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    Alexandria Hein

    Pfizer seeks UK approval for COVID-19 vaccine in teens

    Pfizer has asked U.K. regulators to authorize its COVID-19 vaccine for teens ages 12 to 15 following the FDA’s decision to do so earlier this week. A spokesperson told Fox News that the company submitted data to the Medicines and Healthcare products Regulatory Agency (MHRA) for review.

    It was not clear when the MHRA would issue a decision, or how quickly shots would be made available to teens if authorized.  

    “We cannot speculate on the timing of the MHRA’s decision,” a Pfizer spokesperson said.

    ENGLAND REPORTS ZERO DAILY COVID-19 DEATHS FOR FIRST TIME SINCE JULY

    Currently, the NHS is only offering COVID-19 vaccines to people aged 40 and older, those at high risk, people who live or work in care homes, health and social care workers, people with learning disabilities and those who are a main caregiver for someone at high-risk. Eligibility will be expanded to all adults over 20 by the end of July.

    The U.K. has given out over 53.6 million doses of COVID-19 vaccines, with efforts hitting an all-time high in mid-March and recently averaging around 482,000 shots a day.

    In the U.S., the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is meeting Wednesday to discuss recommendations regarding the Pfizer-BioNTech vaccine in teens ages 12-15. However, several states jumped out ahead of the committee’s recommendations to begin offering the vaccines to teens following the FDA’s decision.

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    Prior to authorized use in 12 to 15-year-olds, the shot had been authorized for use in people ages 16 and older. Trials involving children under 12, including infants, are ongoing. The company has also initiated the process to acquire full FDA approval.

    About 20 cases of Indian coronavirus variant detected in France

    France’s health minister told a news outlet Monday that the Indian coronavirus variant has been detected in about 20 people thus far. Cases of the variant, identified as B.1.617, were first detected in France at the end of April, with the illnesses detected in three people who had recently traveled from India, France24.com reported.

    The United States considers the strain from India to be a “variant of interest (VOI),” which differs from a “variant of concern (VOC).” According to the Centers for Disease Control and Prevention (CDC), a VOI has been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, reduced efficacy of treatments, potential diagnostic impact or predicted increase in transmissibility or disease severity.

    There are four versions of the variant detected in India considered to be of interest by the CDC, including B.1.617, B.1.617.1, B.1.617.2 and B.1.617.3. Officials are watching for the variants’ impact on reduced neutralization by antibody treatments, and impact on vaccine efficacy. The World Health Organization (WHO) also considers the strain to be a variant of interest.

    France’s health minister, Olivier Veran, reportedly told France Info radio that it was not clear if the currently authorized vaccines were effective against the Indian variant.

    COVID-19 VACCINE DESERTS: SOME COUNTRIES HAVE NO SHOTS AT ALL

    India is currently facing a devastating surge in cases that have been blamed on emerging variants and lax public health measures surrounding mass political rallies and religious celebrations. Hospitals across the country have been overwhelmed by ill patients with many running out of necessary supplies like oxygen and personal protective equipment.

    May 6, 2021: A man receives a Pfizer COVID-19 vaccine at a new vaccination center run by the Paris’ fire brigade in Paris.
    (AP Photo/Michel Euler)

    Dr. Anthony Fauci, the White House chief medical advisor, told ABC this weekend that mass vaccination efforts would be key to ending the crisis in India. However, India, which was expected to be a large producer of the AstraZeneca vaccine, has focused its attention elsewhere as supplies run scant. The U.S. and other countries pledged to send production materials and unused doses to the country in an effort to bridge the gap.

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    “They’ve got to get their resources – not only from within but also from without – that’s the reason why other countries need to chip in to be able to get either supplies for the Indians to make their own vaccines or to get vaccines donated,” Fauci said.

    CDC received ‘handful’ of possible Johnson & Johnson COVID-19 vaccine adverse reports, Walensky says

    The Centers for Disease Control and Prevention (CDC) in conjunction with the Food and Drug Administration (FDA) is working through “a handful” of reports regarding possible adverse events related to the Johnson & Johnson COVID-19 vaccine that have been flagged since the rollout was paused last week.

