The Indian Panorama

Tag: -Pfizer

  • Moderna asks the F.D.A. for authorization for a second booster for all adults

    Moderna asks the F.D.A. for authorization for a second booster for all adults

    WASHINGTON, D.C. (TIP): Moderna said late Thursday, March 17,  that it asked the Food and Drug Administration for emergency authorization of a second booster of its coronavirus vaccine for all adults, a significantly broader request than Pfizer and BioNTech filed for their shot this week, says a New York Times report. The request is likely to intensify the latest round of an ongoing scientific debate over how long protection from the two most-used vaccines in the United States lasts in the face of new variants.

    On Tuesday, March 15,  Pfizer and its German partner, BioNTech, asked for emergency authorization for a second booster for those 65 and older. The firm’s request was based heavily on data from Israel, where such shots are authorized for a somewhat broader group. Federal health officials have said they are concerned about waning potency of the booster shot that was authorized for both Moderna and Pfizer in the fall. But although there are indications that regulators could move swiftly on Pfizer’s request, it is unclear how favorably they will view Moderna’s more sweeping application. Moderna said its request covered all adults so the Centers for Disease Control and Prevention and health care providers could determine the appropriate use of a second booster, including for those at higher risk of Covid-19 disease because of age or underlying medical conditions. About 48 percent of eligible American adults, or 93 million people, have gotten booster shots, according to the C.D.C. More than two-thirds of those 65 or older have gotten the extra shot. Moderna said its request was partly based on recent data on how well its vaccine protected against the Omicron variant in the United States and Israel.

    Outside scientists are sharply divided over whether another dose is necessary now, and if so, for whom. In an interview on Friday, Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine in Houston, said, “I’m a strong proponent of giving a second booster now.”

    He said the first booster shot had “made a huge difference” in bolstering protection against hospitalization and even infection from the Omicron variant. “It’s also clear that protection is waning now pretty quickly a few months after your third dose,” he said. “So, it’s short-lived. The hope is that a second booster would restore it.” But Dr. Jesse L. Goodman, a former chief scientist for the F.D.A., said: “While protection is waning against mild infections, without more information we do not yet know to what extent, if any, protection is waning against severe disease.” Nor it is clear, he said, “to what degree and for how long another booster might help.” Among the data the companies cited was a study released last month by the Centers for Disease Control and Prevention that found the effectiveness of Pfizer’s and Moderna’s vaccines against hospitalization dropped from 91 percent two months after a booster shot to 78 percent after four months. The study presented a broad snapshot; it did not break down hospitalizations by age, presence of underlying conditions or other factors.

    (Source: PTI)

  • Pfizer jabs protect 70% against hospitalization from omicron

    Pfizer jabs protect 70% against hospitalization from omicron

    A two-dose Pfizer/BioNTech vaccination provides just 33 per cent protection against infection by the omicron variant of the coronavirus, but 70 per cent protection against hospitalisation, according to a large-scale analysis in South Africa.

    The first large-scale analysis of vaccine effectiveness in the region where the new variant was discovered appears to support early indications that omicron is more easily transmissible and that the Pfizer shot isn’t as effective in protecting against infection as it was against the delta variant.

    Omicron poses a higher risk of reinfection. For individuals who have previously had Covid-19, the risk of reinfection with omicron is significantly higher than that of earlier variants.

    Risk of hospitalisation from omicron is lower. Hospital admissions among adults diagnosed with Covid-19 attributed to omicron is 29 per cent lower compared to the Covid-19 wave that South Africa experienced in mid-2020, after adjusting for vaccination status.

    The analysis was based on more than 211,000 positive Covid-19 test results, 41 per cent from adults who had received two doses of the Pfizer vaccine. About 78,000 of these positive Covid-19 test results between November 15 and December 7 were attributed to omicron infections.

    The study was carried out by Discovery Health, South Africa’s largest private health insurer, and the South African Medical Research Council.

    The study has been carried out in the weeks since omicron was first announced in November by scientists in South Africa and Botswana. The researchers emphasized that its findings are preliminary and not peer reviewed.

