For 60 years, doctors and scientists searched for a vaccine against a common virus that, while sometimes deadly, is little known to the public. The hunt is over.
The U.S Food and Drug Administration cleared GSK Plc’s shot against respiratory syncytial virus on Wednesday. The product will go on sale in the coming weeks for older adults.
Medical breakthroughs rarely come alone, and this one is no exception. GSK, seeking to reassert its role as a key vaccine industry player after falling behind in COVID-19, will likely be forced to battle it out with one of the biggest pandemic winners, Pfizer Inc., within weeks.
“This is certainly a revolution in preventative care,” said Emily Field, head of European pharmaceutical research at Barclays Plc. GSK already sells a blockbuster vaccine to protect older adults from shingles, and if they can repeat that success in RSV, “then they’ll be in a very good position,” Field said.
Being first to market will allow GSK to get a head start on discussing its shot with doctors and insurers. AstraZeneca Plc and Sanofi are also preparing a long-acting antibody for RSV this year. And another pandemic hero, Moderna Inc., is working on a messenger RNA shot for the respiratory disease.
RSV proved “one of the more elusive vaccine targets,” Luke Miels, GSK’s chief commercial officer, said in an interview. “The world is fortunate that a number of innovations have enabled this.”
GSK called its shot Arexvy so it would sound like RSV.
Discovered in 1956, the virus quickly became recognized as one of the most common causes of childhood illness. In the 1960s, an experimental vaccine was tested in babies. But instead of protecting the infants, the shot turned out to exacerbate the disease, resulting in more hospitalizations and two deaths.
Chilling effect
The outcome had a chilling effect on the scientific community, damping research efforts for at least another decade.
RSV, characterized by an acute respiratory illness, affects an estimated 64 million people globally and causes 160,000 deaths each year, according to the U.S. National Institute of Allergy and Infectious Diseases.
The virus causes mild respiratory symptoms in healthy adults and older children. Yet for the elderly and babies, it can trigger severe infection and become life-threatening. It’s the leading cause of hospitalization for young kids in America. For severely ill patients, the only option is an approach reminiscent of the pandemic’s early days: to place them on a ventilator to help them breathe.
With four products likely reaching pharmacy shelves in the U.S. this year, drugmakers will be racing to quickly establish dominance. Two markets are emerging: people who are older or have weak immunity and pregnant women and babies.
Young and old
GSK has estimated peak sales at more then £3 billion ($3.7 billion) for its vaccine for adults 60 and above, and analysts see a potential market worth $10 billion by 2032. One of the two vaccines Pfizer plans to introduce targets the same group, as does Moderna’s experimental product.
A U.S. Centers for Disease Control and Prevention panel will meet next month to discuss both GSK and Pfizer’s shots and make recommendations, which could be key to how they’re marketed. Both vaccines have shown high efficacy in clinical trials—roughly 94% against severe disease for GSK and about 86% for Pfizer—and both can be given alongside annual influenza shots.
“This is meaningful innovation,” GSK’s Miels said. “We plan to do it justice.”
One potentially distinguishing factor could be durability. Both companies are expected to soon present data showing whether protection extended over two seasons, which normally occur during colder winter months, similar to flu.
Pfizer has another vaccine in the works that targets pregnant women, extending protection to their babies for about six months months thanks to antibodies transferred from the mother. Astra and Sanofi, meantime, will offer a passive immunization aimed at children through their first RSV season. It will be called Beyfortus, a name chosen to sound like baby fortress.
Long road
“The world’s waited for something like this for 60 years,” said Tonya Villafana, global head of infectious diseases at Astra, who has shepherded the product’s development. She hailed the impact “it could have on babies, their families and health-care systems over the next decade.”
After the 1960s research scare, scientists didn’t really advance on RSV until the late 1970s. That’s when Pfizer’s Bill Gruber, then a medical student, recalls working with a team led by a doctor named Paul Glezen on a new approach.
Glezen wondered why some babies who got RSV developed bronchiolitis and others didn’t, prompting him to study the amount of antibodies passed by their mothers via the umbilical cord.
Gruber, a student and then a resident at Baylor College of Medicine, was in charge of tracking babies showing up at the hospital with bronchiolitis so that Glezen could match them to the cord blood and its antibody content. The idea was to duplicate the levels of maternal antibodies that reduced infection.
Reaching meaningful progress took many more years, in part because of the multiple mechanisms RSV uses to evade immunity. The breakthrough came about a decade ago with a better understanding of the structure of the preF protein that the RSV virus uses to attack human cells.
But when Pfizer showed its maternal shot worked to protect babies after birth last year, Gruber, who is the company’s head of vaccines, knew there was one person he had to share the good news with. On a video call with Glezen, Gruber thanked his 92-year-old former mentor for his years of research, which helped make a sometimes fatal illness a less-threatening prospect for future generations.
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First RSV vaccine caps 60-year search to stem pervasive lung illness (2023, May 6)
retrieved 6 May 2023
from https://medicalxpress.com/news/2023-05-rsv-vaccine-caps-year-stem.html
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.
