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Politics Overnight Health Care: Johnson & Johnson delay prompts criticism of CDC panel | Pfizer CEO says third dose of COVID-19 vaccine 'likely' needed within one year | CDC finds less than 1 percent of fully vaccinated people got COVID-19

01:40  16 april  2021
01:40  16 april  2021 Source:   thehill.com

U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted

  U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted San Diego State’s Klara Thormalm has been named the Mountain West Swimmer of the Year as voted on by the league’s coaches. Wyoming’s Melissa Mirafuentes was selected as the MW Diver of Year.

Welcome to Thursday's Overnight Health Care. A researcher at the University of Illinois Urbana-Champaign (UIUC) fought to have her service dog with her in the lab, and even went so far as to outfit him with the same PPE she wore- goggles, boots and a lab coat.

text, letter: Johnson & Johnson coronavirus vaccine © Getty Images Johnson & Johnson coronavirus vaccine

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Today: Pfizer's CEO said a booster shot is likely needed within a year of getting the first one. A CDC advisory panel's punt on making a decision about the Johnson & Johnson vaccine is drawing criticism from people who supported the initial pause. The agency is also sharing the number of "breakthrough" infections of people who have been vaccinated.

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We'll start with J&J:

Johnson & Johnson delay prompts criticism of CDC panel

There was a lot of anticipation for a CDC advisory committee meeting Wednesday on the Johnson & Johnson vaccine delay, and they...punted.

The panel decided they didn't have enough evidence to make a decision one way or the other, and decided to reconvene in a week to 10 days to talk again.

That lack of a decision, effectively extending the delay on using the vaccine, is drawing criticism from experts:

  • Leana Wen of George Washington University: "There is a vacuum for anti-vaccine activists to put out disinformation in this time," Wen said, while also noting "we are in the middle of a pandemic" and there are "hundreds of people dying every day."
  • Paul Offit of Children's Hospital of Philadelphia: "You have an abundance of evidence that this is a real but rare problem," Offit said. "I just don't know what they're waiting for."
  • Ashish Jha of the Brown School of Public Health: "The risk-benefit here is all wrong."

An alternative to the delay: The panel discussed multiple options, including limiting by age or gender. The FDA even said they would be open to adding a warning on the vaccine's label if it meant a recommendation to continue. The panel ultimately decided on none of them.

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The six cases of blood clots that prompted the pause were in women aged 18-48, so the CDC panel could have kept the vaccine paused for that demographic group while restarting it for others, Jha said.

Asked if the White House was frustrated by the delay, White House press secretary Jen Psaki said Thursday: "Science moves at the speed of science and they want to review more data."

Read more here.

Another shot? Pfizer CEO says third dose of COVID-19 vaccine 'likely' needed within one year

Pfizer's CEO Albert Bourla said that COVID-19 vaccine recipients will "likely" need a third dose between six to 12 months after they're fully vaccinated.

Bourla told CNBC's Bertha Coombs at a CVS Health event that a "likely scenario" based on current data is that the COVID-19 vaccine would need to be given annually, similar to the flu shot.

What he said: "A likely scenario is there will be likely a need for a third dose somewhere between six and 12 months and then from there there would be an annual revaccination."

FDA, CDC recommend pausing use of Johnson & Johnson vaccine after reports of rare but severe blood clots

  FDA, CDC recommend pausing use of Johnson & Johnson vaccine after reports of rare but severe blood clots Officials recommended the pause 'out of an abundance of caution,' saying blood clots still seem to be 'extremely rare,' according to a statement.The health agencies released a statement Tuesday morning recommending the pause “out of an abundance of caution,” saying blood clots still seem to be “extremely rare.” So far, the CDC and FDA are reviewing six reported cases in the U.S.

"But all of that needs to be confirmed and again the variants will play a key role," he continued. "It is extremely important to suppress the pool of people that can be susceptible to the virus because they are vaccinated with high-efficacy vaccines."

What we know: Pfizer and its German partner BioNTech reported earlier this month that their vaccine remained 91 percent effective at least six months after the second dose.

Bourla said the six months of data shows "extremely, extremely high" protection from COVID-19, noting that protection still "goes down by time."

Read more here.

"Breakthrough" cases: CDC finds less than 1 percent of fully vaccinated people got COVID-19

The CDC reported about 5,800 "breakthrough" COVID-19 cases among the millions of Americans who are fully vaccinated, totaling far less than 1 percent of fully vaccinated people.

Out of the recorded breakthrough cases, about 7 percent resulted in hospitalization, and about 1 percent of people who contracted it after being vaccinated died.

