The U.S. Department of Health and Human Services (HHS) is awarding the pharmaceutical company Moderna $590 million to continue developing a vaccine to protect against bird flu.

This funding, announced Friday by Moderna, builds on the $176 million it received from HHS last year to support earlier stages of vaccine research.

Moderna’s vaccine is designed to target H5 and H7 avian influenza viruses.

The company plans to move into phase 3 clinical trials to test the vaccine in a larger group of people after receiving positive results in earlier phases. It said those findings will be shared at an upcoming scientific conference.

“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past," outgoing HHS secretary Xavier Becerra said in a statement, who added that the response had been a top priority for HHS and the Biden administration.

“Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe,” he continued.

Avian influenza, commonly known as bird flu, refers to several types of influenza that typically infect birds. But certain variants, such as H5N1, have raised alarm among health officials because they can occasionally infect humans.

Over the past several months, dozens of people in the U.S. have been sickened by the virus, including the first reported human death from bird flu in Louisiana earlier this month.

While the U.S. already has vaccines against H5 viruses in its Strategic National Stockpile, they are based on older technology. Moderna’s new mRNA-based vaccine aims to offer a more effective option.

"The project will provide additional support for late-stage development and licensure of pre-pandemic mRNA-based vaccines," Moderna said in a news release. "The agreement will also support the expansion of clinical studies for up to five additional subtypes of pandemic influenza."

Under the Biden administration, HHS also pledged more than $300 million to improve bird flu surveillance, testing, hospital preparedness, and public awareness.

While most recent cases of H5N1 have involved animal-to-animal transmission, federal health officials emphasize the importance of staying vigilant and working together to protect human and animal health.

The U.S. Centers for Disease Control and Prevention considers the current risk of bird flu to the public to be low, as there is still no evidence of human-to-human transmission. But experts warn that it is important to keep investing in monitoring and vaccine development to stay ahead of possible threats.

More information

The U.S. Centers for Disease Control and Prevention (CDC) has more on the current bird flu situation.

SOURCE: U.S. Department of Health and Human Services, news release, Jan. 17, 2025; Moderna, news release, Jan. 17, 2025; CNN

Copyright © 2020 HealthDay. All rights reserved.

Based on data from Southern Hemisphere countries, a low proportion of patients with influenza-associated severe acute respiratory illness (SARI) were vaccinated against influenza, according to research published in the Oct. 3 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Erica E. Zeno, Ph.D., from the CDC in Atlanta, and colleagues conducted interim estimates of influenza vaccine effectiveness (VE) from Southern Hemisphere countries, which can help guide Northern Hemisphere countries in advance of their season. Interim VE against influenza-associated SARI hospitalization was estimated using data from a multicountry network.

The researchers identified 11,751 influenza-associated SARI cases during March 13 to July 19, 2024, in Argentina, Brazil, Chile, Paraguay, and Uruguay. On average, 21.3 percent of these patients were vaccinated against influenza, with an adjusted VE of 34.5 percent against hospitalization. The adjusted VE was 36.5 percent against the predominating subtype A(H3N2) and was 37.1 percent against A(H1N1)pdm09.

"These data suggest that influenza vaccine demand was still low post-COVID-19 but that vaccination prevented approximately one-third of influenza-associated hospitalizations among groups at high risk for influenza-associated complications," the authors write. "These findings support [the U.S. Centers for Disease Control and Prevention and World Health Organization's] recommendation that all eligible persons aged ≥6 months should receive influenza vaccination."

One author disclosed participating on a data safety monitoring board for Moderna's candidate mRNA respiratory syncytial virus vaccine for pregnant women.

Abstract/Full Text

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The free COVID-19 tests promised by the U.S. government are now available.

"U.S. households will be eligible to order four free COVID-19 tests at COVIDTests.gov," according to the U.S. Department of Health and Human Services. "The COVID-19 tests will detect current COVID-19 variants and can be used through the end of the year."

More than 900 million such tests have already been distributed to help people get tested and treated earlier and to perhaps keep them from spreading COVID-19 to others.

"At-home COVID tests can be taken at home or in other locations and typically provide results within 30 minutes or less," according to the HHS. "COVID tests can be administered to both vaccinated and unvaccinated individuals."

Testing may come in handy as gatherings for Halloween, Thanksgiving, and Christmas push people into close proximity.

"The best plan going into this winter is for everyone to remain vigilant, to use the tools we have: vaccines, testing, treatment against the illnesses responsible for the majority of fall and winter deaths and hospitalizations," Mandy Cohen, M.D., director of the U.S. Centers for Disease Control and Prevention, said Friday, CNN reported.