    In the White House COVID-19 briefing on Monday, Dr. Rochelle Walensky said that the agency is working to determine whether the incidents do qualify as a case, and will present the new information to the Advisory Committee on Immunization Practices in a meeting on Friday. She said the reports were made through the Vaccine Adverse Event Reporting System (VAERS), and that she was encouraged by the low numbers.

    “These have been a handful of cases, not an overwhelming number of cases we are working through and adjudicating them and verifying whether they do in fact reflect a true case and that will be the work of the CDC this week as well as the FDA and then we will present that to the ACIP on Friday,” Walensky said. “We are doing that work right now – we are encouraged that it hasn’t been an overwhelming number of cases, but we are looking at seeing what’s come in.”

    COVID-19 VACCINE ELIGIBILITY EXPANDED TO ALL ADULTS UNDER PRESIDENT BIDEN’S DIRECTIVE

    The pause came after six incidents involving a rare, severe type of blood clot that occurred alongside low platelet counts were flagged in the nearly 7 million recipients who received the Johnson & Johnson one-shot COVID-19 vaccine.

    In a meeting held the next day, the ACIP was notified about a seventh case involving a woman who formed a clot but it did not occur in the brain, and another instance involving a male during clinical trials but it could not be tied to the shot at that time.

    Rather than issue updated guidance or recommendations regarding the vaccine, the ACIP decided to extend the pause in the rollout to allow for more time for people to report possible instances and collect more data. Critics said the extended pause would add to vaccine hesitancy and that the low number of instances suggested minimal risk to the greater population.

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    However, officials said the pause would allow for more time to reach health care providers to inform them how to treat the CVST clot, which calls for a different regimen than standard clots. Federal officials said they were working with states to facilitate rescheduling appointments for people who were due to receive the Johnson & Johnson vaccine.

    COVID-19 vaccine eligibility expanded to all adults under Biden’s directive

    Monday marked President Biden’s deadline for states to make COVID-19 vaccine supply available for all U.S. adults. The deadline came as health authorities reported that over half of adults had received at least one dose of the jab thus far.

    The Centers for Disease Control and Prevention (CDC) now reports that 50.4%, or 129.9 million, had received at least one dose of vaccine. For those ages 65 and older the percentage had climbed to over 81%.

    The milestone comes as federal authorities have sought to reassure the public that there is ample supply to vaccinate eligible adults despite a pause in the Johnson & Johnson COVID-19 vaccine rollout. The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet again to discuss safety and possible new guidance regarding the one-dose jab on Friday.

    HALF OF US ADULTS HAVE RECEIVED AT LEAST ONE COVID-19 SHOT

    Dr. Anthony Fauci, the nation’s top infectious disease expert, and U.S. Surgeon General Dr. Vivek Murthy said the pause shouldn’t cause Americans to turn away from vaccines, and should instead serve as a sign that safety protocols are working. The ACIP had previously been tasked with meeting over concerns about clotting among six recipients of the 7 million Johnson & Johnson recipients just one day after the CDC and FDA recommended a pause. 

    Several committee members expressed concern that there wasn’t enough time to issue any kind of recommendation or guidance, and that more data was needed to make a decision. 

    Last week, Andy Slavitt, the White House senior advisor on COVID-19 response, said federal officials were working with states to reschedule Johnson & Johnson appointments with either Moderna or Pfizer shots. He emphasized that mobile units that have been deployed as part of vaccine outreach are equipped to travel and distribute all three products.

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    Initially, Biden had set the date for all adults to become eligible for May 1, but as the pace of vaccinations quickened and supply became more readily available, he moved the deadline up by several weeks to April 19. A majority of states had acted to open eligiblity ahead of the deadline. Biden also doubled his administration’s goal to administer 100 million shots within in his first 100 days, to 200 million. According to CDC data, the U.S. has already administered over 209 million doses ahead of the April 28 marker.

