The vaccine, called Arexvy from pharmaceutical giant GSK, is approved for adults aged 60 and over. The Centers for Disease Control and Prevention will need to recommend the vaccine before it will be available for use. The agency’s advisory committee for immunizations is next scheduled to meet June 21 to 22 and could discuss the vaccine then.
RSV is a common, highly contagious seasonal respiratory infection. It’s often associated with infants, who are at especially high risk of developing severe disease. In fact, bronchitis from RSV infections is the leading cause of hospitalization among infants under the age of 1 in the US. But the virus is also dangerous for older adults, causing an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths in older adults each year in the country.
In an ongoing, randomized, placebo-controlled clinical study of adults aged 60 and older—in which about 12,500 participants received Arexvy, and 12,500 participants received a placebo— the vaccine reduced the risk of developing lower-respiratory tract infection from RSV by 82.6 percent, and reduced the risk of developing a severe RSV infection by 94.1 percent, the FDA noted.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. The approval Wednesday of this first RSV vaccine is “an important public health achievement to prevent a disease which can be life-threatening,” he added.
Triumph after tragedy
GSK also celebrated the landmark approval, with GSK’s Chief Scientific Officer Tony Wood saying the approval “marks a turning point in our effort to reduce the significant burden of RSV.”
Pfizer also has a vaccine to protect infants that is nearing a regulatory decision. When given to pregnant participants in a phase III trial, the vaccine was 82 percent effective at preventing severe RSV in the infant’s first three months and 69 percent effective over the first six months.
The vaccines are a triumph after researchers spent decades working to find a safe and effective design for the immunizations. Small trials of early vaccine candidates in the 1960s led to children developing more severe RSV than unvaccinated children. Two vaccinated children died following their infections.
Subsequent research showed that those early, doomed vaccines presented a key protein—the F protein—in the wrong conformation, spurring the immune system to generate impotent antibodies and exaggerated inflammatory responses that made the disease worse. It wasn’t until decades later that researchers at the National Institutes of Health figured out how to lock the F protein into a conformation that would induce an effective immune response, paving the way for the current vaccine designs.
Some Ontario doctors have started offering a free shot that can protect babies from respiratory syncytial virus while Quebec will begin its immunization program next month.
The new shot called Nirsevimab gives babies antibodies that provide passive immunity to RSV, a major cause of serious lower respiratory tract infections for infants and seniors, which can cause bronchiolitis or pneumonia.
Ontario’s ministry of health says the shot is already available at some doctor’s offices in Ontario with the province’s remaining supply set to arrive by the end of the month.
Quebec will begin administering the shots on Nov. 4 to babies born in hospitals and delivery centers.
Parents in Quebec with babies under six months or those who are older but more vulnerable to infection can also book immunization appointments online.
The injection will be available in Nunavut and Yukon this fall and winter, though administration start dates have not yet been announced.
This report by The Canadian Press was first published Oct. 21, 2024.
-With files from Nicole Ireland
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
ISLAMABAD (AP) — Polio cases are rising ahead of a new vaccination campaign in Pakistan, where violence targeting health workers and the police protecting them has hampered years of efforts toward making the country polio-free.
Since January, health officials have confirmed 39 new polio cases in Pakistan, compared to only six last year, said Anwarul Haq of the National Emergency Operation Center for Polio Eradication.
The new nationwide drive starts Oct. 28 with the aim to vaccinate at least 32 million children. “The whole purpose of these campaigns is to achieve the target of making Pakistan a polio-free state,” he said.
Pakistan regularly launches campaigns against polio despite attacks on the workers and police assigned to the inoculation drives. Militants falsely claim the vaccination campaigns are a Western conspiracy to sterilize children.
Most of the new polio cases were reported in the southwestern Balochistan and southern Sindh province, following by Khyber Pakhtunkhwa province and eastern Punjab province.
The locations are worrying authorities since previous cases were from the restive northwest bordering Afghanistan, where the Taliban government in September suddenly stopped a door-to-door vaccination campaign.
Afghanistan and Pakistan are the two countries in which the spread of the potentially fatal, paralyzing disease has never been stopped. Authorities in Pakistan have said that the Taliban’s decision will have major repercussions beyond the Afghan border, as people from both sides frequently travel to each other’s country.
The World Health Organization has confirmed 18 polio cases in Afghanistan this year, all but two in the south of the country. That’s up from six cases in 2023. Afghanistan used a house-to-house vaccination strategy this June for the first time in five years, a tactic that helped to reach the majority of children targeted, according to WHO.
Health officials in Pakistan say they want the both sides to conduct anti-polio drives simultaneously.
WASHINGTON (AP) — Millions of people with private health insurance would be able to pick up over-the-counter methods like condoms, the “morning after” pill and birth control pills for free under a new rule the White House proposed on Monday.
Right now, health insurers must cover the cost of prescribed contraception, including prescription birth control or even condoms that doctors have issued a prescription for. But the new rule would expand that coverage, allowing millions of people on private health insurance to pick up free condoms, birth control pills, or “morning after” pills from local storefronts without a prescription.
The proposal comes days before Election Day, as Vice President Kamala Harris affixes her presidential campaign to a promise of expanding women’s health care access in the wake of the U.S. Supreme Court’s decision to undo nationwide abortion rights two years ago. Harris has sought to craft a distinct contrast from her Republican challenger, Donald Trump, who appointed some of the judges who issued that ruling.
“The proposed rule we announce today would expand access to birth control at no additional cost for millions of consumers,” Health and Human Services Secretary Xavier Becerra said in a statement. “Bottom line: women should have control over their personal health care decisions. And issuers and providers have an obligation to comply with the law.”
The emergency contraceptives that people on private insurance would be able to access without costs include levonorgestrel, a pill that needs to be taken immediately after sex to prevent pregnancy and is more commonly known by the brand name “Plan B.”
Without a doctor’s prescription, women may pay as much as $50 for a pack of the pills. And women who delay buying the medication in order to get a doctor’s prescription could jeopardize the pill’s effectiveness, since it is most likely to prevent a pregnancy within 72 hours after sex.
If implemented, the new rule would also require insurers to fully bear the cost of the once-a-day Opill, a new over-the-counter birth control pill that the U.S. Food and Drug Administration approved last year. A one-month supply of the pills costs $20.
Federal mandates for private health insurance to cover contraceptive care were first introduced with the Affordable Care Act, which required plans to pick up the cost of FDA-approved birth control that had been prescribed by a doctor as a preventative service.
The proposed rule would not impact those on Medicaid, the insurance program for the poorest Americans. States are largely left to design their own rules around Medicaid coverage for contraception, and few cover over-the-counter methods like Plan B or condoms.