As for vaccines, the latest, strain-specific formulation of COVID-19 vaccine is now available, in both the RNA form (Moderna and Pfizer) or the Novavax protein-based alternative. The mRNA vaccines target the KP.2 "FLiRT" variant, which has been a dominant strain since late spring, while the Novavax shot targets JN.1, which is still around but perhaps less dominant than in months past.

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The U.S. government is offering another round of free COVID-19 tests, which will be available by the end of September.

"U.S. households will be eligible to order four free COVID-19 tests at COVIDTests.gov," according to the U.S. Department of Health and Human Services. "The COVID-19 tests will detect current COVID-19 variants and can be used through the end of the year."

More than 900 million such tests have already been distributed to help people get tested and treated earlier and to perhaps keep them from spreading COVID-19 to others.

"At-home COVID tests can be taken at home or in other locations and typically provide results within 30 minutes or less," according to the HHS. "COVID tests can be administered to both vaccinated and unvaccinated individuals."

Testing may come in handy as gatherings for Halloween, Thanksgiving, and Christmas push people into close proximity.

"The best plan going into this winter is for everyone to remain vigilant, to use the tools we have: vaccines, testing, treatment against the illnesses responsible for the majority of fall and winter deaths and hospitalizations," Mandy Cohen, M.D., director of the U.S. Centers for Disease Control and Prevention, said Friday, CNN reported.

As for vaccines, the latest, strain-specific formulation of COVID-19 vaccine is now available, in both the RNA form (Moderna and Pfizer) or the Novavax protein-based alternative. The mRNA vaccines target the KP.2 "FLiRT" variant, which has been a dominant strain since late spring, while the Novavax shot targets JN.1, which is still around but perhaps less dominant than in months past.

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Copyright © 2020 HealthDay. All rights reserved.

As a summer surge in COVID cases begins to ebb and Americans brace themselves for yet another wave of infections this winter, more free COVID tests will soon be available to all, federal health officials announced Friday.

Starting in late September, every U.S. household can order up to four nasal swab tests when the federal program reopens, according to COVIDtests.gov.

The U.S. Health and Human Services (HHS) agency that oversees the testing has not yet announced an exact date for ordering to begin. Since the pandemic began, the program has distributed over 900 million tests directly to American households, the notice said.

"COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others," the HHS announcement said.

The tests will detect the virus strains that are now circulating and can be ordered ahead of the holiday season when family and friends gather indoors, an HHS spokesperson told CBS News.

The news comes right on the heels of the U.S. Food and Drug Administration's approval of updated mRNA COVID vaccines from Pfizer and Moderna for the fall season. Novavax is expected to get approval for its updated vaccine sometime this year.

The U.S. Centers for Disease Control and Prevention recommends all Americans ages 6 months and older get a shot of the "updated 2024-2025 COVID-19 vaccine."

While most Americans have some immunity to COVID from prior infections or vaccinations, government data show less than a quarter of U.S. adults signed up for last fall's COVID shots, CBS News reported.

Although deaths and serious infections have dropped dramatically since the pandemic began in 2020, hospitalizations have started to edge up in recent weeks, CDC data show. In total, more than 1 million Americans have died from the virus.

More information

The CDC has more on COVID-19.

SOURCE: U.S. Department of Human Health and Services, update, Aug. 23, 2024; CBS News

Copyright © 2020 HealthDay. All rights reserved.

Updated shots to shield against COVID-19 infection were approved by the U.S. Food and Drug Administration on Thursday.

This year's approval for the updated mRNA vaccines comes much sooner than happened in 2023, when fall vaccines were authorized on Sept. 11.

The latest shots from Moderna and Pfizer will now target a variant of the Omicron strain of the virus called KP.2, the FDA said in a statement.

"The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death," the FDA said.

The agency had already told Moderna and Pfizer in June that the JN.1 lineage of SARS-Cov-2 should be the autumn shots' target, and then more specifically the KP.2 strain.

According to data from the Centers for Disease Control and Prevention, the prevalent COVID variant is now KP.3.1.1, thought to make up 37% of cases over the past two weeks.

KP.3.1.1 and KP.2, which are covered by the updated shots, are offshoots of JN.1. All are members of the Omicron family.

"Vaccination continues to be the cornerstone of COVID-19 prevention," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in the statement.

"These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness and manufacturing quality," he added. "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."

The Moderna and Pfizer vaccines are currently recommended for use by everyone aged 6 months and older. The guidelines for use by vaccination status or age are:

• Unvaccinated small children: Between 6 months and 4 years of age, this group should receive three doses of the updated Pfizer vaccine or two doses of the updated Moderna vaccine.

