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U.S. CDC Still Looking at Potential Stroke Risk From Pfizer Bivalent COVID Shot
New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday. U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.
The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy.
Dr. Nicola Klein of healthcare company Kaiser Permanente, which maintains Vaccine Safety Datalink (VSD) data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.
Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said. FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time.
FDA Experts Are Still Puzzled Over Who Should Get Which COVID Shots and When
At a meeting to simplify the nation’s COVID vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has contributed to widespread skepticism, under vaccination and ultimately unnecessary deaths from COVID-19.
The committee voted unanimously Thursday to support the FDA’s proposal for all vaccine makers to adopt the same strain of the virus when making changes in their vaccines and suggested they might meet in May or June to select a strain for the vaccines that would be rolled out this fall.
However, the panel members disagreed with the FDA’s proposal that everyone get at least one shot a year, saying more information was needed to make such a declaration. Several panelists noted that in recent studies, only about a third of people hospitalized with a positive COVID test actually were there because of COVID illness. That’s because everyone entering a hospital is tested for COVID, so deaths of patients with incidental infections are counted as COVID deaths even when it isn’t the cause.
“We need the CDC to tell us exactly who is getting hospitalized and dying of this virus — the ages, vulnerability, the type of immune compromise and whether they were treated with antivirals. And we need immunological data to indicate who’s at risk,” said Dr. Paul Offit, director of the Vaccine Education Center and a pediatrician at Children’s Hospital of Philadelphia. “Only then can we decide who gets vaccinated with what and when.”
FDA Quietly Changes End Date for Study of Heart Inflammation After Pfizer COVID Vaccination
The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public.
Pfizer was supposed to complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine. The completion date was listed by the FDA in 2021 as June 20, 2022. Pfizer was also supposed to submit the results of the study to the FDA by the end of 2022 as part of a list of requirements the FDA imposed as a condition of approving Pfizer’s jab.
But after the deadline passed, the FDA quietly changed the date. Under a list of postmarketing requirements for the Pfizer-BioNTech vaccine, the FDA now says the same study has an “original projected completion date” of June 30, 2023. The current status of the study is listed as “pending.”
The study is one of nine Pfizer was to complete to examine post-vaccination adverse events. The study is designed to “prospectively assess the incidence of subclinical myocarditis” after receipt of a third dose, or a booster, in people aged 16 to 30.
Rubio Sends Letter Demanding Answers From Pfizer Over Project Veritas Video
Sen. Marco Rubio (R-FL) sent a letter to Pfizer this week demanding answers after an undercover sting video was published by Project Veritas this week that allegedly showed an official at the company claiming that it was involved in controversial research related to vaccines.
The 10-minute video, which has been viewed nearly 20 million times, shows a man identified as Jordon Trishton Walker, Pfizer’s director of research and development, strategic operations-mRNA scientific planner, claiming that the company is “exploring” ways to “mutate” coronaviruses so they can “create — preemptively develop new vaccines.”
Rubio responded to the video by sending a letter to Dr. Albert Bourla, chief executive officer and chairman of Pfizer Inc.
“I write in response to troubling reports on Pfizer’s intention to mutate the SARS-CoV-2 (COVID) virus through gain-of-function, or ‘directed evolution,’ as detailed by Pfizer Director of Research and Development, Jordan Walker,” Rubio said in his letter. “As has been proven time and time again, attempts to mutate a virus, particularly one as potent as COVID, are dangerous. If the claims detailed in the video are true, Pfizer has put its desire for profit over the concern of national and global health and must hold itself accountable.”
Omicron Sub-Variant XBB.1.5 Accounts for 61.3% of U.S. COVID Cases — CDC
The Omicron subvariant XBB.1.5 has likely become the dominant variant in the United States, accounting for 61.3% of COVID cases in the week ended Jan. 28, data from the U.S. Centers for Disease Control and Prevention showed on Friday.
XBB.1.5, which is currently the most transmissible variant, is an offshoot of XBB, first detected in October. The now-dominant XBB-related subvariants are derived from the BA.2 version of Omicron.
The Flu-ification of COVID Policy Is Almost Complete
For all the legwork that public-health experts have done over the past few years to quash comparisons between COVID-19 and the flu, there sure seems to be a lot of effort nowadays to equate the two. In an advisory meeting, the FDA signaled its intention to start doling out COVID vaccines just like flu shots: once a year in autumn, for just about everyone, ad infinitum.
Whatever the brand, primary-series shots and boosters (which might no longer be called “boosters”) will guard against the same variants, making them interchangeable. Doses will no longer be counted numerically. “This will be a fundamental transition,” says Jason Schwartz, a vaccine policy expert at Yale — the biggest change to the COVID-vaccination regimen since it debuted.
Hints of the annual approach have been dropping, not so subtly, for years. Even in the spring of 2021, Pfizer’s CEO was floating the idea of yearly shots; Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, teased it throughout 2022.
This past September, Joe Biden officially endorsed it as “a new phase in our COVID-19 response,” and Ashish Jha, the White House’s COVID czar, memorably highlighted the convenience of combining a flu shot and a COVID shot into a single appointment: “I really believe this is why God gave us two arms.”
South Dakota Senate Suspends Lawmaker After Vaccine Exchange
The South Dakota Senate on Thursday suspended a Republican state senator in a rare move that stripped the lawmaker of all legislative power while keeping the allegations against her a secret.
Sen. Julie Frye-Mueller, who is among a group of right-wing Statehouse Republicans, told reporters earlier Thursday that she was being punished following an exchange she had with a legislative aide about vaccinations.
Sen. Michael Rohl, the Republican lawmaker who initiated the motion to suspend Frye-Mueller, said in a statement that it was based on “serious allegations” and had been made to ensure the Legislature was creating a safe work environment for employees. He likened the Senate’s suspension to the move a business owner or human resources department would make when allegations are raised.
The Republican-controlled Senate voted 27-6 to form a committee to investigate Frye-Mueller’s conduct and in the meantime suspend her from voting or holding other rights of an elected official. Republican legislative leaders refused to comment Thursday on the allegations that led to them suspending the Senate rules and stripping their colleague of her ability to represent her constituents.
Exclusive: EU May Pay More for Pfizer COVID Shots in Return for Lower Volume
Brussels is discussing with Pfizer (PFE.N) and BioNTech (22UAy.DE) the possibility of reducing the up to 500 million COVID-19 vaccine doses the EU has committed to buy this year in return for a higher price, a source with knowledge of the talks said.
Also on the table is an extension of the deadline for delivery, possibly to the second half of 2024, the source said. They declined to be identified because the talks are confidential.
The negotiations are ongoing, and it is not clear what the final outcome may be. The talks come amid a global glut of COVID-19 shots and relate to the biggest contract for vaccines of all those signed by the EU while the pandemic raged.
