Pfizer gets some bad news and some good news

No company has profited more from the pandemic

BAD NEWS

Thailand study of young adults post jab showed nearly 30% with cardiovascular injuries

Abstract

This study focuses on cardiovascular effects, particularly myocarditis and pericarditis events, after BNT162b2 mRNA COVID-19 vaccine injection in Thai adolescents. This prospective cohort study enrolled students from two schools aged 13–18 years who received the second dose of the BNT162b2 mRNA COVID-19 vaccine. Data including demographics, symptoms, vital signs, ECG, echocardiography and cardiac enzymes were collected at baseline, Day 3, Day 7, and Day 14 (optional) using case record forms.We enrolled 314 participants; of these, 13 participants were lost to follow up, leaving 301 participants for analysis. The most common cardiovascular effects were tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%), and hypertension (3.99%). Seven participants (2.33%) exhibited at least one elevated cardiac biomarker or positive lab assessments. Cardiovascular effects were found in 29.24% of patients, ranging from tachycardia, palpitation, and myopericarditis. Myopericarditis was confirmed in one patient after vaccination. Two patients had suspected pericarditis and four patients had suspected subclinical myocarditis. Conclusion: Cardiovascular effects in adolescents after [Pfizer] mRNA COVID-19 vaccination included tachycardia, palpitation, and myocarditis. The clinical presentation of myopericarditis after vaccination was usually mild, with all cases fully recovering within 14 days. Hence, adolescents receiving mRNA vaccines should be monitored for side effects.

GOOD NEWS (for Pfizer)

On its own initiative FDA issued permission for pharmacists to prescribe the Pfizer COVID therapeutic drug Paxlovid.

Just another way for the company to even more money.

MedPage Today wrote about this unusual action.

“Licensed pharmacists can now prescribe nirmatrelvir-ritonavir (Paxlovid) for COVID-19 patients at high risk of progressing to severe disease (though with some limitations), the FDA announced on Wednesday.

"Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19," Patrizia Cavazzoni, MD, director of the agency's Center for Drug Evaluation and Research, said in a statement.

FDA noted that patients should still aim to talk to their regular healthcare provider first, or locate an authorized test-to-treat site. But if those options are unavailable, state-licensed pharmacists can now prescribe the highly effective antiviral as well.

Limitations outlined in the revised emergency use authorization (EUA) state that pharmacists should refer patients to a primary care provider for evaluation if insufficient information is available for assessing kidney function, liver function, or for potential drug interactions, and also if potential drug interactions might require medication changes.

The agency is advising patients to bring in their medical records from the past year, including recent blood work, so pharmacists can evaluate potential kidney or liver problems, as well as a list of the medications they currently take, so pharmacists can screen for possibly serious drug interactions with nirmatrelvir-ritonavir.

The scope of the revised EUA appears aimed at allaying concerns from the American Medical Association (AMA), among others, following the launch of the Biden administration's test-to-treat initiative. When the program was launched in March, the AMA warned against the pharmacist component of the plan, in particular saying in a statement that it "flaunts patient safety and risks significant negative health outcomes."

Though well intentioned, the AMA noted at the time that it "oversimplifies challenging prescribing decisions," not least of which include the drug's multiple pages of drug interactions that may call for reducing, pausing, or changing any number of medications. [emphasis added]

On Wednesday, the organization took another swipe at the idea, saying the requirements for prescribing nirmatrelvir-ritonavir extend "far beyond a pharmacist's scope and training."

"Patients will get the best, most comprehensive care from physician-led teams -- teams that include pharmacists," AMA President Jack Resneck, Jr., MD, said in a statement. "But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient's medical history and the ability to follow up."

The National Community Pharmacists Association welcomed the move, with CEO B. Douglas Hoey, RPh, MBA, calling pharmacists "the drug therapy and drug interaction experts," but Hoey also raised issues about payment.

"We're grateful to the FDA for engaging with us on this issue and appreciate the agency's course correction," he said in a statement. "The Biden administration and payers also must ensure appropriate payment for the pharmacist assessing the patients, performing drug and disease interaction checks, and working with physician colleagues on proper prescribing."

Nirmatrelvir-ritonavir is authorized for adults and kids ages 12 and up who test positive for SARS-CoV-2 (on rapid at-home antigen tests or on a PCR test) and are at high risk for progression to severe illness.

In clinical trials, the drug was shown to reduce the risk of hospitalization or death from COVID-19 by 89% in these patients. It has failed to show significant benefit in trials involving standard-risk patients, including those vaccinated against COVID-19.”

Another piece of news

The CEO of Pfizer after four shots/boosters tested positive for COVID.

He is now taking Paxlovid.

Never too late to read the best book on the pandemic.