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Moderna, J&J Boosters to Get Debated By FDA Advisory Panel This Week – Barron's

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Johnson & Johnson stock is up 1.8% this year. Here, a syringe filled with the company’s Covid-19 vaccine.


Robyn Beck / AFP via Getty Images

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An advisory panel of the Food and Drug Administration will meet later this week to consider whether the agency should authorize boosters of both the Moderna and Johnson & Johnson vaccines for Covid-19.

The FDA’s vaccines advisory committee is scheduled to consider the Moderna (ticker: MRNA) booster on Thursday and the




Johnson & Johnson

(JNJ) booster on Friday.

Committee members also will hear a presentation on a so-called mix-and-match booster, or a dose of a vaccine different from the original one.

The Centers for Disease Control and Prevention has scheduled meetings of its own vaccines advisory committee for Oct. 20 and 21 to consider the Moderna and Johnson & Johnson boosters.

The timing suggests the boosters could be rolled out late next week if both committees and their respective agencies line up in favor of the shots.

Currently, only the vaccine from




Pfizer

(PFE) and




BioNTech

is authorized for a booster, and only those who received that vaccine initially are eligible. The FDA authorized the booster dose on Sept. 22; the CDC director followed up with a recommendation two days later.

Under the CDC and FDA guidance, those who are eligible for a Pfizer booster must have received the second dose at least six months ago and must be 65 or older, or have underlying medical conditions, or work in a high-risk setting such as a hospital.

Of the 187.3 million fully vaccinated people in the U.S., 103.1 million received Pfizer’s vaccine as their initial dose, according to CDC figures. That leaves tens of millions who either received the Moderna or Johnson & Johnson vaccine and can’t receive a booster, even if they would qualify otherwise.

The exception is for people with certain immunocompromising conditions that leave them less likely to fully respond to the vaccine. They can take a third dose of the Pfizer or Moderna vaccine as part of their initial vaccination series.

In September, the CDC panel members talked of being conflicted about allowing only Pfizer recipients to receive boosters.

“I just don’t understand how …we can say to people 65 and older, you’re at risk for severe disease and death, but only half of you can protect yourselves right now,” Dr. Sarah Long, a professor of pediatrics at Drexel University College of Medicine, said at the time. “It doesn’t sound like a good public health policy.”

The FDA committee voted overwhelmingly against a broad rollout of the Pfizer vaccine before eventually signing off on a more limited rollout for seniors and anyone at high risk of severe illness. In an informal poll at the end of their meeting, the members indicated they supported boosters for healthcare workers as well.

The FDA ended up authorizing boosters for healthcare workers. The CDC committee members, in a tight vote, voted against allowing boosters for younger people based on their occupation, but the CDC’s director, Dr. Rochelle Walensky, overturned their decision.

In the end, the booster rollout looks far more like the broad campaign that the Biden administration had proposed than the one based on the initial FDA advisory committee votes. 

In August, the White House laid out a plan—endorsed by both the CDC director and the acting FDA commissioner—that allowed all Americans to receive a booster beginning in late September.

The World Health Organization, meanwhile, has called for a moratorium on booster doses until the end of the year, pointing to the wide gap in vaccination rates between poor and developed countries.

Shares of the vaccine makers are up this year, although Moderna and BioNTech have dropped since Merck (MRK) announced last week that its oral antiviral performed well in a trial of high-risk adults with mild-to-moderate cases.

So far this year, Moderna is up nearly 200% and BioNTech is up just over 200%; Pfizer is up 14.4%.

Johnson & Johnson is up 1.8%, though the company is selling its vaccine at a not-for-profit price, and sales have no bearing on near-term earnings.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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Interior Health delivers nearly 800K immunization doses in 2023

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Interior Health says it delivered nearly 800,000 immunization doses last year — a number almost equal to the region’s population.

The released figure of 784,980 comes during National Immunization Awareness Week, which runs April 22-30.

The health care organization, which serves a large area of around 820,000,  says it’s using the occasion to boost vaccine rates even though there may be post-pandemic vaccine fatigue.

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“This is a very important initiative because it ensures that communicable diseases stay away from a region,” said Dr. Silvina Mema of Interior Health.

However, not all those doses were for COVID; the tally includes childhood immunizations plus immunizations for adults.

But IHA said immunizations are down from the height of the pandemic, when COVID vaccines were rolled out, though it seems to be on par with previous pre-pandemic years.

Interior Health says it’d like to see the overall immunization rate rise.

“Certainly there are some folks who have decided a vaccine is not for them. And they have their reasons,” said Jonathan Spence, manager of communicable disease prevention and control at Interior Health.

“I think there’s a lot of people who are hesitant, but that’s just simply because they have questions.

“And that’s actually part of what we’re celebrating this week is those public health nurses, those pharmacists, who can answer questions and answer questions with really good information around immunization.”

Mima echoed that sentiment.

“We take immunization very seriously. It’s a science-based program that has saved countless lives across the world and eliminated diseases that were before a threat and now we don’t see them anymore,” she said.

“So immunization is very important.”

 

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Remnants of bird flu virus found in pasteurized milk, FDA says

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The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.

The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.

“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement.

The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department says 33 herds have been affected to date.

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FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”

The PCR lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University

“There is no evidence to date that this is infectious virus and the FDA is following up on that,” Jaykus said.

Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.

Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.

Matt Herrick, a spokesman for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.

Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.

To date, two people in U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

 

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Canada Falling Short in Adult Vaccination Rates – VOCM

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Canada is about where it should be when it comes to childhood vaccines, but for adult vaccinations it’s a different story.

Dr. Vivien Brown of Immunize Canada says the overall population should have rates of between 80 and 90 per cent for most vaccines, but that is not the case.

She says most children are in that range but not for adult vaccines and ultimately the most at-risk populations are not being reached.

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She says the population is under immunized for conditions such as pneumonia, shingles, tetanus, and pertussis.

Brown wants people to talk with their family physician or pharmacist to see if they are up-to-date on vaccines, and to get caught up because many are “killer diseases.”

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