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    Gaithersburg, Maryland-based Novavax, which began developing its protein-based COVID-19 vaccine candidate almost two years ago, has officially filed for approval with the U.S. Food and Drug Administration for its use in the U.S. The final FDA filing Monday comes months after Novavax had originally intended, and, while it may seem the company is late to the vaccine game, it sees its vaccine filling a void, particularly internationally. It does not require sub-zero storage, making it potentially more accessible to developing countries and remote areas. It is also not an mRNA vaccine, such as those approved for Pfizer and Moderna. “We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said CEO Stanley Erck. The Novavax vaccine has shown an overall efficacy of 90% in clinical trials. It conducted two Phase 3 trials with 30,000 participants in the U.S. and Mexico and a trial with almost 15,000 participants in the U.K. To date, Novavax has received conditional approval authorization...
    WASHINGTON (AP) — Moderna says U.S. health regulators have given full approval to its COVID-19 vaccine after reviewing additional data on its safety and effectiveness. The decision Monday by the Food and Drug Administration comes after many tens of millions of Americans have already received the shot under its original emergency authorization. Full approval means the FDA has completed the same rigorous, time-consuming review for Moderna’s shot as dozens of other long-established vaccines. Pfizer’s COVID-19 vaccine received full approval last summer. Public health advocates initially hoped the distinction would boost public confidence in the shots. But there was no discernable bump in vaccinations after the Pfizer decision. (© Copyright 2022 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed.)
    NORTH TEXAS (CBSDFW.COM) – A new COVID treatment could be on the way. Pfizer asked the FDA to grant an emergency use authorization for its antiviral pill. It’s intended to treat unvaccinated people with mild to moderate COVID-19, who are at high risk for hospitalization or death. It would be an at-home treatment, with medication taken twice daily for five days. If given within three days of symptoms, it was shown to reduce severe outcomes by 89-percent. READ MORE: Dallas ISD Implements Employee Retention Incentive For 'Highly Qualified Staff'The pill works by keeping the virus from replicating. Pfizer did not provide details of any side-effects, but said reports of adverse events were about the same in the placebo group and the group that actually received the medication. The drug company reported no deaths in the patients who received the drug, compared to 10 who got the placebo. READ MORE: Missing 16-Year-Old Irving Girl Tammy Guadalupe Ferguson Found Safe“The more tools we have to address this, for being able to treat those who are not getting the vaccination for whatever reasons,...
    Advisers to the Food and Drug Administration recommended on Wednesday that children 5 to 11 receive the Pfizer-BioNTech vaccine. The FDA's advisory committee announced the decision after a study found that the benefits for children who receive inoculation far outweigh the potential risks of cardiac arrest symptoms , according to the Washington Post. The panel voted unanimously to support the Pfizer-BioNTech vaccine for children. Next, a group of advisers from the Centers for Disease Control and Prevention is expected to have a conference on Nov. 2 regarding the use of the vaccine for children, after which CDC Director Rochelle Walensky could give approval. CHINA TO BEGIN VACCINATING CHILDREN AS YOUNG AS 3 AGAINST COVID-19 If given the go-ahead by the CDC chief, medical facilities will be able to dish out doses of the two-dose vaccine to children as early as the first week of November. Pfizer and BioNTech submitted data to the FDA on Sept. 28 showcasing the effectiveness of the vaccine for children. The trial study of 2,268 participants found that the...
    Mario Tama/Getty Images Drugmaker Merck announced on Friday that it would soon seek approval from the U.S. Food and Drug Administration for a pill the company claims cuts the risk of hospitalization or death from Covid-19 by half. If approved by health officials, the drug, known as molnupiravir, would become the first oral medicine used to treat the virus, as all current authorized therapies require wither an IV or injection. Merck and its partner Ridgeback Biotherapeutics said early results in a clinical trial showed that patients who received the drug within five days of their Covid-19 symptoms had roughly half the rate of hospitalization and death as patients who received a placebo pill. The study examined 775 adults considered higher risk for severe disease that had mild-to-moderate coronavirus symptoms. “At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%,” Merck said in a news release. “7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo treated patients (53,377). Through Day 29, no deaths were reported...
    President Joe Biden received his booster shot on camera Monday after the Food and Drug Administration (FDA) authorized the additional vaccine for individuals aged 65 and older. The Biden administration’s prediction that the booster shot would be widely available by mid-September was derailed after the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices only approved the shot – specifically, the Pfizer vaccine – for the elderly population and those at risk of serious disease. The FDA authorized the shot for these groups as well as for anyone who is put at high risk of contracting the virus due to “frequent institutional or occupational exposure.” CDC director Dr. Rochelle Walensky overruled her agency advisory panel, recommending the vaccine for frontline workers in a decision that came overnight on Sept. 22. White House press secretary Jen Psaki noted Biden would get the booster shot soon after it became approved, and the White House announced Monday morning that the president would receive it later that afternoon. “I know it doesn’t look like it, but I am over 65 …...
    While many Americans have already received one of the three vaccines currently available in the U.S., others have refrained from taking a shot. According to the Centers for Disease Control and Prevention, 61.4% of the U.S. population 12 and older has been fully vaccinated, while 72.2% in that demographic have received at least one dose. Earlier this month, the U.S. Food and Drug Administration announced that the Pfizer-BioNTech vaccine secured the agency's approval for use in people ages 16 and older. This marked the first vaccine to secure full approval from the FDA. "The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age," the FDA noted.
