thoughtportal reblogged
PLEASE SPREAD THIS AROUND TO KEEP COVID SHOTS FREE FOR THE UNINSURED IN THE USA
Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.
“The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by ModernaTX Inc. and Pfizer Inc.
What You Need to Know
- Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, 3 weeks apart.
- Individuals who have been vaccinated only with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least 3 weeks after the previous dose.
- Those who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least 2 months after the last dose of a COVID-19 vaccine.
The FDA assessed manufacturing and nonclinical data to support the change to the 2024-2025 formula. The updated vaccine is manufactured using a similar process as previous formulas of this vaccine. Individuals who receive this vaccine may experience similar side effects as those reported by individuals who received previous formulas of this COVID-19 vaccine and as described in the fact sheets.
The FDA has determined that the updated Novavax COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older.
As part of today’s action, the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use.
The FDA granted the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to Novavax Inc. of Gaithersburg, Maryland.
thoughtportal reblogged
"University of Houston researchers make nasal vaccine that prevents COVID from spreading"
For reasons I don't understand, I'm having trouble linking directly to this Houston Chronicle post. But here's most of the text. (The URL's at the bottom if you want to try it.)
A team of researchers from the University of Houston have developed a new vaccine to treat and prevent the spread of flu and multiple coronavirus strains. Through two nasal sprays — an immune activating therapeutic treatment and a new vaccine — the team of UH researchers have not only broken ground on vaccinating against SARS-CoV-2 and the flu virus, but also on creating a universal coronavirus vaccine. Dr. Navin Varadarajan, who leads the lab behind the nasal sprays, said the new vaccine will be a game-changer to the “major obstacle” of current vaccines, which can prevent people from serious illness, but not stop them from spreading the disease to others. “They can (current vaccines) keep you out of the hospital, but it doesn’t stop you from spreading it to vulnerable people,” Varadarajan said. On top of providing a way to stop the spread of COVID to those most at risk — the elderly and immunocompromised — the new nasal vaccine is a crucial step forward in the goal of fighting viral evolution. It’s natural for viruses to change and evolve — and SARS-CoV-2, the virus that causes COVID-19, is no exception. As viruses spread farther and faster, they can better adapt to their environment. Successful variants beat out weaker ones, which can lead to easier transmission or worsened disease. While many viral variants have minimal impact, over time viruses become stronger against existing vaccines. SARS-CoV-2 resides in the nose, and since existing vaccines are intramuscular, meaning they are administered through a shot in the arm, the virus is not actually eliminated from the body. NanoSTING-SN, on the other hand, hits “the last mile” of the nose, which prevents the disease from spreading, Varadarajan said. It’s also a pan-coronavirus nasal vaccine, meaning it works against the infection and disease of all viruses in the coronavirus family. In animals, the nasal vaccine was 100% effective in stopping transmission of the Omnicron variants of concern to unvaccinated hosts. Despite the wide-use of Pfizer and Moderna, viral evolution of the disease forces scientists to keep updating existing vaccines. To Varadarajan, the nasal vaccine can also stop the cyclical need to create more COVID boosters — a method he not only says doesn’t get to the heart of the problem, but also anticipates the general public will be less willing to sign on board for.
The article URL:
A 4-year-old from Detroit has a confirmed case of the measles, and potentially exposed others while seeking treatment for the highly infectious virus at DMC Children's Hospital of Michigan, an urgent care center and a pharmacy in the city, the Detroit Health Department announced Wednesday.
It is Michigan's fifth documented measles case this year.
The child was unvaccinated, said Dr. Claudia Richardson, the city health department's medical director, and had no history of international travel. Measles is so contagious, 90% of unvaccinated people who are exposed to the virus will become infected.
City health officials said they are working with the state health department to investigate where the child might have been exposed to the virus. So far, however, the case appears to be isolated, Richardson said.
"This is definitely an ongoing investigation," she said, "so we're in the middle of that. At this time, we do not have a source of the infection."
The child was not hospitalized, Richardson said, but was treated in the emergency department at Children's Hospital and is now following isolation protocol.
