglas Hoey said in a statement. "It's still not an even playing field, but we have a much better chance of getting justice if we join forces."
A CMS rule going into effect in January ends the payers' ability to claw back DIR fees after a Medicare Part D drug has been sold, instead requiring they be collected at the time of sale.
"In Medicare, pharmacy DIR programs reduce out-of-pocket costs and improve patient health outcomes," said Greg Lopes, a spokesperson for the PBMs' lobbying group, the Pharmaceutical Care Management Association. "In the commercial market, the programs protect health plans and patients from drug price variation."
A message from 340B Health:
COMPANIES GET $500M FOR VACCINE, THERAPY DEVELOPMENT — The HHS and the White House announced Project NextGen has given more than $500 million to companies developing next-generation vaccines and therapies.
"The technologies that [the Biomedical Advanced Research and Development Authority] is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against Covid-19 for years to come," Dawn O'Connell, assistant secretary for Preparedness and Response, said in a statement.
Funds will be spent on vaccines that may have stronger, broader or longer-lasting response, technologies to speed monoclonal antibody development, more efficient virus testing, genomic sequencing and more.
Eye on the FDAFDA UPDATES NEONATAL MACHINES — Newly manufactured neonatal incubators made by GE HealthCare received after Sept. 5 do not need to be run for a week before they are used because the company "implemented a process to reduce the levels of formaldehyde from new neonatal incubators before distribution," according to the FDA.
GE HealthCare hasn't received reports of patient injury tied to potential formaldehyde exposure in incubators.
"At the present time there is not evidence that the levels of formaldehyde observed in GE HealthCare incubators have led to adverse health effects," the FDA wrote in an updated letter to health care providers.
Pharma MovesCliff Douglas has been named president and CEO of the Foundation for a Smoke-Free World, an organization created by the tobacco giant Philip Morris International to reduce tobacco deaths, though the company is no longer affiliated with the group. Douglas formerly served as director of the University of Michigan Tobacco Research Network.
WHAT WE'RE READINGThe FDA is working on rules that could ban certain hair-straightening products due to health risks, Gray news staff for Arizona's Family.
The FDA indicated it would require Aldeyra Therapeutics to conduct an additional clinical trial before approving the company's dry-eye treatment candidate, Nicole DeFeudis reports for Endpoints News.
Document DrawerThe FDA published draft guidance for drugmakers developing drugs to treat diabetic foot infections.
The FDA issued immediate-in-effect guidance alerting pharmaceutical companies and pharmacists that the agency is concerned that drugs containing ethanol or pharmaceutical alcohol could be vulnerable to methanol contamination.
A message from 340B Health:
340B hospitals are the backbone of the nation's health care safety net, providing essential services to patients with low incomes and those living in rural America. 340B hospitals provide most of the nation's unpaid and Medicaid hospital care, and 340B savings allow them to continue their commitment to mission. 340B savings enable hospitals to stay open, maintaining access to care for the patients and communities they serve. 340B lowers health care costs, and enables doctors, nurses, and pharmacists to provide expanded care for the benefit of their community– all at no cost to the taxpayer. Protecting 340B is the best way to advance the health of patients and communities without burdening taxpayers. Learn more.
Comments
Post a Comment