    Inactivity increases risk of COVID-19 death, study suggests

    A recent study of nearly 50,000 coronavirus patients found that those who were consistently inactive were at greater risk of death due to the virus than those who engaged in exercise. The study, which relied on the “Exercise Vital Sign” measurement developed by Kaiser Permanente Southern California, found that even those who were active on an inconsistent basis were at lower odds for severe COVID-19 compared to those who were inactive.

    “This is a wake-up call for the importance of healthy lifestyles and especially physical activity,” Robert E. Sallis, M.D., a family and sports medicine physician at the Kaiser Permanente Fontana Medical Center, said, in a news release posted to EurekAlert.org. “Kaiser Permanente’s motivation is to keep people healthy, and this study truly shows how important that is during this pandemic and beyond. People who regularly exercise had the best chance of beating COVID-19, while people who were inactive did much worse.”

    Sallis said that walking at a moderate pace for 30 minutes daily could “give you a tremendous protective effect” against the virus.

    The study, published in the British Journal of Sports Medicine, focused on 48,449 adults diagnosed with COVID-19 between January 1, 2020 to October 21, 2020 who had at least two measures of their “Exercise Vital Signs” between March 2018 and March 2020. From the data, researchers found 6.4% of patients were consistently active, while 14.4% were consistently inactive.

    FDA CALL TO PAUSE JOHNSON & JOHNSON COVID-19 VACCINE ‘STRONG ARGUMENT FOR SAFETY,’ FAUCI SAYS

    Overall, 8.6% of the patients involved in the study wound up hospitalized, while 2.4% were admitted to the ICU and 1.6% died. However, the researchers found that being consistently inactive more than doubled the odds of hospitalization among this group, and that the risk of death was 2.49 times greater for these patients compared to those who were consistently active.

    HOW DOES JOHNSON & JOHNSON COVID-19 VACCINE COMPARE TO PFIZER, MODERNA? 

    Among all patients, those who were consistently inactive coupled with having a history of organ transplant and being over age 60 were at greatest risk of COVID-19 death.

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    “What surprised me most from this study was the strength of the association between inactivity and poor outcomes form COVID-19,” Deborah Rohm Young, Ph.D., a study co-author from Kaiser Permanente Southern California Department of Research & Evaluation, said in the news release. “Even after we included variables such as obesity and smoking in the analysis, we still saw inactivity was strongly associated with much higher odds of hospitalization, ICU admission, and death compared with moderate physical activity or any activity at all.”

    Allergic reactions to Pfizer, Moderna COVID-19 vaccines focus of new clinical trial

    The National Institutes of Health (NIH) has launched a clinical trial to better understand allergic reactions related to the Moderna and Pfizer- BioNTech COVID-19 vaccines. The trial, which will involve 3,400 adults, 60% of whom have a history of severe allergic reactions or a diagnosis of mast cell disorder, will also consider the biological mechanism behind the reactions to see if a genetic pattern or other factors can better predict who is at risk of a reaction.

    The participants will be split into two groups and be unaware as to if they are receiving a vaccine or placebo until after the second dose is administered and the observation period has concluded.

    The Centers for Disease Control and Prevention (CDC) first reported on the instances of anaphylaxis weeks after the initial rollout of the COVID-19 vaccines. In rare cases, some recipients experienced adverse reactions such as severe allergic reactions within minutes of the vaccine being administered. As such, the agency issued guidance recommending that those who experienced anaphylaxis after the first dose not get the second, and that vaccine providers be equipped with epinephrine, antihistamines, blood pressure monitors and timing devices to check a patient’s pulse.

    UK CORONAVIRUS VARIANT NOW ‘MOST COMMON LINEAGE’ IN US, WALENSKY SAYS

    “The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a news release. “The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the risks.”