• Previously vaccinated small children: One or two doses of either vaccine, depending on the previous COVID vaccine the child received.

• Children ages 5 through 11: Regardless of prior vaccination status, a single dose of either the updated Moderna or Pfizer vaccine should be given. If previously vaccinated, the new dose should be given at least two months after the last shot.

• People ages 12 and older: A single dose of the newly updated and approved Moderna or Pfizer vaccines. If previously vaccinated, the new dose should be given at least two months after the last shot.

• Immunocompromised individuals: Additional doses are authorized for children between the ages of 6 and 11, as described in fact sheets accompanying the vaccines.

"Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines," the FDA said.

The agency added that, "the updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants," and the new shots are manufactured using the same processes as prior vaccines.

"The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks," the FDA stressed.

Thursday's approval comes as Americans are suffering through a summer surge of COVID cases -- the highest seen since the summer of 2022, based on wastewater levels of virus tracked by the U.S. Centers for Disease Control and Prevention.

Still, experts note that although levels of severe disease have been rising, they remain much lower than those seen during the early years of the pandemic.

Both Moderna and Pfizer have said they have ample supplies of their updated COVID vaccines on hand, ready for shipment to stores soon after FDA approval. If approved, the Novavax vaccine may take a bit longer to reach consumers, because its protein-based shot takes more time to manufacture than mRNA vaccines do.

In June, the CDC recommended that every American over the age of 6 months receive an updated COVID-19 shot along with the flu shot this year.

More information

Find out more about the COVID vaccine at the Mayo Clinic.

SOURCE: U.S. Food and Drug Administration, news release, Aug. 22, 2024

Copyright © 2020 HealthDay. All rights reserved. 

Updated COVID-19 vaccines may receive approval from the U.S. Food and Drug Administration this week.

Two sources familiar with the issue told CNN that updated mRNA vaccines from Moderna and Pfizer that target the KP.2 variant could be greenlit as early as this week. The news agency said the sources declined to be named because information around the timing of approval has not yet been made public. It is not clear whether approval for the Novavax non-mRNA shot, targeted to the JN.1 strain, would be approved simultaneously.

If approval does come this week, that would be a few weeks ahead of the timing for last fall's shots, which were approved on Sept. 11.

The news comes as Americans are suffering through a summer surge of COVID-19 cases -- the highest seen since the summer of 2022, based on wastewater levels of virus tracked by the U.S. Centers for Disease Control and Prevention.

According to CDC data, the prevalent COVID-19 variant is now KP.3.1.1, thought to make up 37 percent of cases over the past two weeks. Still, experts note that although levels of severe disease have been rising, they remain much lower than those seen during the early years of the pandemic. KP.3.1.1 and KP.2, which are both covered in the updated shots, are offshoots of JN.1. All are members of the omicron family.

Both Moderna and Pfizer have said they have ample supplies of their updated COVID-19 vaccines on hand, ready for shipment to stores soon after FDA approval. The Novavax vaccine may take a bit longer to reach consumers, because its protein-based shot takes longer to manufacture than mRNA vaccines do.

In June, the CDC recommended that every American older than 6 months of age receive an updated COVID-19 shot along with the flu shot this year.

CNN Article

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U.S. health officials announced Tuesday that the federal government will pay Moderna $176 million to speed development of a pandemic flu vaccine based on mRNA technology.

Such a vaccine could be used to treat bird flu in people, as concern grows about H5N1 cases spreading in dairy cows across the country, the U.S. Department of Health and Human Services (HHS) noted.

“We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises. As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities,” HHS Secretary Xavier Becerra said in a news release announcing the investment. “The Biden-Harris Administration won’t stop until we have everything we need to prepare for pandemics and other public health emergencies that impact the American public.”

Moderna already has a bird flu vaccine in early-stage testing that uses the same mRNA technology that allowed a rapid rollout of COVID vaccines, the Associated Press reported.

Some of the new HHS funds will go toward a late-stage trial next year if early results with Moderna's mRNA-based flu vaccine are positive.

“The award made today is part of our longstanding commitment to strengthen our preparedness for pandemic influenza,” Dawn O’Connell, assistant secretary for preparedness and response, said in the HHS news release. “Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants.”

The vaccine development could also quickly target another form of influenza if a threat other than the H5N1 form of bird flu emerges, HHS officials stressed.

The award was made through the Biomedical Advanced Research and Development Authority (BARDA), a program that focuses on medical treatments for potential pandemics.