Anyone who was at the following places at these times and dates may have been exposed to the virus:
- From noon to 3 p.m. April 1 at Acadian Urgent Care, 2117 Springwells, Detroit.
- From 1:45-4 p.m. April 1 at the Rite Health Pharmacy, 5851 W. Vernor, Detroit.
- From 5-10 a.m. April 3 in the emergency department at DMC Children’s Hospital of Michigan, 3901 Beaubien Blvd., Detroit.
Children’s Hospital of Michigan did not respond to questions from the Free Press about how many people may have been exposed to the measles in the emergency department on April 3 or about how the hospital is notifying them.
Health leaders urge anyone who might have been exposed to the virus April 1-3 to monitor themselves for symptoms for 21 days. If symptoms develop, call ahead before visiting a doctor, urgent care center or hospital emergency room so precautions may be taken to avoid exposing others.
"We're ... doing our routine communicable disease investigation, which requires us to reach out to anyone that may have had direct contact. So far, all we know are family members," Richardson said, adding: "We are trying to get the word out the best we can."
What are the symptoms of measles?
Measles symptoms typically begin seven to 14 days after exposure, but can first appear as long as 21 days after exposure and can include:
- High fever that could reach 104 degrees or higher.
- Cough.
- Runny nose.
- Red, watery eyes (conjunctivitis).
- Tiny white spots on the inner cheeks, gums and roof of the mouth called Koplik Spots, which usually appear two to three days after symptoms begin.
- A rash that starts on the face and spreads to the trunk, arms and legs, typically three to five days after symptoms begin. The rash is red, raised and blotchy.
"Infected people can spread measles before noticing any symptoms, including four days before and four days after the rash appears," Denise Fair Razo, chief public health officer for the Detroit health department, said in a statement. "Our best advice is to get vaccinated against measles if you have not already done so. It is part of the two-dose measles, mumps, rubella (MMR) series of childhood vaccines."
2 doses of MMR vaccine are 97% effective at preventing measles
Measles infections are preventable with widespread vaccination. Two doses of the measles, mumps and rubella vaccine (MMR), offer 97% protection from infection. A single dose is about 93% effective.
However, in Michigan, immunization rates have fallen to 66% among Michigan toddlers — the lowest point in more than a decade for recommended childhood immunizations, according to MDHHS.
What is the recommendation for measles vaccinations?
The U.S. Centers for Disease Control and Prevention recommends:
- A first dose of the MMR vaccine for children ages 12-15 months old, with a booster dose administered between ages 4 and 6.
- Anyone born in or after 1957 without evidence of immunity against measles or documentation of having been vaccinated with two doses of MMR vaccine should get vaccinated.
- Two doses are recommended for adults at high risk, such as international travelers, college students and health care personnel born during or after 1957.
- People exposed to measles who cannot document immunity against the virus should get post-exposure prophylaxis — a dose of the vaccine to potentially provide protection within 72 hours of initial exposure, or immunoglobulin within six days of exposure.
How serious is a measles infection?
Measles can cause serious illness, long-term disability and death in people of all ages.
About 1 in 5 people who get the measles end up hospitalized, according to the CDC, and 1 in 20 kids with measles develops pneumonia. Roughly 1 out of every 1,000 children who have measles infections will also have encephalitis. Brain swelling from encephalitis can lead to convulsions, permanent hearing loss, intellectual disability and death.
Anywhere from 1 to 3 out of every 1,000 children with measles dies from respiratory or neurologic complications from the virus.
"We've had the vaccine since 1963, and before the vaccine was available, every year across the U.S., between 400 and 500 people died," Dr. Natasha Bagdasarian, Michigan's chief medical officer, told the Free Press for a previous article. "Four hundred to 500 people may not seem like ... huge numbers, but it is a lot, especially if you're talking about your loved one or your child."
Notification too late for post-exposure treatment
The Detroit child's measles case was confirmed Tuesday, Richardson said, but public notification was not made until Wednesday afternoon, when anyone who was potentially exposed to the virus would be outside the window for treatment with post-exposure prophylaxis to prevent infection.
A dose of the MMR vaccine can be administered 72 hours of initial measles exposure and immunoglobulin can be given intravenously within six days of exposure to potentially prevent illness, according to the CDC.
