Johnson & Johnson’s vaccine should be considered a two-dose vaccine rather than the one-and-done shot that had received initial authorization, a federal panel decided Friday.

The committee felt all 15 million Americans who got a single dose of the “one and done” J&J vaccine would be substantially better protected with a second one. 

The unanimous decision from the Vaccines and Related Biological Products Advisory Committee came after real-world data showed J&J’s one-shot vaccine is not as effective as the Pfizer and Moderna vaccines in real-world studies

“Because the magnitude is lower than I think what would be desired – the estimates that have been seen with the mRNA vaccines – there is headroom to improve the efficacy,” said Dr. Penny Heaton, head of the vaccines global therapeutic area for Janssen Pharmaceuticals, a Johnson & Johnson company that developed the vaccine. 

Adding a second dose 2- to 6-months after the initial J&J shot would provide the same effectiveness as the mRNA vaccines without their fading protection, Heaton told the committee Friday.

The panel voted Thursday to support booster shots of the Moderna COVID-19 vaccine for people 65 and older, as well as younger adults with certain medical conditions or jobs that put them at increased risk for infection.

The committee decisions on both the Moderna and J&J supplementary shots still need to be verified by a different advisory panel as well as top federal officials. The CDC advisory panel is expected to meet Oct. 20 and 21 to discuss extra doses for Moderna and J&J recipients.

– Elizabeth Weise and Karen Weintraub

In the news also:

►The U.S. will allow vaccinated foreign nationals to enter the country starting Nov. 8 under a new international travel system. Foreign national air travelers will need to be vaccinated and provide proof of vaccination to fly to the U.S. and ahead of boarding will need to show a pre-departure negative test within three days of travel.

►Pennsylvania on Friday became the seventh state to report 1.5 million coronavirus cases. California has about 4.8million cases, Texas almost 4.2million, and Florida with more than 3.6 million.

►British health officials said Friday an estimated 43,000 people in England may have received false-negative COVID-19 test results due to problems at a private laboratory. 

►Italy’s strict vaccine requirements for all workers went into effect Friday. The rule requires all workers to show a health pass to get into their place of employment. Police were out in force as protests against the rule were expected and could turn violent.

►More than 100 workers at Los Alamos National Laboratory, the nuclear lab where the atomic bomb was created, are suing over a vaccine mandate that gives them until Friday to be vaccinated or fired. 

►Finnish President Sauli Niinsto’s office says he is self-isolating as a precaution after he may have been exposed to coronavirus following a meeting with a Latvian colleague in Sweden.

►Anyone age 12 and older will have to provide either proof of COVID-19 vaccination or a recent negative test to attend large events in Washington state starting Nov. 15.

📈 Today’s numbers: The U.S. has recorded more than 44.7 million confirmed COVID-19 cases and more than 721,500 deaths, according to Johns Hopkins University data. Global totals: More than 239.7 million cases and 4.8 million deaths. More than 188.2 million Americans — 56.7% of the population — are fully vaccinated, according to the CDC.

📘This is what we are reading Some college football players took advantage of COVID cutbacks to continue playing in the face of the pandemic. Doing so, created a “bewildering” dissonance between “spending as usual” and “poormouthing and penny-pinching” since the start of the pandemic, said Brian Goff, economics professor at Western Kentucky.

For the most recent news, keep checking this page. Want more? Sign up for USA TODAY’s Coronavirus Watch newsletter to receive updates directly to your inbox and join our Facebook group.

Minnesota mobilizes National Guard for hospital assistance

Governor Tim Walz said Friday he’ll use the Minnesota National Guard to help alleviate staffing shortages at hospitals and care facilities that are struggling to cope with the surge in COVID-19 cases among unvaccinated Minnesotans.

Governor Robbinsdale announced plans to alleviate bottlenecks at North Memorial Health Hospital, Robbinsdale. These are caused by an overworked staff that hinders hospitals’ ability to move patients into long-term and transitional care.

According to him, more than 400 Minnesota hospital patients are currently waiting at other centers for beds and are taking up space for new patients.

Walz stated that the exact number and roles of National Guard soldiers being deployed for assistance are still unknown.

– The Associated Press

COVID-19 vaccine lotteries didn’t work, new study says

According to Friday’s study in the Journal of the American Medical Association, the announcement of huge cash lotteries to reward people who have received the COVID-19 vaccination did not result in an increase in vaccines.

The authors are economists at U.S. universities and announced large-scale cash lotteries to boost vaccination uptake. The authors found “no statistically significant association” between the announcements and the number of vaccinations before or after the announcement date.

“Lottery-style drawings may be less effective than incentives that pay with certainty,” the authors wrote. “Another possibility is that drawings were not an informative vaccine promotional strategy and that more complete messaging on vaccination would have been far more effective.”

Similar conclusions were reached in a July study. That report by researchers at Boston University School of Medicine found Ohio’s lottery did not increase vaccination rates when compared with other states without lottery-based incentive systems. Multiple independent studies later showed that Ohio’s Vaxa-Million Giveaway contributed to the increase in vaccination rates.

– Grace Hauck

The CDC shows that vaccinated people fare better.

Newly released Centers for Disease Control and Prevention data shows how vaccinated people across age groups and with all three vaccine brands used in the United States fared much better with COVID-19 infections and deaths than the unvaccinated.