The H5N1 virus was detected earlier this year in dairy cows and has spread to more than 135 herds in 12 states and has infected three people to date, all with mild cases.

In a bit of good news about bird flu, the U.S. Food and Drug Administration released results of a preliminary study last week that found flash pasteurization kills virtually all bird flu virus in milk.

More information

The U.S. Centers for Disease Control and Prevention has more on flu vaccines.

SOURCES: U.S. Department of Health and Human Services, news release, July 2, 2024; Associated Press

Copyright © 2020 HealthDay. All rights reserved. 

As a summer wave of COVID infections rolls across the country, U.S. health officials have recommended that all Americans over the age of 6 months get one of the updated COVID vaccines when they become available this fall.

The recommendation was issued Thursday by the U.S. Centers of Disease Control and Prevention after its vaccine advisory panel weighed in on who should get the shots. The panel made the same recommendation for flu vaccinations this fall, with rare exceptions.

“Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated,” CDC Director Dr. Mandy Cohen said in a statement. “Make a plan now for you and your family to get both updated flu and COVID vaccines this fall, ahead of the respiratory virus season.”

By now, nearly all Americans have had a COVID infection, gotten a COVID vaccine or both, but the updated vaccines offer a timely boost as immunity wanes and the virus continues to evolve, the CDC said.

“Professionals and the public in general do not understand how much this virus has mutated,” said Carol Hayes, the CDC vaccine advisory committee’s liaison to the American College of Nurse-Midwives, the New York Times reported.

“COVID is still out there, and I don’t think it’s ever going away,” Dr. Steven Furr, president of the American Academy of Family Physicians, told the Times.

For Americans who decide to get the latest COVID shots, there will be a choice among this year's vaccines: The Novavax shot will target JN.1, the variant that prevailed during the winter, while the Pfizer and Moderna shots will take aim at KP.2, which until recently seemed poised to become the dominant variant.

But two related variants, KP.3 and LB.1, now account for more than half of new cases. All three variants are descendants of JN.1.

While mutations are thought to help the variants evade immune defenses and spread faster, there is no evidence they cause more severe illness, the CDC has said.

The biggest risk factor for severe illness is age. Americans 65 and older account for two-thirds of COVID hospitalizations and 82 percent of in-hospital deaths, according to the CDC. Yet, only about 40 percent of Americans in that age group were immunized with the COVID vaccines that were offered last fall, the Times reported.

“This is an area where there’s a lot of room for improvement and could prevent a lot of hospitalizations,” said Dr. Fiona Havers, a CDC researcher who presented the hospitalization data, the Times reported.

Children -- particularly those under the age of 5 -- are also vulnerable, but only about 14 percent got COVID vaccines last fall, the Times reported.

Even if children do not fall ill themselves, they can fuel circulation of the virus, especially once they return to school this fall, Furr said.

“They’re the ones that, if they’re exposed, are more likely to bring it home to their parents and to their grandparents,” he said. “By immunizing all groups, you’re more likely to prevent the spread.”

It is also “critical that pregnant persons get vaccinated, not only to protect themselves but also to protect their infants until they are old enough to be vaccinated,” panelist Dr. Denise Jamieson, dean of the Carver College of Medicine at the University of Iowa, told the Times.

During the advisory panel meeting, CDC researchers did say they have detected that Pfizer’s COVID vaccine may trigger four more cases per 1 million shots of a rare neurological condition known as Guillain-Barré syndrome.

More information

The CDC has more on COVID vaccines.

SOURCE: U.S. Centers for Disease Control and Prevention, news release, June 28, 2024; New York Times

Copyright © 2020 HealthDay. All rights reserved.

In new vaccination guidance issued Wednesday, U.S. health officials now recommend that all Americans aged 75 and older get an RSV vaccine before fall arrives.

However, those a bit younger -- ages 60 to 74 -- should only seek the shot if they are vulnerable to severe RSV because of chronic medical conditions such as lung or heart disease, or if they live in nursing homes, the U.S. Centers for Disease Control and Prevention advised.

The recommendations came from a committee of CDC advisers and the agency has approved that guidance, making the advice official.

"The CDC has updated its RSV vaccination recommendation for older adults to prioritize those at highest risk for serious illness from RSV,” CDC Director Dr. Mandy Cohen said in an agency news release. “People 75 or older, or between 60-74 with certain chronic health conditions or living in a nursing home, should get one dose of the RSV vaccine to provide an extra layer of protection.”

