Category: Corona Virus Vaccine

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When will COVID-19 vaccines be available in California for fall/winter surge? - VC Star

BALTIMORE -- On Thursday the FDA approved updated COVID-19 booster shots from Moderna and Pfizer that would target the KP.2 strain of the coronavirus. Officials say KP.2 has spread rapidly these past few months, highlighting the warning as we head into fall and its respiratory hotbed.

"The virus is changing but also the infections that we get from past infections or past vaccines, wanes over time," Dr. Mandy Cohen, Director of the Center for Disease Control and Prevention said.

"Last fall and winter, 10% of the U.S. population had the flu at the peak of the respiratory illness season, more than 2500 people a week were dying from COVID-19," Jeff Nesbit, Assistant Secretary for Public Affairs at the U.S. Health & Human Services said.

Health officials especially want older Marylanders and those who are immunocompromised to make sure they get the updated annual booster, the flu shot, and the RSV vaccine to avoid a trip to the emergency room.

"We're talking about a vaccine that is continuing to evolve and it is likely that what's going to be there four or five months from now, will further evolve from where it is now," Dr. Peter Marks of the Food and Drug Administration said.

"So, you want to make sure you're getting the highest level of protection you possibly can going into [the] season where we know we will see more of the COVID virus circulating, the flu virus circulating," Cohen said.

Now that the updated booster has been approved, Moderna and Pfizer have already started shipping the latest vaccine. Officials are encouraging those most vulnerable to get it as soon as possible, while others can wait until October to maximize protection.

However, their message is to just get it done to protect yourself and others.

"Even though COVID is not the flu, being able to get that shot in the arm is what we really need to have happen, that's the point of this campaign here," Marks explained.

The Biden Administration announced that starting in late September four free COVID tests will be mailed to Americans, a one-two punch to keep people safe as we head into respiratory illness season.

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FDA approves updated COVID-19 booster shots, health officials urge Marylanders to get vaccinated - CBS News

The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been since January 2022. Wastewater surveillance, an early warning sign of COVID-19s spread in communities, demonstrates very high viral activity for COVID-19 across the U.S. indicating positivity rates could be even higher than reported test results. CDC recommends that everyone ages six months and older receive a 2024-2025 COVID-19 vaccine.

In advance of the respiratory virus season, the Department of Health and Human Services Aug. 19 launched a new public education campaign on common respiratory viruses and available vaccines including flu, COVID-19 and respiratory syncytial virus (commonly known as RSV).

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CDC: COVID-19 surging across the U.S. | AHA News - American Hospital Association

Though the United States may be past the peak of its latest COVID-19 surge, federal health officials are eying ways to reduce the spread of the virus over colder months and the holiday season, including a relaunch of free COVID tests by mail.

The announcement comes as health providers gear up immunization activities ahead of the main respiratory virus season. Officials from federal agencies shared their outlooks for the upcoming season, along with the status on the tools to prevent them, at a media briefing today.

Dawn O'Connell, JD, assistant secretary for preparedness and response at the Department of Health and Human Services, said that, starting in September, people can order four free COVID tests to be delivered through the mail.

This is the seventh round of free tests since 2021, and the mail delivery program, combined with year-round access at outlets such as community clinics, has so far delivered nearly 1.8 million tests.

They do no good sitting in medicine cabinets.

She urged people to order the tests as families move indoors as the weather cools and as people prepare for travel and the holidays. O'Connell also urged people to use them. "They do no good sitting in medicine cabinets."

CDC Director Mandy Cohen, MD, MPH, said the CDC's forecasting for the fall and winter suggests similar or lower numbers of peak hospitalizations for all three of the main respiratory illnesses: COVID, flu, and respiratory syncytial virus (RSV) infection.

She included a caveat, however, that assumptions could change, based on changes in SARS-CoV-2, the virus that causes COVID-19, which evolves faster than flu, and other factors.

At today's briefing, health officials fielded questions about COVID vaccine access to lower-income and uninsured people, as well as regarding who should be vaccinated, especially given the current level of high activity.

