COVID-19 nasal spray a potential ‘game changer’ https://www.newsnationnow.com/health/covid-19-nasal-spray-a-potential-game-changer/ Researchers at UC Berkeley are developing a nasal spray that can prevent and treat COVID-19, with early data showing it could be a “game changer” in the fight against the virus. While the vaccines developed have largely targeted the spike protein on the outside of the virus, the nasal spray focuses on the heart of the virus instead. Data from first sets of tests show the spray appears to work against all current variants and future variants. Professor Anders Naar, one of the lead researchers, explained that’s because the spray targets the virus’ RNA strain in an attempt to block the virus from duplicating in human cells. “The virus is basically like a trojan horse,” Naar said Sunday on “NewsNation Prime.” “It injects RNA into a cell … and turns into its personal copy machine.” Targeting the RNA strain would turn off that copy machine, Naar said. The hope is that a nasal spray can make major headway in COVID-19 prevention efforts because it is easy to manufacture, ship and store. Unlike vaccines that have to be stored at cold temperatures, a nasal spray would be able to survive at room temperature. “You can basically get this to people where there is no refrigeration or freezing capacity,” Naar said. It might also appeal to the vaccine-hesitant population because of its easy application. Tests have been conducted on mice and hamsters, and no adverse effects have been identified, Naar said. The next phase of research is animal trials and then human trials. “We’re probably a year or two away from actually having this deployed if everything goes well,” Naar said. Testing has also shown that the spray can reduce symptoms for those already infected with coronavirus. For Naar and his fellow researchers, they say it’s a potential game changer. One doctor who is following the developments is Peter Chin-Hong, an infectious disease specialist at UCSF Medical Center. “On paper it seems great, I’m very excited about it moving onto the next level,” Chin-Hong said. “I’m very hopeful about it, in terms of it not being spike-protein dependent, portable and easy-to-scale globally and being easy to administer. Not having human studies yet gives me some pause, but if I were an investor, I’d want to invest in it. It checks all the boxes, except how it performs in humans, that remains to be seen.”
Britain first to approve Omicron-adapted COVID shot https://www.reuters.com/world/uk/va...ccine-wins-first-approval-britain-2022-08-15/ Britain, the first country to approve a coronavirus vaccine in late 2020, has now also given the first green light to a variant-adapted shot that targets both the original and Omicron version of the virus. The UK medicines regulator (MHRA) gave the so-called bivalent vaccine made by U.S. drug company Moderna (MRNA.O) conditional approval as a booster for adults on Monday. Britain's Joint Committee on Vaccination and Immunisation (JCVI) is now expected to soon issue a recommendation on how the vaccine should be deployed in the country. The MHRA's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said. Moderna said in June trial data showed that when given as a fourth dose, the variant-adapted shot raised virus-neutralizing antibodies by eight-fold against Omicron. read more The MHRA also cited an exploratory analysis in which the shot was found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5. No serious safety concerns were identified with this new formulation, the agency added. The UK government said last month a vaccine booster programme would begin in "early autumn" and that shots would offered to over 50s, individuals in clinical risk groups, frontline workers and care homes staff. read more While existing COVID-19 vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved. "The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA Chief Executive June Raine said in a statement. "What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve." The UK Health and Security Agency (UKHSA), which oversees vaccine procurement among other responsibilities, did not immediately respond to a request for comment. European Medicines Agency (EMA) officials expect COVID variant-adapted vaccines to be approved in the European Union by September, and have signalled the regulator is open to using shots targeting the older BA.1 variant this autumn, given those specifically targeting newer subvariants are further behind in clinical development. In contrast, the U.S. Food and Drug Administration (FDA) has said it will seek the specific inclusion of the newer BA.4 and BA.5 offshoots of Omicron in any new shots used domestically. Apart from Moderna, partners Pfizer Inc (PFE.N) and BioNTech (22UAy.DE) have also been testing versions of their mRNA vaccine modified to combat Omicron variants. Meanwhile, Sanofi (SASY.PA) and partner GSK (GSK.L) are working on a protein-based vaccine that targets the Beta subvariant, which dominated for some time last year.