The new guidelines only apply to adults who did not get an RSV vaccine last year, the CDC noted, because people do not need to get a shot every RSV season. The best time to get vaccinated is in late summer and early fall, before RSV starts spreading through the country, the agency added.

Just a year ago, the same CDC advisory panel recommended that people 60 and older simply talk to their doctors about whether to get the shots. Physicians have said the tepid recommendation confused patients and is probably why less than 25% of older Americans have gotten a RSV shot, the Associated Press reported.

RSV (respiratory syncytial virus) is a common cause of cold-like symptoms, but it can be dangerous for infants and the elderly.

Last year, the U.S. Food and Drug Administration licensed two single-dose RSV vaccines, made by GSK and Pfizer, for older people. At the time, the vaccine advisers refrained from saying that all older Americans should get the shots because of questions about possible side effects and the duration of protection, the AP reported.

Some of those questions remain, and on Wednesday panel members said no to a request by vaccine manufacturers to recommend the shots for all Americans aged 60 and older. The panel also declined to endorse giving the GSK vaccine to people in their 50s, even though the FDA this month licensed the company’s shot for that age group, the AP reported.

A newly approved RSV shot from Moderna will be subject to the same guidance.

Panel members said Wednesday that evidence has shown the shots make sense for all people 75 and older, because they are at higher risk for severe RSV. But they drew narrower guidelines for those aged 60 to 74.

Underlying the panel’s hesitancy are reports of a nervous system disorder, Guillain-Barre syndrome. Though rare, there have been a higher-than-expected number of Guillain-Barre cases among RSV vaccine recipients, particularly in those who got the Pfizer shot.

FDA officials noted Wednesday there is no clear evidence the shots are causing the disorder, but some panel members noted research is still ongoing.

“I do agree with the overall conclusion that the risks of RSV vaccination are greatly outweighed by the overall benefits,” said panel member Dr. Camille Kotton, an infectious diseases expert at Massachusetts General Hospital. “Nonetheless, I remain quite concerned” about recurring indicators of Guillain-Barre in vaccination surveillance data, she added.

More information

The CDC has more on RSV.

SOURCE: U.S. Centers for Disease Control and Prevention, news release, June 26, 2024; Associated Press

Copyright © 2020 HealthDay. All rights reserved.

COVID vaccine makers will be advised to update their shots to target the KP.2 variant, an offshoot of the JN.1 variant that spread widely last winter, the U.S. Food and Drug Administration announced Thursday.

It's a turnaround for the agency: The new recommendation follows an FDA advisory panel vote last week that unanimously recommended COVID vaccines target the older JN.1 variant this fall.

Following that vote, panel members and Dr. Peter Marks, the agency’s top vaccine regulator, differed on which variant the agency should choose to target. Most panel members chose JN.1, while Marks preferred selecting a newer strain, such as KP.2.

"We are paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines," Marks said at the time.

Although the FDA said it first advised vaccine makers to target JN.1, the most current data, along with a recent rise in COVID cases, suggests the preferred variant for the updated vaccines to target is now the KP.2 strain, the FDA said.

"[The] FDA has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines," the agency added. "The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines for the United States."

JN.1 has largely fallen out of circulation in the United States, according to the U.S. Centers for Disease Control and Prevention. KP.2 now accounts for 22.5% of new COVID cases in this country while KP.3, a sister variant, is fueling 25% of new cases.

Three drugmakers produce COVID vaccines: Pfizer, Moderna and Novavax. Pfizer's and Moderna's vaccines are mRNA-based, while Novavax's is protein-based. Because protein-based vaccines take much longer to manufacture, Novavax has indicated it won't be able to make a KP.2 vaccine in time for the fall, NBC News reported. Instead, it plans to distribute a JN.1 vaccine, which it had already been producing.

The process of selecting the next round of COVID vaccines is falling into a routine that mimics how the annual flu shot is updated.

During the FDA advisory committee meeting, vaccine makers presented data showing that a JN.1 vaccine should generate higher levels of antibodies against circulating strains of the virus compared to the current vaccine, which targets XBB.1.5, a variant no longer in circulation.

The FDA advisory committee did not recommend who should get the updated shots. That question will be tackled by the CDC, which is holding its own advisory committee meeting on vaccines later this month.

More information

The CDC has more on COVID vaccines.

SOURCE: U.S. Food and Drug Administration, news release, June 13, 2024; NBC News

Copyright © 2020 HealthDay. All rights reserved.

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness.

Drugmaker GSK's Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already approved for use in adults 60 and older, since age brings higher risk from RSV disease.

Arexvy is the first to get the nod for people ages 50 to 59 with certain health risk factors.