    MOST CHILDREN WITH MIS-C EXPERIENCED ONLY MILD CORONAVIRUS SYMPTOMS PRIOR TO INFLAMMATORY ILLNESS: STUDY

    In the trial, researchers will collect blood, urine and nasal swabs from participants before the jab, and blood and urine after. The participants will also be monitored for at least 90 minutes after each injection. Researchers will analyze the proportion of study participants in each group who experienced a systemic allergic reaction within 90 minutes of either dose.

    “If a significant number of systemic allergic reactions to either or both vaccines occur during the trial, investigators will analyze these biological samples to examine possible mechanisms for the reactions and whether certain genetic patterns are associated with higher risk,” the news release said.

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    The researchers expect to have results by late summer.

    Wild songbirds behind multi-state salmonella outbreak, CDC says

    A salmonella outbreak linked to 19 illnesses including eight hospitalizations across eight states has been linked to wild songbirds, the Centers for Disease Control and Prevention (CDC) said Thursday. The agency’s investigation, which says illnesses date as far back as December 26, 2020, said the bacteria from sick people’s samples are closely related, and that it was also similar to the samples collected from sick or dead wild pine siskin birds.

    The agency also warned that the true number of illnesses is “likely much higher” as many people can recover from salmonella without medical care. The outbreak sickened people ages 2 months to 89 years, while patients had a median age of 16. Health officials said laboratory and epidemiologic data point to contact with the wild songbirds and with bird feeders is likely leading to the illnesses.

    The agency warns you can get sick when you touch your mouth with unwashed hands after touching birds, bird feeders or birdbaths.
    (iStock)

    As a result, the CDC is reminding people that birds can carry germs like salmonella while appearing healthy and clean. The germs can also spread between species of birds, to pets and to people.

    UK CORONAVIRUS VARIANT LIKELY CIRCULATED IN US UNDETECTED FOR MONTHS, RESEARCERS SAY

    “You can get sick when you touch your mouth with unwashed hands after touching wild birds, bird feeders or birdbaths, or your pets that have contact with wild birds,” the agency warned, adding that cleaning and disinfecting bird feeders and bird baths weekly or when they are visibly dirty can help keep you safe.

    The agency also warns against cleaning bird feeders in the kitchen or in places where food is prepared or stored. Keeping pets away from bird feeders and birdbaths and the areas under them can also help. In the event that you find a sick or dead bird in the yard, officials recommend removing the feeder and bath for at least two weeks and cleaning them outdoors.

    “Do not touch or hand-feed wild birds with your bare hands,” the agency said. “If you find a sick bird, call your state wildlife agency or wildlife rehabilitator.”

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    Salmonella can cause diarrhea and high fever and stomach cramps which will start around six hours to six days after swallowing the bacteria. While most people recover without treatment after four to seven days, some people, especially young children and older adults and those with weakened immune systems may have more severe illnesses that require treatment or hospitalization.

    WHO report on COVID-19 origin inconclusive, calls for further studies

    The World Health Organization (WHO) released its report on the origins of the coronavirus Tuesday, with the research team listing introduction through an intermediary host followed by zoonotic transmission as “likely to very likely” the root of initial spread, and introduction through a laboratory incident as “extremely unlikely.”

    In the introduction through an intermediary host followed by zoonotic transmission scenario, the SARS-CoV-2 virus is transmitted from an animal reservoir to an animal host, followed by subsequent spread within that intermediate host that then transmits it to humans.

    “SARS-CoV-2 adapts relatively rapidly in susceptible animals (such as mink,” the report stated. “The increasing number of animals shown to be susceptible to SARS-CoV-2 includes animals that are farmed in sufficient densities to allow potential for enzootic circulation.”

    The team called for more research into supply chains from wildlife farms and studies involving neighboring regions.

    UK VARIANT HUNTERS LEAD GLOBAL RACE TO STAY AHEAD OF COVID

    The review also considered two other scenarios for virus origin, including introduction through the cold/food chain, which researchers “considered possible,” and direct zoonotic transmission, which the team listed as “possible to likely.”

