The risks of getting a J&J shot: What you need to know

In weighing all their options on Friday, federal regulators made the decision to lift their suspension of the use of the one-shot Johnson & Johnson COVID-19 vaccine for a simple reason: It might just save your life.

That’s true even for women aged 18-49. So far, 13 of 15 reported cases of rare blood clotting and low platelets among J&J shot recipients have occurred among that demographic, and regulators believe that it is likely that the vaccine is associated with the condition. Three have died and seven have been hospitalized, with four in intensive care. The remaining five have been discharged.

Connecticut has resumed offering J&J to residents in addition to the Moderna and Pfizer/BioNTech vaccines that have been available to residents since the beginning of the year. With 136,000 J&J doses in reserve and a number of walk-up clinics opening in coming days, residents will have more ways to get the single-shot option.

But will they? Or will the “pause” have scared away people that could benefit from it the most?

“Oftentimes people kind of overread the relative risks,” said Josh Geballe, the state’s chief operating officer, at a press conference on Monday. “So there was a little bit of initial apprehension. I think it will take some time to see how that plays out.”

The Centers for Disease Control and Prevention and the Food and Drug Administration “have full confidence that this vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older,” FDA Acting Commissioner Janet Woodcock said during a press conference Friday night. The agencies chose not to limit the use of the vaccine by age or gender but to add a warning label for young women.

Here’s a walkthrough of the numbers behind the FDA’s decision — and what they mean. There are two parts to determining whether to take the J&J vaccine: Understanding the implications of making a decision, and understanding the implications of inaction in the face of the morbidity and mortality dangers posed by COVID-19.

What are the risks of getting the J&J vaccine?

Based on available data, the risk varies based on demographic characteristics. Reported cases have largely clustered by gender, although one man developed the condition in a Johnson & Johnson clinical trial. Among the 15 women, “the age ranged from 18 to 59, with a median age of 37,” said Rochelle Walensky, the director of the CDC during a press conference Friday night. These cases include the six that were initially reported; in addition, the CDC “broadened our case definition to make sure we were capturing all of the possible cases,” she said.

Part of the rationale behind the pause was also to help physicians understand how to treat the condition; the CDC specifically discouraged the use of heparin, a common blood thinner, when it put the pause into effect. “Of the additional cases that were reported to the CDC, none of them received heparin, likely improving their outcome and demonstrating that our systems worked,” Walensky said.

On Friday, the Advisory Committee on Immunization Practices discussed additional updates on the management of the condition, including recommending other anti-coagulants and cautioning against platelet infusion. Current guidance also recommends a course of treatment with immunoglobulins “that appears to reverse this process in, at least, a number of people who received it,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, during a press conference Friday night.

What are the benefits of getting the J&J vaccine for you?

While the risk of complications may vary by age and gender, the Johnson & Johnson vaccine has shown to be effective at preventing illness across demographic groups, FDA data show. In the J&J trials, efficacy was measured in the relative reduction of the risk of contracting COVID-19 and was found to be 72%.

The efficacy rate is widely misunderstood to mean that people still have a 30% chance of contracting COVID after vaccination with J&J. This would only be true if infection rates were so high that everyone without protection was guaranteed to get sick with COVID-19, which isn’t the case. The true risk of contracting the virus after vaccination is much lower, depending on present rates of community transmission. Whatever the present risk of getting infected, it would reduce by 72% on average post-J&J vaccination.

But these rates don’t take into account the most serious outcome of contracting COVID-19: death. In the clinical trial, none of the J&J recipients died; 16 in the placebo group did.

The data also show that 28 days after vaccination, none of the J&J recipients required medical intervention, which was defined separately from severe COVID. Five people in the placebo group did, however.

What are the consequences for you of not getting vaccinated at all?

If vaccination carries risks, the decision not to get vaccinated carries greater risks.

The CDC’s Advisory Panel on Immunization Practices considered the chances of being hospitalized and dying of COVID against any risk posed by the vaccine and concluded that the vaccine was beneficial on balance for individuals of all demographics under consideration.

What are your other options?

Connecticut continues to receive the Moderna and Pfizer vaccines, both of which use different biotechnology — based on mRNA — than the J&J, which is an adenovirus vaccine. The CDC has not identified any cases of these rare blood clots and low platelet counts among recipients of either; 5.2 million doses have been administered in the United States so far, per the CDC. Five potential cases of the rare clotting were identified but without the low platelet count observed in the case of the J&J vaccine.

“Individuals with questions about which vaccine is right for them should discuss their options with a medical provider,” Woodcock said.

Why are the CDC and FDA making this your decision?

Unlike some European regulators in the case of another adenovirus vaccine, the CDC and FDA did not limit the use of the J&J but chose instead to add a warning label.

Modeling shows that limiting the Johnson & Johnson vaccine to individuals above 50 would have severely reduced the vaccine’s ability to prevent hospitalizations and deaths nationally in all transmission scenarios. Vaccination is as much about a community as it is about an individual; vaccines have been proven to be effective at reducing transmission of the disease in addition to conferring immunity upon their recipients. The estimates look at direct and indirect benefits of vaccination with J&J over a six-month period in the United States.

