Peter Marks News

Updated COVID-19 vaccines are on their way

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Dr. Peter Marks sent a letter to Acting FDA Commissioner Sara Brenner on Friday saying that he would resign and retire by April 5 as director of the Center for Biologics Evaluation and Research. In his letter, obtained by The Associated Press, Marks said he was “willing to work” to address the concerns expressed by Robert F. Kennedy Jr. about the safety of vaccinations. But he concluded that wasn’t possible. “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” he wrote. ALSO READ: Double trouble for Pete Hegseth? US Defense Secretary under fire for another controversy amid chat leak row

Government advisers say it’s time to update the recipe for the COVID-19 vaccines Americans will receive in the fall

The U.S. Food and Drug Administration (USFDA) on Thursday approved Adzynma, the first recombinant (genetically engineered) protein product indicated for on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder. The FDA granted approval of Adzynma to Takeda Pharmaceuticals U.S.A. Inc.

chikungunya, a virus spread by infected mosquitoes that the Food and Drug Administration called «an emerging global health threat.» The vaccine, developed by Europe's Valneva which will be marketed under the name Ixchiq, was approved for people 18 and over who are at increased risk of exposure, the FDA said. Ixchiq's green-light by the US drug regulator is expected to speed the vaccine's rollout in countries where the virus is most prevalent. Chikungunya, which causes fever and severe joint pain, is generally seen in tropical and subtropical regions of Africa, southeast Asia and parts of the Americas. «However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease,» the FDA said, reporting more than five million cases in the past 15 years. «Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,» senior FDA official Peter Marks said in a statement. «Today's approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.» Symptoms can sometimes last for months or even years, but the virus is rarely fatal.

Pfizer/BioNTech and Moderna that target a recently circulating Omicron variant of the coronavirus, according to a report published by the news agency Reuters. A third shot, made by Novavax, is still under review by the US FDA. However, Novavax did not expect its shot to be authorized in the United States before a meeting of a Centers for Disease Control and Prevention (CDC) advisory panel on Tuesday.

U.S. regulators have approved updated COVID-19 vaccines from Pfizer and Moderna, shots aimed at revving up protection this fall and winter

Respiratory Syncytial Virus (RSV) in their babies. The Pfizer shot, which was already approved for use in older adults, has now been greenlighted for use as a single injection from 32 through 36 weeks of pregnancy, to protect infants from birth through six months, a statement by the Food and Drug Administration said. It is the latest in a succession of medicines recently approved against the common microbe, which causes tens of thousands of hospitalizations among infants and the elderly in the United States every year, according to official estimates. Researchers have targeted an RSV vaccine since the 1960s, but the spate of shots that are emerging now were made possible thanks to a scientific breakthrough a decade ago. «RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,» said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. «This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.» The approval follows a clinical trial involving some 7,000 pregnant women, which showed Pfizer's vaccine, called Abrysvo, reduced severe disease caused by RSV by 82 percent in babies from 0-3 months, and 69 percent from 0-6 months. Abrysvo was previously approved by the FDA for adults aged 60 and over, as was another vaccine by drugmaker GSK, called Arexvy. While RSV most often causes mild, cold-like symptoms in infants and young children, it can also lead to more serious outcomes such as pneumonia and bronchiolitis. An estimated 58,000-80,000 children younger than five years are hospitalized due to RSV infection, according to