    Overall, without a definitive conclusion as to how the virus made its way into the human population, the team, which is comprised of international experts, called for “a continued scientific and collaborative approach to be taken towards tracing the origins of COVID-19.”  

    In a press conference held Tuesday following the release of the report, Dr. Thea Fisher said the investigation is the first step in a long journey into discovering the origins of the virus. She also acknowledged that it’s possible milder of cases of the virus may have been circulating before the outbreak in Wuhan was declared in December 2019.

    The early cases had been tied to the seafood market but the report could not definitively conclude whether it was the true origin of the virus.

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     “No firm conclusion therefore about the role of the Huanan market in the origin of the outbreak, or how the infection was introduced into the market, can currently be drawn,” the report said.

    The Associated Press had obtained a draft copy of the report on Monday ahead of its release. The report is based largely on a visit by a WHO team of international experts to Wuhan, the Chinese city where COVID-19 was first detected, from mid-January to mid-February.

    CanSinoBIO to develop inhaled COVID-19 vaccine, report says

    A team in China said it’s been given the green light to begin developing an inhaled version of its COVID-19 vaccine, Reuters reported. CanSinoBIO and the Beijing Institute of Biotechnology recently won emergency use approval in Hungary for its injectable vaccine, Convidecia.

    The recently issued EUA follows approval already given by Pakistan and Mexico.

    “We are pleased to see the authorization by the Hungarian authority for our vaccine, which marks an important step forward in the global fight against the COVID-19 pandemic,” Dr. Xuefeng YU, CanSinoBIO’s chairman and chief executive officer, said following Hungary’s EUA. “As CanSinoBIO continues to receive approvals from various governments across different continents, we are focusing on ramping up production capacity to deliver our one-shot vaccines quickly and safely to countries that are in desperate need of mass protection from this pandemic.”

    NEEDLE-FREE COVID-19 VACCINES IN THE WORKS, WHO SCIENTIST SAYS

    The company had not yet published a news release regarding the inhaled version of the vaccine. Previous trials involving the injectable product had shown 95.47% efficacy in preventing severe COVID-19 disease two weeks post-vaccination, according to the company.

    The next generation of COVID-19 vaccines currently in development includes needle-free options and those that can be stored at room temperature. 
    (iStock)

    Experts have surmised that the next generation of COVID-19 vaccine may include needle-free options, potentially helping to eliminate hesitancy among groups with sensitivity to needles.

    SINOVAC SAYS IT’S COVID-19 VACCINE IS SAFE FOR CHILDREN AS YOUNG AS 3

    According to Bloomberg News, the World Health Organization’s top scientist said as many as six to eight new vaccines may be ready for regulatory review by the end of this year, including ones that don’t require a needle and can be stored at room temperature.

    Soumya Swaminathan told the news outlet that several experimental candidates use alternative delivery systems, including more single shot jabs and those administered orally, via a nasal spray and even potentially through a skin patch.

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    “We need to continue to support the research and development of more vaccine candidates, especially as the need for ongoing booster immunization of populations is still not very clear at this point,” Swaminathan told Bloomberg News. “So we need to be prepared for that in the future.”

    Merck, Johnson & Johnson partner on COVID-19 vaccine manufacturing

    Merck & Co. is teaming up with rival Johnson & Johnson to help manufacture its recently-approved COVID-19 vaccine as the nation seeks to eliminate the virus in part through a mass inoculation effort. Two White House officials confirmed the partnership to Fox News.

    Johnson & Johnson previously agreed to supply the U.S. with 100 million doses of its one-shot vaccine by June, but White House officials said the company had struggled with supply and material issues.

    Last week, ahead of the FDA’s emergency use authorization, Jeff Zients, White House COVID-19 coordinator, had said the Biden administration was working to further “accelerate the pace and timeframe” for which the company delivered the agreed-upon supply after learning that Johnson & Johnson had fallen behind in their production schedule. 

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    President Joe Biden is expected to formally announce the partnership between rivals Merck and Johnson & Johnson later Tuesday.

    Fox News’ Peter Doocy contributed to this report.