By Wednesday afternoon, that window had closed.
"We are out of both of those windows and ... we were going through the dates very rigorously," Richardson said.
What can be done now, she said, is to educate the public about the potential exposures, what to do if they develop symptoms, and to urge vaccination.
"That's where we're focusing," Richardson said. "When situations like this arise, it brings preventable diseases such as measles to the forefront. ... It's the perfect opportunity for us to stress the importance of vaccination."
The Detroit Health Department offers vaccinations for measles and all childhood vaccination series, plus COVID-19, flu and Mpox at its Immunizations Clinic at 100 Mack Ave. Hours are: 8:30 a.m.-4:30 p.m. Mondays-Fridays by appointment. Walk-ins are welcome from 9 a.m.-3 p.m. Late hours are available on the first and third Thursdays of each month, when the clinic is open 10 a.m.-6:30 p.m.
To learn more or to schedule, go to: www.detroitmi.gov/health or call 313-876-4667.
Michigan is not at outbreak status
This is the fifth known measles case in Michigan in 2024.
- Two cases were identified in March in Washtenaw County. The second person is believed to have been exposed to the virus at Trinity Health Ann Arbor's waiting and triage area, where another Washtenaw County resident contagious with measles had gone for care.
- An adult from Wayne County who had traveled internationally and had no record of measles immunization had the virus in February.
- An Oakland County child who was unvaccinated and had traveled internationally was the first known case of measles in Michigan this year, state health officials announced Feb. 23.
Although Michigan health leaders have reported five measles cases since February, the situation doesn't yet rise to the level of an outbreak, according to the definition set by the CDC, which identifies an outbreak as a chain of transmission including three or more cases linked in time and space.
As of April 4, there have been 113 cases of measles in the U.S. this year, according to the CDC, and 58% of the people infected with the virus nationally in 2024 have been hospitalized for isolation or for management of measles complications.
Among those 113 cases, the CDC has recognized seven measles outbreaks, which include 73% of cases identified in 2024.
Comparatively, there were 58 total U.S. measles cases in 2023 and four outbreaks.
Overall, the new FDA decision “comes at a time when COVID-19 cases are once again climbing. Now, most people 6 months or older in the U.S. are eligible to receive this season’s COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,” Albert Bourla, chairman and chief executive officer at Pfizer, said in a news release.
The updated vaccines are approved for people 12 and older and are authorized under emergency use for individuals 6 months through 11 years old.
“COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season,” Stéphane Bancel, CEO of Moderna, said in a news release Monday.
Under the Affordable Care Act, most insurance plans are covering the full cost of vaccines, without co-pays. So most insured people will be able to get the updated Covid-19 vaccine at their doctor’s offices or pharmacies, such as CVS or Walgreens, at no cost.
Make your voice heard and ask the CDC to:
- Recommend updated COVID vaccines for all ages AND
- Strengthen our vaccine drive by recommending more frequent boosting (at least every six months) and more frequent updates to the vaccines.
CDC’s ACIP Meeting Information (Including how to register to make an Oral Public Comment): https://www.cdc.gov/vaccines/acip/meetings/index.html
Vaccination is a mainstay of a multilayered approach to COVID, providing protection against both acute disease and Long COVID. The current annual approach is inappropriate, as COVID transmission does not show a seasonal pattern. Under the current “simplified schedule,” far too many people are left without adequate protection as vaccine efficacy wanes significantly four to six months following vaccination. A more frequent booster approach will also lower barriers in vaccination for people at high risk of severe consequences of COVID infection.
The magnitude and quality of a key immune cell’s response to vaccination with two doses of the Pfizer-BioNTech COVID-19 vaccine were considerably lower in people with prior SARS-CoV-2 infection compared to people without prior infection, a study has found. In addition, the level of this key immune cell that targets the SARS-CoV-2 spike protein was substantially lower in unvaccinated people with COVID-19 than in vaccinated people who had never been infected. Importantly, people who recover from SARS-CoV-2 infection and then get vaccinated are more protected than people who are unvaccinated. These findings, which suggest that the virus damages an important immune-cell response, were published in the journal Immunity.