"A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old," GSK said in a company statement released Friday.

"Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions," the company added. "RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death."

Experts at the U.S. Centers for Disease Control and Prevention are expected to meet in June and October, at which time they might also sign off on the use of Arexvy in people in their 50s. Doing so would give the green light for insurance coverage.

According to CBS News, Pfizer and Moderna are also testing their RSV vaccines for use in younger patients.

Arexvy's safety profile among people in their 50s appears to be similar to that among older people. Less than 10% of people in their 50s who got the shots had any reaction, GSK said, with the most common being injection site pain, fatigue, muscle ache and headache.

According to CBS News, the CDC's advisory panel has been weighing the risk of a neurological condition, Guillain-Barré syndrome (GBS), seen in very rare cases after RSV vaccination. The CDC pegs the rate of GBS at 1.5 cases per million doses.

GSK's latest trial data failed to reveal any "concerning" trends of GBS cases in the 50-to-59 age group, Dr. Phil Dormitzer, senior vice president and global head of vaccines research and development at GSK, told CBS News.

"The risk of GBS tends to go up, it's another one of those risks that tends to go up, with age. But there's nothing to indicate that there's any particular risk of GBS," he said.

New data will be presented to the CDC this month on spacing RSV booster shots for older adults, Dormitzer said.

"This is a really key question," he said. "People originally anticipated it might have to be an every year immunization. But then we found the duration of protection actually lasts for more than one season, clearly."

Trials looking at the use of Arexvy in 18- to 49-year-olds are expected in the later half of the year, GSK said.

More information

Find out more about RSV in older adults at the CDC.

SOURCES: GSK, news release, June 7, 2024; CBS News

Copyright © 2020 HealthDay. All rights reserved.

An experimental vaccine that could offer one-stop prevention for both COVID-19 and influenza is showing positive results among older adults in trials, maker Moderna announced Monday.

The shot — for now called mRNA-1083 — "has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial," Moderna said in a statement.

The phase 3 trial is only another step towards approval of the dual-purpose shot, which won't be okayed in time for this year's flu season.

However, "combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Moderna CEO Stéphane Bancel said in the statement.

According to the company, the new vaccine contains "components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate."

In a trial involving more than 4,000 adults ages 65 or older, the mRNA-1083 vaccine triggered immune responses to three influenza variants as well as to the SARS-CoV-2 virus (which causes COVID) that equaled those of vaccines already approved against either flu or COVID. The three influenza variants are H1N1, H3N2 and B/Victoria.

Similar results were also seen in another group of about 4,000 people between 50 and 64 years of age, Moderna said.

The trial was "blinded," meaning that neither the patients nor the people conducting the trial knew who got which vaccines.

Moderna added that the new combo vaccine's safety profile appeared similar to that of vaccines targeted to just one virus.

The new findings have not yet been peer-reviewed, although Moderna said it plans to submit the trial results for publication and to possible review by the U.S. Food and Drug Administration (FDA).

The real issue is whether vaccine-fatigued Americans will avail themselves of the dual-purpose vaccine, should it become available, said Sue Peschin, president and CEO of the non-profit Alliance for Aging Research.

Speaking with CNN, she noted the percentage of Americans who get any form of vaccine has dropped.

For example, only a quarter of eligible Americans have gotten the latest COVID-19 vaccine, according to a presentation to the FDA last week. Uptake of the flu shot did rise slightly last year, with the Centers for Disease Control and Prevention reporting that nearly half of adults got one last season.

“We want to see that go up and if there’s a way to do that by combining the vaccines, then that’s better for everyone because it helps protect everyone in the community,” Peschin said. “We would love to see the combination vaccines come to market if the FDA deems them safe and effective.”

More information

Find out more about preventing flu at the Mayo Clinic.

SOURCES: Moderna, news release, June 10, 2024; CNN

Copyright © 2020 HealthDay. All rights reserved.

A U.S. Food and Drug Administration advisory panel on Wednesday recommended updating the formula for COVID vaccines ahead of a fall campaign that will encourage Americans to get the latest shots.

The unanimous vote recommends that vaccine makers tailor the next vaccine to target the JN.1 variant, which dominated infections in the United States last winter, the New York Times reported. However, JN.1 has been overtaken by descendants known as KP.2 and KP.3 this spring.

The FDA is expected to formally recommend a new variant target for vaccine makers in the coming weeks, the Times reported.

Dr. Peter Marks, who oversees the FDA's vaccine division, urged the committee to consider encouraging the mRNA vaccine makers to focus on the latest versions of the virus, and not the JN.1 variant, the Times reported.