Covid mRNA Vaccines Safe For Pregnant People, New Study Reinforces https://www.forbes.com/sites/madeli...-people-new-study-reinforces/?sh=4cae0547a62a Topline In a finding that provides more reassurance of the safety of Covid-19 messenger RNA vaccines for pregnant people, a Canadian study found pregnant women—who are at higher risk for more severe coronavirus infections—actually experienced fewer significant health problems after getting vaccinated than non-pregnant people of the same age. The observational study, published in the journal Lancet Infectious Diseases, compared side effects for pregnant women after receiving Pfizer and Moderna mRNA vaccines to a control group of vaccinated non-pregnant women of the same age as well as a group of unvaccinated pregnant women. Researchers found 7.3% of pregnant women experienced health issues requiring time off from work or medical attention like headaches and fatigue within a week of a second dose of the Pfizer and Moderna vaccines, compared to 11.3% of non-pregnant vaccinated women. The most common health problems for pregnant women after getting the second dose included a general feeling of being unwell, headaches and migraines and respiratory tract infections. Among all three groups, there was no significant difference in rates of more serious health problems that required professional medical attention, researchers found, though they noted one study limitation was the sample population, which was largely white. Pregnant women have gotten vaccinated at lower rates than non-pregnant women because of concerns about safety, and such studies can help inform them about potential vaccine side effects as well as the overall safety of the shots, study author Manish Sadarangani, the head of the Vaccine Evaluation Center at British Columbia Children’s Hospital Research Institute, said in a statement. Tangent Vaccination rates among pregnant women in the United States have climbed over the past year, according to data from the Centers for Disease Control. Roughy 45% of pregnant women were fully vaccinated against Covid as of mid-July 2021, compared to some 71% of pregnant women at the end of July 2022. Key Background The study adds to a growing body of research suggesting Covid mRNA vaccines are safe for pregnant women and not linked to an increased risk of miscarriage, preterm labor, or other negative birth outcomes. The Lancet study is also one of the first to compare pregnant women to both non-vaccinated pregnant women and vaccinated non-pregnant women. Pregnancy puts women at a higher risk for severe Covid infections including hospitalization, ventilation and death because of physiological changes to women’s immune systems and heart and lung health, researchers noted. Women are also at a higher risk of adverse pregnancy health outcomes as a result of Covid infections, including hypertension, preeclampsia, impaired fetal growth and preterm birth. Still, vaccination uptake among pregnant women lagged in the early stages of the coronavirus vaccine rollout because of data availability, researchers noted, while misinformation about the safety of the shot for pregnant women may also have increased vaccine hesitancy. Surprising Fact Some research suggests pregnant women who are vaccinated against Covid during their pregnancies may even pass down their coronavirus antibodies to their children. One recent study found 57% of 6-month-old infants whose mothers were vaccinated during their pregnancy had antibodies against the coronavirus, compared to 8% of infants whose mothers had a coronavirus infection during pregnancy.
BA.5 boosters could be here in the next 3 weeks, says Dr. Jha: ‘These are substantial upgrades in our vaccines’ https://www.cnbc.com/2022/08/18/dr-ashish-jha-covid-ba-5-booster-shots-could-be-just-weeks-away.html Dr. Ashish Jha has an updated prediction for when Covid booster shots targeting the omicron’s BA.5 subvariant could be available: within the next three weeks or so. “We’re going to know more about this in the upcoming weeks and these vaccines will become available by early to mid-September,” Jha, the White House’s Covid response coordinator, said at a virtual event hosted by the U.S. Chamber of Commerce Foundation on Tuesday. Jha’s timeline is the most specific estimate to date, following comments in prior months from health officials signaling a potential rollout in September or October. He noted that while the booster shots are expected to sail relatively smoothly through vetting from the U.S. Food and Drug Administration and Centers for Disease Control and Prevention, any authorization hiccups could delay that release date. The booster shots being considered by the FDA and CDC are made by both Moderna and Pfizer, and are known as “bivalent” shots — which means they target two separate strains of the coronavirus. In this case, the shots target both the original Covid strain and omicron’s BA.5 subvariant, which currently represents 85% to 90% of all U.S. cases, according to Jha. Jha emphasized that BA.5 is “incredibly immune evasive” and contagious, fueling breakthrough cases among vaccinated individuals and reinfections in those who had the virus just months prior. The subvariant could wreak more havoc in the fall as vaccine immunity wanes and people spend more time indoors, making updated shots a potentially valuable tool for nationwide protection. “The big picture, bottom line, is these are substantial upgrades in our vaccines, in terms of their ability to prevent infection, prevent transmission and certainly to prevent serious illness,” Jha said. “And those vaccines are coming very, very soon.” A CDC spokesperson tells CNBC Make It that the updated shots will be available as a booster dose for people who have completed their primary vaccination series, regardless of how many other boosters they have or haven’t received. The agency says it expects Pfizer’s updated booster to be authorized for people ages 12 and older, and Moderna’s updated shot to be for people ages 18 and older. Younger pediatric age groups will follow later, the spokesperson says. On Monday, the United Kingdom authorized an updated shot from Moderna, becoming the world’s first country to authorize a bivalent Covid booster. The U.K.’s booster formulation is slightly different than the one being considered in the U.S.: It combats the original strain and Covid’s original omicron variant. Clinical trials showed that it still generated a “good” immune response to BA.5, according to a U.K. regulatory agency. The U.K. approval indicates that the U.S. may not be far behind: The two countries have had close timelines for green-lighting Covid shots over the past two years, from the original vaccines in December 2020 to booster shots in September 2021. At the Chamber event, Jha emphasized the importance for every American to get a new booster as soon as they’re eligible — whether they think they’re at risk or not. “It’s going to be really important that people this fall and winter get the new shot. It’s designed for the virus that’s out there,” Jha said. “All of the data suggests it should be highly effective against the new variants.”
