FDA authorizes Pfizer COVID-19 vaccine for children ages 5 to 11
Fox News medical contributor Dr. Marty Makary voices concern about potential vaccine mandates for kids
The United States government announced plans to purchase sotrovimab, an investigational monoclonal antibody used for the early treatment of COVID-19, according to a press release from the drugmakers, GlaxoSmithKline (GSK) plc and Vir Biotechnology, Inc. The contracts total approximately one billion dollars, according to the news release.
“Given the large number of patients who continue to become ill with COVID-19 across many regions in the US, there is an ongoing need for access to effective treatments. We are proud to work with the US government to help make sotrovimab available for these patients.”, Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said in a news release.
Nurse Mary Ezzat prepares to administer a Pfizer COVID-19 booster shot to Jessica M., Thursday, Aug. 19, 2021, at UCI Medical Center in Orange, Calif. Jessica M. is a healthcare worker who is also immunocompromised. California Gov. Gavin Newsom, along with Colorado Gov. Jared Polis and New Mexico Gov. Michelle Lujan Grisham have taken steps to expand the use of booster shots to quell the recent surge in COVID-19 infections. (Jeff Gritchen/The Orange County Register via AP)
(Jeff Gritchen/The Orange County Register via AP)
Sotrovimab was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in May 2021. Under the EUA, the investigational single-dose intravenous infusion SARS-CoV-2 monoclonal antibody can be used to treat mild-to-moderate COVID-19 in adults and children 12 years of age and older, who tested positive for COVID-19, and are at high risk for developing severe cases of COVID-19 leading to hospitalization or death, according to the FDA website.
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“It gives patients a real heads start in fighting off the virus,” Bart Murray, Vice President of COVID Therapeutics at GSK told Fox news in an interview.
Murray told Fox news that patients who test positive for Covid-19 need to be aware of this treatment and should ask their doctors if it is appropriate for them, especially if they have an underlying condition or are immunocompromised.
“People need to know there are highly effective treatments for patients at high risk – and shouldn’t hesitate to ask their doctor to get treated,” Murray told Fox.
Sotrovimab is not authorized for use in every case. According to the FDA website, sotrovimab is not authorized for those hospitalized due to COVID-19, or require oxygen therapy due to COVID-19. It is also not indicated in patients who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity), the health agency stated on the website. The FDA also says SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when given to patients hospitalized with COVID-19 requiring high flow oxygen or mechanical ventilation.
Final data released from the COMET-ICE Phase III trial involving 1057 participants , showed sotrovimab reduced hospitalization and risk of death by 79 percent in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease at day 29 compared to placebo, according to a news release by the companies.
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The release noted that in vitro data suggested sotrovimab maintains activity against the Delta variant and other variants being monitored.
Linda Busby, 74, receives a vaccination card after receiving a shot of the Johnson &amp; Johnson COVID-19 vaccine at the Aaron E. Henry Community Health Service Center, Wednesday, April 7, 2021, in Clarksdale, Miss. Busby joined a group of seniors from the Rev. S.L.A. Jones Activity Center for the Elderly that were given a ride to the health center for their vaccinations. The Mississippi Department of Human Services is in the initial stages of teaming up with community senior services statewide to help older residents get vaccinated. (AP Photo/Rogelio V. Solis)
The companies also announced that data from the COMET-Tail Phase III study suggested that injecting Sotrovimab into the patient’s muscle was similarly effective compared to administering it intravenously in high-risk populations.
Barron said this potentially offers a more convenient option for patients suffering from Covid-19, according to the release.
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GSK officials told Fox News they will supply these doses to the US government by December 17, 2021, expanding nationwide access to sotrovimab for patients. “With the expected winter surge months ahead of us, the supply is timely”, Murray told Fox news interview.
Murray explained during the interview that the treatment is free for those who are eligible for the therapy, thanks to the government contract.
“It’s important to get the vaccine – but if you still get the virus you still have the option to get the antibodies at no cost.”