“We always say we shouldn’t be chasing strains, but we’re paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines,” he said, referring to the technology used by Moderna and Pfizer.

“If this evolves further in the fall, will we regret not having been a little bit closer?” Marks asked.

But Dr. Sarah Meyer, a senior vaccines official at the U.S. Centers for Disease Control and Prevention, said that aiming at JN.1 was more appropriate because it was “further up on the tree” in the evolution of the coronavirus, possibly allowing the vaccines to better cover future mutations in the virus, the Times reported.

The panel's decision mirrors guidance from a World Health Organization expert committee that recommended in April that COVID vaccines switch to a JN.1 formulation.

Representatives of Moderna and Pfizer said that the companies would be ready to produce either version of the vaccine, the Times reported.

During the meeting, federal health officials reported that COVID cases remain relatively low, with data showing that illnesses from JN.1 were not more severe than those from earlier variants, the Times said.

Less than 400 COVID deaths a week have been recorded recently, down from a peak of roughly 2,500 a week over the winter.

Still, last year’s COVID vaccination rate was markedly low, with CDC researchers reporting that only 18 percent of immunocompromised adults had gotten the updated vaccine, while just over 20 percent of all adults had received the shot.

As for nursing home residents, the most likely to suffer from severe illness, CDC data show that about 30 percent of nursing home residents are up-to-date on their shots, down from 65 percent two years ago.

More information

The CDC has more on COVID vaccines.

SOURCE: New York Times

Copyright © 2020 HealthDay. All rights reserved.

FRIDAY, Feb. 23, 2024 (HealthDay News) -- Amid an outbreak of measles at a Florida elementary school, the state's surgeon general has defied federal health guidance and told parents it's up to them whether they want to keep their unvaccinated child home to avoid infection.

In a letter to parents of children attending Manatee Bay Elementary school in Weston, where six cases of measles have already been reported, Florida surgeon general Dr. Joseph Ladapo said the state health department “is deferring to parents or guardians to make decisions about school attendance.”

That advice runs counter to what Ladapo acknowledged in his letter was the “normal” recommendation that parents keep unvaccinated children home for up to 21 days -- the incubation period for measles.

This is not the first time that Ladapo has challenged health recommendations from the U.S. Centers for Disease Control and Prevention: Last month, he called for halting the use of COVID vaccines made by Pfizer and Moderna.

Ben Hoffman, president of the American Academy of Pediatrics, told the Washington Post that Florida’s new guidance flies in the face of standard public health guidance for measles, a disease that can result in severe complications and even death.

“It runs counter to everything I have ever heard and everything that I have read,” Hoffman said. “It runs counter to our policy. It runs counter to what the [CDC] would recommend.”

As more parents seek exemptions from childhood vaccinations, measles cases have climbed in this country.

In 2024 alone, at least 26 cases in at least 12 states have been reported to the CDC, roughly double the number at this point last year. Along with the six cases confirmed in the Florida school, cases have been reported in Arizona, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania and Virginia.

In January, the CDC issued a warning to health providers to be on alert for more measles cases. Infected people are contagious starting four days before a rash develops and up to four days afterward.

Measles is highly contagious, particularly to unvaccinated people: Up to 90% of those without immunity will contract measles if exposed, the CDC says. Conversely, those who have been infected or received the full two doses of the MMR vaccine are 98% protected. 

“The reason why there is a measles outbreak in Florida schools is because too many parents have not had their children protected by the safe and effective measles vaccine,” John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York City, told the Post. “And why is that? It’s because anti-vaccine sentiment in Florida comes from the top of the public health food chain: Joseph Ladapo.”

When asked to comment, the Florida health department sent a link to Ladapo’s letter, the Post reported.

Paul Offit, a pediatric infectious diseases expert at Children’s Hospital of Philadelphia, told the Post that Ladapo’s failure to urge vaccination or quarantining endangers children.

“Is he trying to prove that measles isn’t a contagious disease when the data are clear that it is the most contagious vaccine-preventable disease, far more contagious than influenza or COVID?” Offit said.

A drop below 95 percent vaccination coverage for measles can jeopardize herd immunity. Florida’s state vaccination coverage is 90.6 percent, the Post reported.

About 1 in 5 unvaccinated Americans who catch the measles is hospitalized, according to the CDC. Up to 1 of 20 children develop pneumonia. Nearly 1 child out of every 1,000 with measles will develop swelling of the brain that can leave a child deaf or with an intellectual disability. For unvaccinated infants who get the measles, 1 in 600 can develop a fatal neurological complication that can lie dormant for years.

