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Moderna and Novavax Respond to Trump’s Demands for COVID Vaccine Evidence
Pharmaceutical Executive reported:
Moderna and Novavax issued responses to President Trump’s demands for information about the COVID-19 vaccines. The two pharma companies are joining Pfizer, who issued a response earlier this week. On Labor Day, President Trump posted a message on his Truth Social page demanding that the COVID-19 vaccine makers “justify the success” of the vaccines. The tone of the message caused confusion, as it appeared to be both accusing and praising the drug companies at the same time.
The President’s post reads, “Many people think (the COVID vaccines) are a miracle that saved millions of lives. Others disagree! With CDC being ripped apart over this question, I want the answer, and I want it NOW. I have been shown information from Pfizer, and others, that is extraordinary, but they never seem to show those results to the public.”
In a post on its own website, Moderna reaffirmed its commitment to transparency and says that it welcomes the opportunity to share its collected research about the impact of its COVID-19 vaccines. According to the company, this research has already been publicly published in “hundreds” of peer-reviewed journals which that regulators have access to.
Pfizer Defends Covid Shot, Says Trump Deserves Nobel Prize
Pfizer Inc. defended the research supporting its COVID-19 vaccine in a statement on its website, in a direct response to a social media post by President Donald Trump over the weekend questioning whether drug companies were withholding information about the shots.
The company is “dedicated to continuing to provide clear, factual data to the public,” Pfizer Chief Executive Officer Albert Bourla said in the statement, adding that data on Pfizer’s COVID-19 shot has been disclosed in more than 600 peer-reviewed publications.
Bourla also praised Trump’s handling of Operation Warp Speed, which shepherded the development of COVID-19 vaccines, saying the effort “would typically be worthy of the Nobel Peace Prize, given its significant impact.”
Pennsylvania Pharmacies Can Now Offer New COVID Vaccines After State Adopts Recommendations From Medical Societies
Pennsylvania pharmacists can now offer new COVID-19 vaccines to eligible people without fear of legal repercussions or violating state vaccination laws. The state will recognize vaccine recommendations from major medical organizations like the American Academy of Pediatrics in addition to other professional medical groups in the absence of federal guidance from the Centers for Disease Control and Prevention.
Pennsylvania is the latest state to adopt vaccine counsel from nongovernmental agencies in order to ensure access to COVID-19 shots this fall as health leaders with the Trump administration move to restrict or limit eligibility.
Conflicting information on vaccination rules this year has caused confusion for both patients and health providers, said pharmacist Mitchel Rothholz, a consultant and member of the Pennsylvania Pharmacists Association. “Their focus is serving the patients, and they don’t want to do something wrong,” he said.
Common Heart Attack Drug Doesn’t Work and May Raise Risk of Death for Some Women, New Studies Say
A class of drugs called beta-blockers — used for decades as a first-line treatment after a heart attack — doesn’t benefit the vast majority of patients and may contribute to a higher risk of hospitalization and death in some women but not in men, according to groundbreaking new research.
“These findings will reshape all international clinical guidelines on the use of beta-blockers in men and women and should spark a long-needed, sex-specific approach to treatment for cardiovascular disease,” said senior study author Dr. Valentin Fuster, president of Mount Sinai Fuster Heart Hospital in New York City and general director of the National Center for Cardiovascular Investigation in Madrid.
Women with little heart damage after their heart attacks who were treated with beta-blockers were significantly more likely to have another heart attack or be hospitalized for heart failure — and nearly three times more likely to die — compared with women not given the drug, according to a study published in the European Heart Journal and also scheduled to be presented Saturday at the European Society of Cardiology Congress in Madrid.
US Insurers Likely to Cover Updated COVID Shots This Year, Industry Sources Say
Broad U.S. health insurance coverage of the COVID-19 vaccine is not likely to change this fall even after the U.S. Food and Drug Administration limited the shot to people 65 and older or those with health conditions, sources at two insurance trade organizations said.
Coverage could change starting in January 2026 when health plans offer new annual benefits and depending on the type of recommendations made in the coming months by the Centers for Disease Control and Prevention’s outside committee of advisers, they added.
U.S. insurers currently provide broad coverage at no cost for the initial shots and annual COVID-19 boosters based on recommendations from that committee, known as the Advisory Committee on Immunization Practices, as required by the Affordable Care Act.
HHS Says New Rule Will Improve Prescription Drug Price Transparency, Prior Authorization
A new rule from the U.S. Department of Health and Human Services (HHS) set to go into effect on Oct. 1 will allow health care providers and patients to determine the drug prices for prescription drugs and potential alternatives based on a patient’s insurance plan. In addition, providers will be able to submit prior authorizations — requests to cover more expensive medications or medical procedures — electronically, speeding up those decisions.
The drug price transparency tool addresses “affordability issues at the time that a product is prescribed, by comparing the patient-specific cost of a product to the cost of a suitable alternative and comparing prescription costs at different pharmacies,” according to HHS background slides on the HTI-4 Final Rule.
The document also states that electronic prior authorization “addresses processes that have contributed significantly to patient and provider burden, for instance, delays experienced by patients and clinicians as they seek to satisfy the requirements associated with prior authorization rules set by payers.”
In June, the U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare & Medicaid Services Administrator Mehmet Oz met with health insurance executives to discuss changes to prior authorization policies.