Americans may soon have to pay for COVID vaccines themselves rather than getting them for free https://fortune.com/2022/08/19/free-covid-19-vaccines-may-be-coming-to-an-end-for-americans/ The U.S. government is planning to stop paying for COVID-19 vaccines and treatments, and shift the bill onto the health care industry and eventually the consumer—possibly making it one of the first countries to end the practice of giving out coronavirus vaccines for free. The Department of Health and Human Services will hold a planning session on Aug. 30, the Wall Street Journal reported, to bring together representatives from the health care industry as well as state health departments, to discuss the commercialization of COVID-19 treatments. The move comes a few days after White House COVID-19 Response Coordinator Dr. Ashish Jha confirmed on Tuesday that the Biden Administration had taken steps to get past the crisis phase of the pandemic and stop buying vaccines, treatments, and tests as early as fall. “One of the things we’ve spent a lot of time thinking about in the last many months…is getting us out of that acute emergency phase where the U.S. government is buying the vaccines, buying the treatments, buying the diagnostic tests,” Jha said at an event sponsored by the U.S. Chamber of Commerce Foundation. “My hope is that in 2023, you’re going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead,” Jha said. It was always the plan under both the Trump and Biden administration to push the pricing and coverage control of COVID-19 vaccines and treatments onto the healthcare industry. As COVID cases drop and the pandemic response funding runs short, the U.S. is determined to privatize COVID-19 treatment by the end of the year. “We’ve known at some point we’d need to move over into the commercial market, and we’re approaching that time now,” Dawn O’Connell, assistant secretary at HHS for preparedness and response, told the WSJ. How it will work The move to shift payments for COVID-19 drugs to the commercial market may still take months. At the upcoming HHS meeting, company representatives and officials still need to discuss reimbursement and coverage, as well as regulatory, market dynamic, and equity issues. Insurers and pharmacy benefit managers negotiating with drug manufacturers means prices would rise higher than what the federal government paid. With each insurer paying for the vaccine, premiums are also likely to rise for the consumer, Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, told the WSJ. “Without the government purchasing vaccine doses in advance, the U.S. may fall behind other countries in getting quick access to boosters and new variant-specific vaccines,” Levitt said. A key point of the meeting will be discussing how the 30 million uninsured Americans will access COVID-19 resources. “Right now everybody can walk into CVS and get a vaccine. I want to make sure when we make this transition, we don’t end up in a point where nobody can get a vaccine because we didn’t get the transition right,” Jha said at the event on Tuesday. The move also might create a challenge for those suffering from long COVID, which is known to increase the risk of cognitive deficit (also known as brain fog), psychotic disorders, and epilepsy for two years after a COVID diagnosis, according to a study published in The Lancet Psychiatry on Wednesday. Wrestling for funding The Biden administration asked Congress in April for $10 billion to fund the ongoing pandemic response efforts. After failing to persuade Congress, White House officials said they would have to repurpose federal COVID-19 funds to supply more antiviral pills and vaccines. As funding in government faltered, pharmaceutical companies have been eagerly watching the situation, as commercialization of COVID-19 treatments could bring a windfall worth billions of dollars in profits. The 10 largest pharmaceutical companies by revenue brought in a collective $734.8 billion in revenue and $130.6 billion in profits in 2021, according to the 2022 Fortune Global 500, from the 12.2 billion doses that have been administered globally as of July 17.