More information

The U.S. Centers for Disease Control and Prevention has more on the history of measles.

SOURCE: Florida Surgeon General, parent letter, Feb. 20, 2024; Washington Post

Copyright © 2020 HealthDay. All rights reserved. 

FRIDAY, April 28, 2023 (HealthDay News) -- Travelers to the United States will now only need a single bivalent COVID-19 vaccine from either Pfizer or Moderna to enter the country, the U.S. Centers for Disease Control and Prevention announced Thursday.

The loosening of vaccination requirements for foreign travelers comes as many other countries have already done so.

"Because some traveler vaccine records might not specify whether recent Moderna or Pfizer doses received were bivalent, CDC will consider anybody with record of a single dose of Moderna or Pfizer vaccine issued on or after August 16, 2022, to meet the requirements," because that was when bivalent vaccines first became available, the agency said in an update to its website.

Earlier this month, the CDC and the U.S. Food and Drug Administration changed the vaccine schedule so that unvaccinated Americans could be considered fully vaccinated with just one dose of bivalent vaccine instead of the earlier versions, CBS News reported. Another federal agency, the U.S. Centers for Medicare & Medicaid Services, announced that health care workers would be considered "fully vaccinated" with the one bivalent dose.

Travel industry officials have said they expected the vaccination requirement to be allowed to expire altogether, CBS News reported. At this point, the Transportation Security Administration has renewed the requirement through May 11.

A spokesperson for the Department of Health and Human Services said there was no update on the requirement, CBS News reported.

CBS News Article

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TUESDAY, April 18, 2023 (HealthDay News) -- Seniors and people with weakened immune systems can get another booster dose of the bivalent COVID-19 vaccine this spring, the U.S. Food and Drug Administration announced Tuesday.

Seniors aged 65 years and older can get a booster at least four months following their first dose of the bivalent vaccine, which protects against both the original and omicron strains of COVID-19, the FDA said. People with weakened immune systems can get a booster at least two months after their last vaccine dose, based on their doctor's judgment, the agency added.

The FDA announcement was part of an overall effort to simplify the COVID-19 vaccine schedule for Americans, the agency said. In its Tuesday announcement, the FDA also rescinded its emergency use authorization for the original Moderna and Pfizer mRNA vaccines, which are credited with saving tens of millions of lives during the pandemic. Only the bivalent vaccines will be available going forward, the FDA said.

Adults and children who have only gotten the original vaccine remain eligible for a dose of bivalent vaccine manufactured by either Moderna or Pfizer. Roughly 75 percent of Americans younger than 65 years are eligible for a bivalent vaccine dose but have not gotten the booster, Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said during a Tuesday morning media briefing.

People who remain unvaccinated now only need to get one dose of the bivalent vaccine, rather than the two-shot series associated with the original vaccines, the FDA said. Unvaccinated children ages 6 months to 5 years can receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer bivalent vaccine, the agency said.

The FDA announcement did leave the door open for future boosters, in case a new COVID-19 variant starts tearing through the United States. An advisory committee in June will review the COVID-19 strain composition expected for the fall and weigh whether another booster dose will be needed in the fall, the agency said.

More Information

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El Comité de Medicamentos de Uso Humano de la Agencia Europea de Medicamentos (EMA, por sus siglas en inglés) ha dado su visto bueno a la  vacuna contra la  covid de Hipra, la vacuna española conocida comercialmente como Bimervax, como dosis de refuerzo en mayores de 16 años que hayan sido vacunadas previamente, al menos seis meses antes, con una vacuna de Pfizer o Moderna.

La EMA concluyó que ya se dispone de datos suficientemente sólidos sobre la calidad, seguridad e inmunogenicidad de la vacuna de Hipra para recomendar su autorización de comercialización en la UE. Hipra contiene una proteína producida en laboratorio que consiste en parte de la proteína de espiga del SARS-CoV-2 de las variantes Alfa y Beta del virus. El perfil de seguridad de la vacuna de Hipra es comparable al de otras vacunas contra la covid. Los efectos secundarios más frecuentes observados con Bimervax fueron dolor en el lugar de la inyección, dolor de cabeza, cansancio y dolor muscular. Suelen ser de leves a moderados y desaparecen a los pocos días de la vacunación.

El ministro de Sanidad, José Miñones, ha valorado este jueves el aval de la EMA a la vacuna española como dosis de refuerzo contra la covid-19 porque supone "un hito" sin precedentes que ayudará a seguir luchando contra la pandemia en todo el mundo...Leer más

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