    The data are gathered from the first three weeks of South Africa’s omicron-driven wave and may change as time passes. South Africa is the first country to experience a surge in Covid-19 driven by the omicron variant.

    South Africa has experienced rapid community spread — concentrated in its most populous province, Gauteng — dominated by the omicron variant.

                    Source: AP

  • FDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11

    FDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11

    WASHINGTON D.C. (TIP): The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children.

    Before the vaccine becomes widely available, it will also need to be recommended by the Centers for Disease Control and Prevention. The decision on that recommendation is made after a meeting of an expert committee, the Advisory Committee on Immunization Practices, or ACIP. The CDC director must then approve ACIP’s recommendations. That committee is scheduled to meet on Nov. 2. “As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock, in a statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

    The Pfizer-BioNTech Covid vaccine for children 5 to 11 should be given as two doses three weeks apart, just like the version for older children and adults, but uses a lower 10-microgram dose, one-third the adult dose.

    The FDA’s decision, which was widely expected, follows the meeting of the FDA’s advisory panel earlier this week. That panel voted 17-to-0, with one abstention, that the vaccine should be authorized. The FDA and CDC are not bound by the votes of their advisory committees, but generally follow their advice.

    However, when recommending the authorization, FDA panel members expressed concerns about whether all children needed the vaccine, because the risk of complications from Covid infection in children is generally lower. They also discussed how to balance the risk of a rare side effect, an inflammation of the heart called myocarditis, with the number of Covid cases prevented. FDA modeling predicted that the number of hospitalizations from myocarditis would generally be fewer than the number of Covid hospitalizations prevented.

    Still, those concerns could still prove a topic of debate for the ACIP when it meets next week.

    The vaccine was not granted FDA approval, but instead an emergency use authorization. Emergency authorizations are used when the secretary of Health and Human Services has declared a public health emergency to more quickly clear the use of vaccines, treatments, and diagnostic tests. These authorizations lapse when the state of emergency ends. Pfizer’s vaccine was fully approved for those age 16 and older in August and was previously granted an emergency use authorization for use in adolescents ages 12 to 15.

    “The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We are confident in the safety, effectiveness and manufacturing data behind this authorization.”

    The Pfizer product is currently the only Covid vaccine authorized for use in people under the age of 18 in the U.S., though that could change soon. Moderna has filed an application to have its emergency authorization expanded to include youths 12 to 17 years of age; the FDA is expected to rule on the application soon.

    “This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Pfizer’s chair and CEO, said in a statement. “Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

    (Agencies)

  • Mixed AstraZeneca-Pfizer shot boosts Covid antibody level, says study

    Mixed AstraZeneca-Pfizer shot boosts Covid antibody level, says study

    Seoul (TIP): A mixed vaccination of first AstraZeneca and then a Pfizer COVID-19 shot boosted neutralising antibody levels by six times compared with two AstraZeneca doses, a study from South Korea showed.

    The study involved 499 medical workers — 100 receiving mixed doses, 200 taking two doses of the Pfizer/BioNTech shot and the remainder getting two AstraZeneca shots.

    All showed neutralising antibodies, which prevent the virus from entering cells and replicating, and the result of the mixed schedule of vaccines showed similar amounts of neutralising antibodies found from the group that received two Pfizer shots.

    A British study last month showed similar results — an AstraZeneca shot followed by Pfizer produced the best T-cell responses, and a higher antibody response than Pfizer followed by AstraZeneca.

    The data provides further support for the decision of several countries to offer alternatives to AstraZeneca as a second shot after the vaccine was linked to rare blood clots.

    The South Korean study also analysed neutralising activity against major variants of concern, the Korea Disease Control and Prevention Agency (KDCA) said.

    None of the groups demonstrated reduced neutralising activity against the Alpha variant, first identified in Britain, but the neutralisation titre decreased by 2.5 to 6 fold against Beta, Gamma and Delta, first detected in South Africa, Brazil and India, respectively.