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Dive Brief:
So far, the FDA has been following a model akin to its practice for influenza vaccines, convening experts in the spring and summer to discuss the best strain for manufacturers to design their shots against.
Initially, the agency favored redesigning COVID vaccines to match the JN.1 variant broadly. It later specified that developers should focus on KP.2 specifically, if possible. The KP.2-targeting shots are expected to produce immune responses that also provide protective benefits against other strains within the JN.1 lineage.
The FDAs approval comes just ahead of the fall and winter seasons, when COVID cases and hospitalizations are expected to climb.
Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants, said Peter Marks, head of the FDA office that reviews vaccines, in a statement.
Pfizer and partner BioNTech said shipping of their reformulated vaccine will begin immediately and that doses will be available in the coming days.Moderna said its shot will be available in pharmacies and clinics in the same time frame.
The companies are using similar processes to manufacture their updated vaccines as they did with prior versions. Their approvals were based on the FDAs review of manufacturing data and nonclinical study results designed to show the shots are effective and safe. Side effects, such as injection site pain and headaches, are anticipated to be like previous boosters.
These updated vaccines meet the agencys rigorous, scientific standards for safety, effectiveness, and manufacturing quality, Marks said.
Novavax has also developed an updated version of its COVID vaccine which, unlike Pfizers and Modernas mRNA shots, is protein-based. The company has also submitted an application for authorization to the agency.
In June, the Centers for Disease Control and Prevention recommended that everyone aged 6 months and older receive an updated COVID vaccine when they are available.
While COVID vaccine uptake could rise this fall, both Pfizer and Moderna have in recent quarters reported steadily declining revenues from their vaccines. As a results, investors have turned their attention toward combination shots the companies are developing, as well as vaccines for respiratory syncytial virus.
Meghan Rosen is a staff writer who reports on the life sciences for Science News. She earned a Ph.D. in biochemistry and molecular biology with an emphasis in biotechnology from the University of California, Davis, and later graduated from the science communication program at UC Santa Cruz.
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A new, highly contagious and severe strain of mpox virus, formerly known as monkeypox, is spreading across the globe following a major outbreak in Africa.
Clade Ib, the new variant of clade I, first reported in September last year among sex workers in the mining town of Kamituga in the Democratic Republic of Congo, has now mutated, affecting children under the age of 15.
On August 14, the World Health Organization and African Center for Disease Control and Prevention (African CDC) declared mpox a global public health emergency for the second time in two years after it spread to DRC neighboring countries that had no previous record of mpox cases.
Responding to the WHO mpox global emergency declaration, Eric Amunga, commonly known as AMERIX on X, accused the WHO of being a criminal organization and asked his 1.9 million followers to shun the safety guidelines it issued:
MONKEYPOX is a scam. Don't comply. Refuse. Pfizer wants to clear its COVID-19 vaccine stocks after people shunned them. Afrika's corrupt political establishment wants to divert the boiling GenZ rebellion. Mpox is another scam by WHO crook.
That is false.
Mpox killed 517 and infected 17,000 this year alone, the African CDC reported. With new, more aggressive mutations, it has elevated to a global health crisis. COVID-19 vaccines do not apply to mpox prevention. A smallpox Jynneos vaccine, developed by the Danish company Bavarian Nordic, is used to treat the mpox virus.
The African Union (AU) Champion on Pandemic Prevention, Preparedness, and Response (PPPR), which represents the 54 African countries, said on August 16 that the number of affected African countries could rise from 13 to 16 after 3 more countries reported cases under investigation for confirmation.
Sweden reported its first case of mpox after the WHO announcement. Since then, new cases have been recorded elsewhere outside of Africa.
Since 2022, the U.S. has recorded 32,000 cases of infections and 58 deaths, mostly affecting gay and bisexual men.
Amunga did not tell his close to 2 million followers on X that mpox is not a new disease. The virus was discovered in 1958 in a colony of monkeys, and the first case of human infection was recorded in 1970 in the Democratic Republic of Congo.
According to the CDC, the virus is most common in the tropical rainforests of West and Central Africa, and thousands of cases are reported every year.
While thoroughly false, Amungas call of no compliance with the WHO mpox recommendations and his portrayal of the vaccine to prevent a severe reaction to the virus as a scam are part of a viral global trend on X, involving thousands of anti-vaxxers and reaching millions of users.
IOWA CITY, Iowa Health leaders in Iowa warn that COVID-19 cases are on the rise across the state, mirroring a national trend.
Iowa Public Health no longer provides specific numbers of cases and hospitalizations. However, wastewater data and the rate of positive tests confirm that new variants are spreading rapidly.
What most folks have noticed over the past couple of weeks or month is a spike in cases once again, Sam Jarvis, with Johnson County Public Health, said.
Although many have returned to living without any precautions, the pandemic continues. While the flu is largely seasonal, spikes in COVID still happen year-round and cases continue to spread around the globe. Years of exposure and vaccination are having a positive impact.
Jarvis said 90% of the U.S. population have some level of immunity, whether from vaccination or infection.