The federal government's bridge access program, launched last September to provide broad COVID vaccine access to millions of uninsured Americans, has now ended due to budget recissions. But at today's briefing, Cohen announced that the CDC has identified $62 million in funding for state and local health departments to obtain the vaccine.

She also added that free access to the antiviral drug Paxlovid through an assistance program run by Pfizer is available until the end of 2024 and that both Pfizer and Merck have assistance programs for uninsured and underinsured people.

When asked about the timing of updated vaccines, for which approval came yesterday for the two mRNA vaccines, Peter Marks, MD, who directs the Food and Drug Administration's Center for Biologics Evaluation and Research, said officials are always looking for concerning mutations and whether a vaccine update is urgently needed. However, he said the main consideration currently is getting doses into patient's arms, and that fall vaccination drives are the most realistic way to ensure that many people are vaccinated and boost their immunity to the virus.

The only way to get long COVID is having COVID.

Health officials said COVID is still more dangerous than flu, and Marks emphasized that the vaccine's impact against getting COVID is also a way to prevent long COVID. "The only way to get long COVID is having COVID," he said.

For respiratory viruses as a whole, activity is still low, but wastewater levels for COVID are still at the very high level, the CDC said today in its latest data updates. Levels are still highest in the West, which continues to show a declining trend. The South and Midwest are also showing downward trends.

The latest data from WastwaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, shows that SARS-CoV-2 detections remain high in all regions, but with a downward trend over the past 3 weeks nationally and in the Northeast, South, and West.

Meanwhile, test positivity for COVID was at 18% nationally, the same as the previous week, with the highest levels in Texas and surrounding states. Emergency department visits for COVID were down a bit, and deaths remained level.

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Feds announce new round of free COVID tests - University of Minnesota Twin Cities

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When will COVID-19 vaccines be available for fall-winter season? What to know amid surge - Tennessean

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Health board member excluded from executive session after COVID-19 vaccine liability warning - wenatcheeworld.com

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FDA approves updated COVID-19 vaccines for upcoming fall and winter season - ABC News

The updated mRNA vaccines target a strain called KP.2, which is circulating now and is expected to ramp up in the fall and winter months.

PORTLAND, Ore. On Thursday, the Food and Drug Administration (FDA) approved two new COVID-19 vaccines one from Moderna and one from Pfizer marking the third time the vaccines have been updated to keep up with new strains of the virus.

Leaders with the Oregon Health Authority (OHA) said the approval, which came earlier than last year, was not unexpected. The mRNA vaccines target a strain called KP.2, which is circulating now and is expected to ramp up in the fall and winter months. OHA couldn't give an exact timeline of when Oregonians would be able to get the updated vaccines, but did say they'd be available in the coming weeks.

"I think for people that are on the fence and say, 'Oh, a new FDA vaccine, I'm going to wait,' this is the same vaccine that we have been using for the past several years," said Dr. Dean Sidelinger, OHA's health officer and state epidemiologist. "It is updated to fight some of the more recent variants, but the technology, the proven science behind this vaccine, has been with us for several years."

Health officials stress the protection they'll offer, especially against severe disease.

"Certainly it's much safer and much less miserable to get a COVID vaccine than it is to have to recover from COVID to get that protection," Sidelinger said, "Because even those people who aren't in the hospital, if you recently have it, you know, have reported a lot of brain fog and really bad fatigue."

Sidelinger explained that those most at risk should get the shots sooner, including older adults, younger children and people who are immunocompromised.

"But all of us, you know, six months and older should consider getting this vaccine. The protection starts within weeks after getting the vaccine, so if you're someone who's at higher risk with COVID still circulating at fairly high levels, now it will offer you protection from the summer wave," Sidelinger said.

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Health leaders expect new COVID-19 vaccines to be available in Oregon in coming weeks - KGW.com

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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New COVID-19 booster shots have been approved. When should you get one? - Science News Magazine

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.

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Updated COVID shots from Pfizer, Moderna cleared by FDA - BioPharma Dive