The breakthrough COVID-19 infections reported to the CDC were out of more than 75 million fully vaccinated individuals in the U.S., occurring in less than 0.008 percent of fully vaccinated people. Hospitalizations have occurred in 0.0005 percent of all full vaccinations and deaths in almost 0.0001 percent.

America is about to hit a 'vaccine wall' as demand drops — with or without Johnson & Johnson

  America is about to hit a 'vaccine wall' as demand drops — with or without Johnson & Johnson When U.S. officials temporarily paused the use of Johnson & Johnson’s COVID-19 vaccine Tuesday to warn patients and providers of an “extremely rare” blood clotting issue that has so far affected just six of the millions of Americans who have received the vaccine — all six of them women ages 18 to 48 — many observers worried the abrupt move would stop a substantial number of Americans from getting vaccinated. Because even before the J&J news, theBut if you take a closer look at the data, it’s clear that unless regulators end up pulling J&J from the market — an outcome experts have all but ruled out, given the vaccine’s robust track record of safety and effectiveness and the relatively minuscule risk of clotting — th

"Vaccine breakthrough infections make up a small percentage of people who are fully vaccinated," the CDC told The Hill in a statement. "CDC recommends that all eligible people get a COVID-19 vaccine as soon as one is available to them."

The CDC said the current data does not find "unexpected patterns" in "demographics or vaccine characteristics."

Why this happens: COVID-19 vaccines are not 100 percent effective, meaning that some who are vaccinated will still become infected. The key is to monitor the cases for symptoms of "long COVID," as well as to figure out some of the common characteristics of people who have these infections to understand why it happens.

Read more here.

Becerra: NIH to make announcement on fetal tissue research policy amid Trump-era restrictions

The NIH plans to make an announcement on its fetal tissue research policy following a Trump administration ban, Health and Human Services (HHS) Secretary Xavier Becerra said on Thursday.

During a House Appropriations subcommittee hearing, Becerra said NIH "will be making an announcement I believe tomorrow" on the ban implemented in 2019.

"You want to keep your ears open for that," he said. "But we believe that we have to do the research that it takes to make sure that we're incorporating innovation and getting all of those types of treatments and therapies out there to the American people."

NHL's COVID protocol-related absences for April 17, 2021

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Republican member's response: Rep. Ben Cline (R-Va.) said, "I hope you're going to continue the Trump administration policy and that's going to be your announcement tomorrow."

Earlier this week: 26 Democratic House members sent a letter to Becerra calling for the Biden administration to end the Trump-era restriction, noting fetal tissue has been used in treatments for COVID-19 and to study Zika and HIV, among other diseases.

"The previous administration's restrictions on fetal tissue research continue to threaten scientific and medical advances by blocking intramural researchers from using the material and discouraging extramural researchers from pursuing research with it," the lawmakers wrote. "The Trump administration's policy was politically motivated and unnecessary."

Read more here.

NH governor will let mask mandate expire on Friday

New Hampshire Gov. Chris Sununu (R) said Thursday he will not renew the state's mask mandate, and will let it expire on Friday.

"We'll continue to work with public health to encourage social distancing and wearing of masks when appropriate. That will not change whatsoever. What does change is the government's imposed requirement to do so," Sununu said during a press conference.

New Hampshire is the first state in New England to lift its mask mandate, which has been in place since November.

Sununu said that private businesses, cities, towns, and organizations may continue to keep mask mandates in place.

Anyone over the age of 16 in New Hampshire is eligible to receive a vaccine, and 70 percent of residents over age 65 have gotten a shot. People from out of state will be able to get vaccinated on Monday.

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Next up: All remaining restrictions on businesses will be lifted May 7.

Read more here.

What we're reading

Spring wave of coronavirus crashes across 38 states as hospitalizations increase (Washington Post)

FDA seeks a new way to review old drugs without causing prices to soar (Kaiser Health News)

Vaccines won't protect millions of patients with weakened immune systems (New York Times)

Schools can open safely during COVID, the latest evidence shows (Scientific American)

State by state

New Colorado health insurance subsidies open as search for people eligible but not enrolled ramps up (Colorado Sun)

House committee tables bill to curtail powers of health officer, governor (Alabama Political Reporter)

Hosemann won't close door to Medicaid expansion in Mississippi (Natchez Democrat)

Op-eds in The Hill

Vaccine halt highlights pitfalls of effective public health policy

What's making the LGBTQ community sick? To start, discrimination and trauma

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