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Health Canada approves Moderna’s bivalent COVID-19 booster for BA.4, BA.5 subvariants

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Health Canada has authorized another Moderna bivalent COVID-19 booster vaccine for those 18 years and older to tackle the Omicron BA.4 and BA.5 subvariants of COVID-19, two months after the company’s first bivalent booster was approved.

Moderna’s first bivalent shot for the BA.1 subvariant was approved in early September, while Pfizer’s BA.4, BA.5 bivalent COVID-19 vaccine — that company’s first bivalent booster — was given the go-ahead earlier in October. BA.4 and BA.5 are the dominant strains circulating now in Canada, according to the health agency.

Health Canada deemed Moderna’s latest “Spikevax” booster “safe and effective” after a “thorough and independent scientific review of the evidence.”

“Clinical trial results showed that a booster dose of the bivalent Moderna Spikevax vaccine triggers a strong immune response against both Omicron (BA.4/BA.5) and the original SARS-CoV-2 virus strains,” Health Canada said in a statement Thursday.

“This adapted vaccine has a similar safety profile to the previously approved Moderna Spikevax boosters, with the same mild adverse reactions that resolved quickly.”

Health Canada said it and the Public Health Agency of Canada will closely monitor the vaccine’s safety and promises to take action if any concerns are identified.

According to the National Advisory Committee on Immunization (NACI), there is currently no evidence to suggest that there is any meaningful difference in protection between the bivalent boosters targetting the BA.1 versus the BA.4/5 subvariants. There is also no clinical trial directly comparing the Moderna (50 mcg) and Pfizer-BioNTech (30 mcg) bivalent boosters.

For those who got Moderna’s first bivalent booster, Health Canada said in September that clinical data shows that the booster still generates “a good immune response against the Omicron BA.4 and BA.5 subvariants, and is expected to extend the durability of protection.”

NACI recommends that fall COVID-19 booster doses be offered six months after a previous COVID-19 vaccine or infection of the virus. A shorter interval of three months may be considered, especially for those with heightened epidemiological risks, but it is not expected that a booster dose will be routinely provided every three months, according to NACI.

Moderna is projecting US$4.5 billion to US$5.5 billion in sales from COVID-19 vaccine contracts in 2023, down from analysts’ estimates of US$9.5 billion as demand has dropped and production has been stalled due to quality control issues at its contract manufacturing partner.

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Some Ontario docs now offering RSV shot to infants with Quebec rollout set for Nov.

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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.

The Canadian Press. All rights reserved.

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Polio is rising in Pakistan ahead of a new vaccination campaign

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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.

The Canadian Press. All rights reserved.

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White House says health insurance needs to fully cover condoms, other over-the-counter birth control

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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.

The Canadian Press. All rights reserved.

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