Population-level modeling aside, the CDC also wanted to be sensitive to the fact that “some people want a one-and-done. Some people will not have access to another vaccine in the near future, and I think that this risk trade-off is one that people have to individually measure for themselves,” Walensky said.

The public should take heart in the fact that the CDC was able to identify rare clots, act on the knowledge quickly and conduct “rational risk-benefit analysis, which was done in the open,” said Saad Omer, director of the Yale Institute for Global Health. “This should be reassuring to people.”

https://ctmirror.org/2021/04/27/the-risks-of-getting-a-jj-shot-what-you-need-to-know/

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The best vaccination strategy is simple: Focus on Americans 65 and older

Now that covid-19 vaccines are increasingly becoming available to people beyond health-care workers and those in long-term care, the question turns to who should be immunized next. For many people, the answer is essential workers. But while many workers face an elevated risk and should receive a vaccine soon, we believe the most ethically justified path forward is to focus on individuals 65 and older.

The primary reason to prioritize people in this age group is simple: They account for more than 80 percent of covid-19 deaths, even though they are only about 16 percent of the population. This disproportionate toll is why the Biden administration’s vaccine plan encourages states to expand vaccine eligibility to those who are 65 and older.

But while many places — such as D.C., New York and Florida — are converging on a 65-and-older strategy, whether seniors qualify for vaccination largely depends on where they live. In New Mexico and Connecticut, you need to be at least 75 years old. In Colorado and Nevada, 70 is old enough. And in Hawaii and Virginia, older adults must compete with many other people for the same limited vaccine supply, including essential workers.

https://www.washingtonpost.com/opinions/2021/02/08/best-vaccination-strategy-is-simple-focus-americans-65-older/

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Portland Mayor Ted Wheeler Gets Mugged by Reality

Antifa, that figment of right-wing fever dreams, may have finally found a believer in hard-left Portland Mayor Ted Wheeler.

You remember antifa. It’s the black-clad, Portland-based anarchist mob that New York Congressman Jerrold Nadler famously dismissed as “a myth that’s being spread only in Washington, DC.”

A “myth,” Jerry? Try telling that to Ted Wheeler.

As The Wall Street Journal editorial board reports, “A well-known politician on Friday denounced ‘self-described anarchists who engage in regular criminal destruction’ and want to ‘burn,’ ‘bash’ and ‘intimidate.’ He called for ‘higher bail’ and ‘tougher pretrial restrictions’ on rioters. And he pleaded with the public to cooperate with police and identify miscreants: ‘Our job is to unmask them, arrest them, and prosecute them.’ Donald Trump? Sheriff Arpaio? Nope. That was Portland, Ore., Mayor Ted Wheeler, the über-progressive, who made a national reputation last year by apologizing for vandals and rioters he said were merely exercising their right to protest against an unjust America.”

All this is a humiliating flip-flop for the guy who enabled antifa to engage in a nearly year-long orgy of nonstop rioting, and the guy who last June vowed to defund his city’s police force. As The Oregonian’s Everton Bailey Jr. reported at the time, “Wheeler pledged the city will divert $12 million from the police bureau and other city departments to directly support communities of color, defund three police units including the gun violence reduction team and ban officers from using chokeholds as part of plans to reform the Portland Police Bureau.”

Wheeler, who’s also — get this — the city’s police commissioner, said, “My privilege as a white man, my privilege as the mayor and the leader of the institutions of power in this community I believe shielded me from time to time from the many difficult and uncomfortable truths about our history and about our society.”

Clearly, that mea culpa wasn’t good enough for antifa. Nor, we think, was it properly directed. Wheeler seemed to be trying to atone to the city’s black residents for his white privilege, but last time we checked, antifa was as lily-white as Wheeler.

In any case, as the Journal reports, unbridled antifa rioters “shot fireworks at law enforcement, firebombed government buildings, and set fire to cop cars and a police union hall” — all while the milquetoast mayor carried on like a modern-day Neville Chamberlain.

And now, he’s crying uncle. Yep, the guy who slashed $27 million from the city’s 2021 police funding, the guy who called Donald Trump’s decision to send in federal forces to quell the rioting last July “an attack on our democracy,” has finally been mugged by reality. He’s now begging for the citizens of Portland to start ratting out that mob he’s been trying to appease these many months.

As The Daily Wire’s Emily Zanotti reports, “Wheeler extended a city-wide state of emergency and begged for Portland residents to assist law enforcement in ‘unmasking’ and identifying members of the ‘self-described anarchist mob’ that have rioted through the city nearly every night since last May.”

Wheeler, it seems, has learned a valuable lesson in human nature: Weakness is provocative. Better late than never.

And who knows? Maybe Wheeler’s wisdom will wind its way north to Seattle, where the people clearly want law and order, and where feckless Mayor Jenny Durkan seems to be holding out hope for that Summer of Love.

https://patriotpost.us/articles/79481-ted-wheeler-gets-mugged-by-reality-2021-04-28

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Also see my other blogs. Main ones below:

http://snorphty.blogspot.com (TONGUE-TIED)

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS

http://awesternheart.blogspot.com.au/ (THE PSYCHOLOGIST)

https://heofen.blogspot.com/ (MY OTHER BLOGS)

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