    Press secretary John Kirby said Monday the Pentagon will now move to mandate Covid-19 vaccinations for all US service members since the Food and Drug Administration (FDA) has given full authorization to the Pfizer shot. 'We're going to move forward making that vaccine mandatory, we're preparing the guidance for the force right now,' Kirby said in a news briefing.  The FDA granted full approval to Pfizer-BioNTech's vaccine for those aged 16 and older on Monday. The two-dose immunization was the first to receive emergency use authorization from federal regulators in December 2020 and will now be first to be licensed. 'We're going to move forward making that vaccine mandatory, we're preparing the guidance for the force right now,' Kirby said in a news briefing Monday Now that Pfizer has received full FDA approval, Pentagon Press Sec. John Kirby says, "We're gonna move forward making that vaccine mandatory" for U.S. service members. pic.twitter.com/5IbJ68wesk— The Recount (@therecount) August 23, 2021 RELATED ARTICLES Previous 1 Next Get vaccinated or get fired! Mayor Bill de Blasio to... 'Long Covid'...
    DENVER (AP) — When the delta variant started spreading, Gina Welch decided not to take any chances: She got a third, booster dose of the COVID-19 vaccine by going to a clinic and telling them it was her first shot. The U.S. government has not approved booster shots against the virus, saying it has yet to see evidence they are necessary. But Welch and an untold number of other Americans have managed to get them by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated. Welch, a graduate student from Maine who is studying chemical engineering, said she has kept tabs on scientific studies about COVID-19 and follows several virologists and epidemiologists on social media who have advocated for boosters. “I’m going to follow these experts and I’m going to go protect myself,” said Welch, a 26-year-old with asthma and a liver condition. “I’m not going to wait another six months to a year for them to recommend a third dose.” While Pfizer has said it plans to seek U.S. Food and...
    Republican Ohio Gov. Mike DeWine signed legislation on Wednesday forbidding public schools and universities in the state from mandating any vaccination that lacks full Food and Drug Administration approval — covering all the COVID-19 vaccines, which have only gotten emergency approval. An amendment to H.B. 244, OK'd by DeWine, states public educational institutions are not permitted to discriminate "against an individual who has not received the vaccine, including by requiring the individual to engage in or refrain from engaging in activities or precautions that differ" from those who have received the jabs. However, the Ohio Department of Health can still demand quarantine for students and others who arrive at the state from different countries. NO EVIDENCE OHIO VACCINE LOTTERY INCREASED VACCINATION RATES, STUDY FINDS Vaccinations from Pfizer, Moderna, and Johnson & Johnson only received emergency use authorization and have yet to clear the final approval hurdle from the FDA. It is unclear when the government body will reach its determination, though President Joe Biden's chief medical adviser Anthony Fauci said he'd be "astounded" if each was not fully...
    PORTSMOUTH — Southern Ohio Medical Center is now offering the COVID-19 vaccine to individuals as young as 12, following the FDA’s decision to approve the Pfizer vaccine for the new age group. More than 250 million vaccines have been administered in the United States, and the data overwhelmingly shows that the shots are safe and effective. Adverse side effects are incredibly rare, and the Pfizer vaccine is more than 90% effective. The vaccine has also shown to be effective against some of the more worrying variants of the virus. Pfizer also recently applied for full FDA approval of their COVID vaccine. The company has requested priority review, which means it could receive full approval within the next six months. Nearly one-in-three Scioto County residents have received at least the first dose of a COVID vaccine. Statewide, more than 40% have begun the vaccination process. Eleven states have already vaccinated more than half of their total population. The benchmark for herd immunity, which is when enough people are resistant to a disease that it becomes much harder to spread, is generally...
    United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.  The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said Thursday. It’s the second FDA approval for Tyvaso, for which the Silver Spring biotech first received approval to help increase exercise ability in PAH patients in 2009.   Interstitial lunch disease is a group of diseases which cause scarring on the lungs. Prior to approval, United Therapeutics conducted a study of 326 patients with interstitial lung disease-associated pulmonary hypertension, which resulted in people showing improvement in their six-minute walk distance, according to a press… Read the full story from the Washington Business Journal.
    Rhizen Pharmaceuticals AG announces that its product, thresholdisib (UKONIQ ™), has received accelerated approval from the US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma
    The Food and Drug Administration (FDA) announced the first-ever approval of an Ebola drug, which is made of three monoclonal antibodies. The drug, Inmazeb, was developed by Regeneron Pharmaceuticals and is approved for use in both adult and pediatric patients diagnosed with the Zaire Ebola virus. The drug works by targeting the glycoprotein, which attaches to the cell receptor and allows for the virus to enter the cell. The antibodies used in Inmazeb bind to the glycoprotein and block the attachment and entry of the virus into the cell, according to the FDA. REGENERON CO-FOUNDER ON ANTIBODY COCKTAIL TRUMP IS TAKING “Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats – both domestically and abroad – on the basis of science and data,” said FDA commissioner Stephen Hahn, M.D., in a news release posted Wednesday. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.” The drug received approval status after the PALM trial and an...
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