Health
The second MMR vaccine seeks FDA approval — precision vaccination
.jpg "The second MMR vaccine seeks FDA approval — precision vaccination")
GlaxoSmithKline based in Pennsylvania (GSKToday, we submitted a Biopharmacy Approval Application (BLA) for the Priorix vaccine to the U.S. Food and Drug Administration (FDA) seeking approval for use in active immunization against infections caused by measles, mumps, and rubella (MMR). I announced that I am.
If approved, Priorrix vaccine Providing alternative MMR vaccines to US-based healthcare providers. Merck, Inc. MMR® II is the major vaccine.
GSK said in a press release that it also seeks approval for Priorix as a second dose to individuals who have been vaccinated with another MMR vaccine.
The Priorix MMR vaccine, developed by GSK, was first registered in Germany in 1997 and is currently licensed in more than 100 countries around the world, with more than 400 million doses to date.
“If approved (BLA), Priorix will strengthen GSK’s long-term commitment to increasing the number of vaccines provided by GSK for pediatric diseases in the US market and prioritizing US public health,” said SVP. Judy Stewart, US Director, commented. Vaccine at GSK in the press statement issued August 2, 2021.
Priorix Freeze-dried mixture Preparation of attenuated Schwartz measles, RIT 4385 mumps (derived from Geryllin strain), and Wistar RA27 / 3 rubella virus strain. The measles and mumps components of the vaccine are produced in chicken germ cell cultures and may contain trace amounts of egg protein.
The safety of PRIORIX was evaluated in six clinical trials in which a total of 17,393 subjects received at least one dose of either Priorix or Merck’s MMR® II. The effectiveness of Priorix was demonstrated based on comparative data on immunogenicity with MMR® II.
The most commonly reported side effects were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever.
Children with the US CDC need to be vaccinated twice with the MMR vaccine. The first vaccination is 12 to 15 months old and the second vaccination is 4 to 6 years old. Teens and adults also need to be up-to-date on MMR vaccination.
Measles, mumps and rubella are acute and highly contagious viral diseases that cause significant morbidity and mortality worldwide. In recent years, outbreaks have occurred in the United States and around the world, with more than 400,000 cases confirmed in 2019, the CDC reports.
The majority of measles cases in 2019 were associated with under-vaccinated international travelers.
Also, in May 2020, about 80 million Children around the world were estimated to be inadequately vaccinated against measles and other illnesses.
Recently, CDC Reported good news. As of July 9, 2021, only two cases of measles were identified in the United States in 2021.
When the study Published in October 2019, definitive evidence that measles virus infection can destroy important immune cells that “remember” previous encounters with certain bacteria. .. This is because a weakened immune system can make about 40% of children who recover from measles infection vulnerable to other pathogens that may have been protected before the measles attack. Means that.
GSK is a science-led global health care company with the special purpose of helping people do more, feel better and live longer. For more information, please visit: www.gsk.com/about-us..
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Sources 2/ https://www.precisionvaccinations.com/2021/08/02/second-mmr-vaccine-seeks-fda-approval The mention sources can contact us to remove/changing this article |
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