FDA authorizes Novavax COVID vaccine for adolescents https://thehill.com/policy/healthcare/3609936-fda-authorizes-novavax-covid-vaccine-for-adolescents/ The Food and Drug Administration (FDA) on Friday cleared Novavax’s COVID-19 vaccine for emergency use in adolescents, paving the way to expand eligibility for the fourth shot available in the United States. The two-dose regimen utilizes protein-based technology previously leveraged in vaccines to combat other viruses, offering an alternative for Americans skeptical of Pfizer and Moderna’s mRNA technology. Providers can begin administering the vaccine to people aged 12 through 17 after a sign off from the Centers for Disease Control and Prevention (CDC), which has already authorized the vaccine’s use for adults. The two doses are given three weeks apart. “Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 Vaccine, Adjuvanted will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season,” Novavax President Stanley Erck said in a statement. “We hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination based on parents’ and caregivers’ familiarity with protein-based vaccines used in other disease areas,” he added. The FDA granted emergency use for adolescents after the company said its trial of 2,247 adolescents showed a primary efficacy of 78 percent. But Novavax conducted the trial last year, when the Delta variant was predominantly circulating in the United States. The White House has continued urging Americans to get vaccinated and boosted amid the spread of the BA.4 and BA.5 subvariants of omicron, but questions remain as to how the mutations could impact the vaccine’s efficacy. The FDA authorized Novavax’s vaccine for adults last month, which was followed by the CDC’s blessing nearly a week later. White House coronavirus response coordinator Ashish Jha said on Wednesday that regulators are expected to approve updated COVID-19 vaccine doses in “a few short weeks” for everyone over the age of 12. The shots are designed to target the two omicron subvariants currently circulating. Novavax’s COVID-19 shot helps prevent severe illness by injecting the human body with doses that contain the coronavirus spike protein. The company inputs genetic code that creates the spike protein into an insect virus, which replicates after infecting moth cells. The manufacturer then purifies and extracts the replicated spike proteins and injects them into humans. The process only requires regular refrigeration, compared to Pfizer and Moderna’s mRNA vaccines that require storage in colder temperatures. Those vaccines contain genetic instructions for human cells to create the spike protein and defend against future infections.
Omicron-specific Covid booster shots are just weeks away. Here’s who will—and won’t—be eligible https://www.cnbc.com/2022/08/20/omicron-specific-booster-shots-are-weeks-away-eligibility-guide.html Newly updated Covid booster shots designed to target omicron’s BA.5 subvariant should be available within in the next three weeks. That begs an important question: Who’s going to be eligible to get them? The short answer: anyone ages 12 and up who has completed a primary vaccination series, a Centers for Disease Control and Prevention spokesperson tells CNBC Make It. It’s unlikely to matter whether you’ve received any other booster doses or not before, the spokesperson says — but if you’re unvaccinated, you won’t eligible for the updated formula until you complete a primary series with the existing Covid vaccines. The longer answer is somewhat more complex, because it depends on which booster shots get approved and when. Pfizer’s “bivalent” shot, which targets both the original Covid strain and omicron’s BA.5 subvariant, is expected to be authorized first. The CDC says it’ll likely come with a wide eligibility swath: the full group of vaccinated Americans ages 12 and up. Moderna’s bivalent shot is expected to follow suit later, most likely in October. It’ll come with a somewhat narrower range of eligibility, at least at first: vaccinated people ages 18 and older. For both shots, younger pediatric age groups could become eligible later, the CDC says. Those projections are tentative, at least for now. A person familiar with the matter told NBC News on Wednesday that it’ll hinge on how much supply Pfizer and Moderna are able to manufacture and roll out by next month. If that supply is limited, the shots could first be available to those most at risk, such as the elderly and immunocompromised. Federal health officials believe the shots will provide the best level of protection against the highly transmissible BA.5 subvariant to date, especially in the fall and winter when a large wave of Covid infections is projected to hit the U.S. “It’s going to be really important that people this fall and winter get the new shot. It’s designed for the virus that’s out there,” Dr. Ashish Jha, the White House’s Covid response coordinator, said at a virtual event hosted by the U.S. Chamber of Commerce Foundation on Tuesday. (More at above url)