The study was co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and led by Mark M. Davis, Ph.D. Dr. Davis is the director of the Stanford Institute for Immunity, Transplantation and Infection and a professor of microbiology and immunology at Stanford University School of Medicine in Palo Alto, California. He is also a Howard Hughes Medical Institute Investigator.
Dr. Davis and colleagues designed a very sensitive tool to analyze how immune cells called CD4+ T cells and CD8+ T cells respond to SARS-CoV-2 infection and vaccination. These cells coordinate the immune system’s response to the virus and kill other cells that have been infected, helping prevent COVID-19. The tool was designed to identify T cells that target any of dozens of specific regions on the virus’s spike protein as well as some other viral regions. The Pfizer-BioNTech vaccine uses parts of the SARS-CoV-2 spike protein to elicit an immune response without causing infection.
The investigators studied CD4+ and CD8+ T-cell responses in blood samples from three groups of volunteers. One group had never been infected with SARS-CoV-2 and received two doses of the Pfizer-BioNTech COVID-19 vaccine. The second group had previously been infected with SARS-CoV-2 and received two doses of the vaccine. The third group had COVID-19 and was unvaccinated.
The researchers found that vaccination of people who had never been infected with SARS-CoV-2 induced robust CD4+ and CD8+ T-cell responses to the virus’ spike protein. In addition, these T cells produced multiple types of cell-signaling molecules called cytokines, which recruit other immune cells—including antibody-producing B cells—to fight pathogens. However, people who had been infected with SARS-CoV-2 prior to vaccination produced spike-specific CD8+ T cells at considerably lower levels—and with less functionality—than vaccinated people who had never been infected. Moreover, the researchers observed substantially lower levels of spike-specific CD8+ T cells in unvaccinated people with COVID-19 than in vaccinated people who had never been infected.
Taken together, the investigators write, these findings suggest that SARS-CoV-2 infection damages the CD8+ T cell response, an effect akin to that observed in earlier studies showing long-term damage to the immune system after infection with viruses such as hepatitis C or HIV. The new findings highlight the need to develop vaccination strategies to specifically boost antiviral CD8+ T cell responses in people previously infected with SARS-CoV-2, the researchers conclude.
Six and a half million dead. More than a hundred times that infected. The Covid-19 pandemic has wreaked havoc across the globe. But in the final months of the third year of this health crisis, some now claim it’s all over.
Scientists with key roles in the global response join Claudia Hammond to consider the evidence behind the declarations that the pandemic has finished and they set out how, officially, this global health crisis will be brought to an end.
They reject claims that the pandemic is over, but say the emergency phase of this global health crisis is coming to a close.
But only if countries remain vigilant and maintain pandemic preparedness.
If vaccines reach arms, if treatments are shared equally and if nations re-introduce public health measures like mask wearing and social distancing when the inevitable new waves (and potential new variants) emerge, the appalling loss of life we saw at the beginning of the pandemic, they tell Claudia, won’t be repeated.
There are stark warnings too that the dramatic global drop in the sequencing of virus samples (which enables us to see how the virus is evolving) is posing a serious risk.
We can’t react to a new threat, Claudia’s panel say, if you can’t see it. Sequencing, as well as testing, has fallen by 90% since January this year, from 100,000 weekly sequences ten months ago to less than 10,000 now. This severely limits the ability to track the known variants (currently 200 sub-lineages of the Omicron variant).
Produced in collaboration with Wellcome and recorded in front of a live audience in Wellcome’s Reading Room in London, Claudia’s expert panel includes Dr Maria Van Kerkhove, the World Health Organisation’s Technical Lead for Covid-19, Professor Salim Abdool Karim, co-chair of the south African Ministerial Advisory Committee on Covid-19 and a member of the Africa Task Force which oversees the African continent’s response to the virus and Professor Sir Jeremy Farrar, the Director of Wellcome and a former adviser to the UK government on its Covid response.
The Food and Drug Administation authorized reformulated versions of the Moderna and Pfizer-BioNTech vaccines that aim to protect against the omicron variant.