According to real-world data, people who were not vaccinated in August had a 11.3x higher chance of dying from COVID-19 than those who were vaccinated. They also had a 6.1x greater likelihood to be positive for the disease.

On the worst reported week of deaths around Aug. 8, for example, unvaccinated people died at a rate of 13.23 per 100,000, compared to Johnson & Johnson recipients at 3.14, Pfizer at 1.43 and Moderna at 0.73.

COVID-19 outcomes in the elderly are significantly affected by vaccines. People who were fully vaccinated at age 80 and older had a lower chance of dying from the disease than those in their 50s, 60s, or earlier. People who had been vaccinated in every age category were less likely than people not vaccinated.

According to the CDC, the data are from 16 countries that represent about 30% of the country’s population. These include New York City, Wisconsin, Utah and Wisconsin.

– Mike Stucka

The vaccinated traveler wants to go to America. You might not allow them in.

Jayaram Tadimeti, who was in India during the COVID-19 crisis earlier this year was very happy to be vaccinated. It’s something he regrets partially. 

He received Covaxin in two doses in May and June. The 32-year-old is concerned that his decision to get vaccinated will keep him from being able to visit friends and relatives in the U.S. next month, when they open the doors for international travelers. The country will only allow foreigners who are fully vaccinated using a drug approved either by the U.S. Food and Drug Administration, or the World Health Organization. Covaxin was not on that list, as it stands Thursday. 

U.S. officials’ decision to revamp the country’s entry requirements was welcome news for many travelers, but those who received vaccines that haven’t gotten the WHO’s stamp of approval are left wondering when they’ll get a chance to reconnect with loved ones in the states.

Tadimeti just moved to Toronto. Learn more

– Bailey Schulz

FDA convenes independent panel regarding Merck’s COVID pill

Thursday’s announcement by the Food and Drug Administration indicated that it will convene a group of experts to examine safety and efficacy data for Merck’s COVID-19 pill. Although these panels are standard in vaccine data review, FDA has yet to convene a panel of experts for COVID-19 treatment.

“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating,” said Dr. Patrizia Cavazzoni, director of FDA’s drug center.

This group will meet on Nov. 30. Merck’s pill won’t likely be approved until December, at the earliest.

Merck earlier this month stated that the trial data show the experimental drug has prevented half of the serious coronavirus-related infections that could otherwise have led to people being admitted to hospitals. 

‘Break up’ with J&J? Many are willing to give Moderna a try or Pfizer a chance.

As an FDA panel considers Johnson & Johnson booster shots Friday, a day after supporting lower-dose Moderna boosters, some recipients of the first J&J shot say they don’t necessarily want another dose of the company’s vaccine.

“I’m going to break up with J&J,” said Jill Oliver, 56, a resident of Boulder, Colorado. Her hesitation to have the shot for March was not surprising. She was reluctant to wait to receive a Moderna vaccine or a Pfizer vaccine but she heard the public health experts and received the vaccine she needed.

Oliver stated, “I believed I was doing what was right.” “Now, I’m walking around with my mask on and not feeling protected when I’m the one who stepped up to the plate and did what I was told.”

Studies have shown that while it remains highly effective at preventing severe illness and death, the J&J vaccine is less effective at preventing symptomatic COVID infection compared to Moderna and Pfizer. And the data on J&J’s boosters remains limited.

– Adrianna Rodriguez

Florida Governor vows to contest Biden’s COVID vaccination mandate

Governor Ron DeSantis announced Thursday that Florida would challenge the Biden administration’s mandate to vacate in federal court. Ron DeSantis declared Thursday that the current requirement for hospitals and businesses will be lifted.

President Joe Biden’s mandate has yet to be released but is expected this month. The mandate would cover hospitals that provide Medicare and Medicaid services, as well as employers employing 100 people or more.

In anticipation of the federal ruling, some Florida hospitals have COVID-19 requirements.

“We are going to contest that immediately,” DeSantis said Thursday at a Florida Department of Health office, where he was linking his promotion of monoclonal antibody treatments to the recent drop of COVID hospitalizations statewide. And I believe that the mandate will lose in court. It is my belief that it is our responsibility as a state to take all necessary steps to safeguard Floridians against mandates that could lead to them losing their jobs.

DeSantis has been firm in opposing vaccine requirements. He also quoted unverified data from monoclonal treatment centres that suggested large numbers of those seeking these treatments had been vaccinated. The USA TODAY Network — Florida filed a public records request more than a week ago seeking those figures. These figures have yet to be produced by Florida Department of Health.

– Frank Gluck, Fort Myers News-Press

Moderna booster is backed by elderly advisory panel

A federal advisory committee unanimously supported booster shots of the Moderna COVID-19 vaccine for people 65 and older, as well as younger adults with certain medical conditions or jobs that put them at increased risk for infection. The booster would be half the regular dose, given at least six months after the second shot.

Moderna’s booster could be given emergency authorization after the panel’s approval is reviewed by an additional advisory group and high-ranking officials from the Food and Drug Administration. Late last month, the Pfizer BioNTech additional shot was approved.

USA TODAY: Karen Weintraub, Elizabeth Weise

Contributing to The Associated Press

Source: USAToday.com

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