But as time goes on, we'll continue to encourage folks to stay up to date as possible to hopefully reduce symptoms and protect them from getting infected, he said.
Public health officials are concerned as children return to school soon which could potentially increase transmission. However, not everyone is planning to get vaccinated.
Sophia Knauff, a University of Iowa freshman, expressed her doubts.
I don't think there was a lot of research done on it, she said.
Knauff, who plans to get a flu shot, has never received the COVID vaccine and doesn't plan on getting it this year.
I feel like young people like us don't really need that. But, I think definitely the people that are at risk should take all the precautions for sure," she said.
Health leaders said opinions expressing opposition to the vaccine is common.
As the effects of the pandemic fade into the background, the vaccination rate has fallen from the highs seen in 2021.
I believe it's roughly reported between the high 20% to low 40% across the board, but we'd like to see that higher, Jarvis said.
One reason for that is that new variants can evade immunity earned through infection or prior vaccination.
The Centers for Disease Control and Prevention (CDC) could approve new vaccines to protect against the latest variants as early as this week.
Manufacturers said once that happens, they can have the new shots available to the public in a matter of days.
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As the World Health Organization warns about a worrying comeback of COVID-19 amid a summer surge of infections, new vaccines may soon come to Canada this fall.
Health Canada told Global News it is reviewing submissions from Pfizer, Moderna and Novavax for their updated COVID-19 shots targeting the most recent strains circulating and will approve them if they are deemed safe and effective.
Health Canada will authorize the vaccines if, following a thorough and independent scientific review of the evidence, we determine that the vaccines meet safety, quality, and efficacy standards, Nicholas Janveau, a spokesperson for the agency, said in an email Tuesday.
Starting in the fall of 2024, the National Advisory Committee on Immunization (NACI) strongly recommends the most recently updated COVID-19 vaccines for previously vaccinated and unvaccinated individuals at increased risk of SARS-CoV-2infection or severe COVID-19 illness.
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These include everyone aged 65 or older, long-term care home residents, pregnant people, those with underlying medical conditions and people from Indigenous communities.
Receiving the most recently updated COVID-19 vaccine is expected to provide a better immune response against circulating COVID-19 strains compared to earlier vaccines and is especially important for those at increased risk for COVID-19 infection or severe COVID-19 illness, Janveau said.
0:42 COVID-19 rise in cases not surprising, says epidemiologist
The latest Canadian wastewater data, as of Tuesday, shows a moderate viral activity level of COVID-19 in the country, but that could change in the coming months as schools reopen and the weather gets cooler, experts say.
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I think from what weve seen, we are expecting theres going to be a significant amount of COVID in the fall and winter, Allison McGeer, an infectious disease physician at Sinai Health in Toronto, said in an interview with Global News.
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McGeer said since COVID is still a concern in Canada, people should get vaccinated.
Theres still very clearly a benefit to getting your shot when theyre available in Canada to protect you through the winter, she said.
Since the start of the COVID-19 pandemic, the virus has constantly changed and mutated into different variants, keeping vaccine makers on their toes to update their shots.
The KP.3 variant is dominating in Canada right now, accounting for the majority of the COVID-19 cases in the country.
KP.3 is the genetic cousin of KP.1 and KP.2, which are playfully dubbed the FLiRT variants.
These originate fromJN.1, the Omicron subvariant thatfuelled the winter surge.
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2:27 Ontario halts wastewater testing for COVID, other viruses
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Pfizer and Modernas updated mRNA vaccines that are seeking Health Canada approval both target the KP.2 variant.
The pharmaceutical companies told Global News that this variant was selected and prioritized in consultation with the Public Health Agency of Canada.
The introduction of a KP.2-adapted vaccine is expected to provide improved immunity and help protect against the strains that are believed likely to be circulating in the fall, said Sophie Morin, a Pfizer Canada spokesperson.
Moderna said choosing KP.2 for its updated shots aligns with the FDAs recommendation, ensuring a unified approach in North America to best address the dominant strains in this region.
As COVID-19 continues to mutate, these updates help ensure that vaccines provide the best possible effectiveness during the peak respiratory season, Shehzad Iqbal, Moderna Canadas country medical director, told Global News.
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Novavaxs protein-based formula vaccine is also seeking Health Canada approval.
That vaccine targets the JN.1 variant, but is active against KP.2 and KP.3, in addition to other JN.1 sublineage strains, Novavax president and CEO John C. Jacobs said in a July statement.
4:22 Vaccine mandate dropped for health care workers
McGeer said the predominant KP.3 variant circulating across North America is pretty well covered by these new vaccines.
You get some coverage from the old vaccine but theres no doubt that the new vaccines are better adapted to it, she said.
McGeer said its likely that Health Canada will approve the updated vaccines within the next few weeks.
She said for most people it is a good idea to wait for the new shots, but others who are at a greater risk or are travelling might want to talk to their doctors about getting vaccinated earlier.
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Pending approval, Canada has secured a sufficient supply of COVID-19 vaccines to meet provincial and territorial requirements for the fall and winter, Janveau said.
with files from Global News Katie Dangerfield.
2024 Global News, a division of Corus Entertainment Inc.