The new shots target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now. This double-barreled vaccine is called a bivalent vaccine.
"The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. ... We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in an agency statement. "The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations."
The Moderna COVID-19 vaccine is authorized for use as a single booster dose in people 18 and older. The Pfizer-BioNTech booster is authorized for people 12 years and up. People are eligible for the new boosters two months after completing their initial vaccination or their last booster shot.
The federal government plans to make the boosters available starting next week. In advance of the FDA's decision, Dr. Ashish Jha, the White House COVID-19 Response Coordinator told NPR that the new boosters represented "a really important moment in this pandemic."
Public health officials hope they will help contain a possible fall and winter surge.
New coronavirus boosters are just around the corner following authorization Wednesday by federal regulators. The updated shots are designed to provide a stronger shield against the BA.4 and BA.5 omicron subvariants still causing tens of thousands of infections and hundreds of deaths every day in the United States.
The boosters will be part of a campaign by the federal government, to be kicked off within days, to persuade Americans to bolster their immune defenses before a potential surge in covid-19 cases as cooler weather arrives in the fall.
But the updated boosters have generated some controversy and confusion. Here’s what you need to know:
When will the shots be available?
The boosters, after receiving emergency use authorization from the Food and Drug Administration, now have to get the blessing of the Centers for Disease Control and Prevention and its advisers. That review is scheduled for Thursday. If all goes as expected, some shots could be available this weekend, with more available right after Labor Day.
Where can I get one and how much will it cost?
The new boosters, which are intended as single shots, will be available at the same places where the previous boosters and vaccines have been available — at doctors offices, hospitals, pharmacies and community health clinics.
Like the other coronavirus shots, the updated boosters have been purchased by the federal government and will be free to consumers.
Will the new boosters be more effective against the omicron variant?
That remains unclear at the moment.
The original vaccine, which hadn’t been updated since it became available in late December 2020, targeted the virus that emerged from Wuhan, China, a strain that is no longer circulating. Human data on the new recipe won’t be available until clinical trials are complete in the next several weeks or longer.
Mice studies, which are used in updating the influenza vaccine every year, showed a substantial increase in virus-fighting antibodies against the omicron mutations. FDA officials also considered human data from previous experimental bivalent vaccines. Agency officials and many other scientists believe the new booster, which includes components from the original vaccine as well as components zeroing in on BA.4 and BA.5, will be a better match for today’s threat.
The agency did not want to wait for clinical trials, which would have delayed deployment of the updated booster as cold weather approached. Officials said they are confident about the shot’s safety given the extensive use of mRNA vaccines.
“We are hoping this will really help us get on top of things” and perhaps encourage those who have not gotten any boosters to finally receive the shot, said Peter Marks, the FDA’s top vaccine official.
Jeanne Marrazzo, director of the infectious-diseases division at the University of Alabama at Birmingham, supports the FDA approach.
“I think it is going to be better,” Marrazzo said. “At least it reflects where the virus is going.”
“It’s a race against an evolving virus at a time when you are being asked to go back into the office and winter is coming,” Marrazzo added. “There is really no right answer, but with stakes being high, it’s better to err on side of offering the protection.”
Who are the boosters for?
The CDC is expected to recommend the shots for the same ages authorized by the FDA — 12 and older for the new booster from Pfizer and its German partner, BioNTech, and 18 and up for the Moderna booster. Officials are expected to consider use of the updated booster in younger children later. Anyone who has received the two-shot primary series of the mRNA vaccines and the single-shot Johnson & Johnson vaccine will be eligible, regardless of whether they received any — or all — of the recommended booster shots.
The existing vaccine will continue to be used, but only for the initial two-shot series of the mRNA, not as a booster.
If I just got a booster of the original vaccine, should I get the new one right away?
No. The FDA said people who recently received their initial vaccine or a booster should wait two months before getting the updated booster. Getting the new booster too soon could limit its effectiveness.
What are the side effects of the boosters?
Side effects are not expected to differ from those associated with the current vaccine, which include redness and swelling at the vaccine site, as well as occasional fatigue, headache and muscle soreness, according to the CDC. More serious reactions are rare.
