Covid vaccines provide stronger immunity than past infection, CDC study finds

Vaccination offers stronger protection against Covid than a previous infection, according to a CDC study.

Source: https://www.nbcnews.com/health/health-news/covid-vaccines-provide-stronger-immunity-infection-cdc-study-finds-rcna4133
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The Article Was Written/Published By: Sara G. Miller and Akshay Syal, MD

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FDA authorizes first Covid vaccine for kids ages 5-11

The Food and Drug Administration on Friday authorized the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11.

The hotly anticipated decision will allow roughly 28 million American children to be vaccinated against the coronavirus, with shots rolling out just as flu season starts and with major holidays looming.

The FDA’s action comes days after its independent vaccine advisory committee voted 17-0, with one abstention, to recommend use of the Pfizer-BioNTech shot in younger children. Panel members were swayed in part by data from the Centers for Disease Control and Prevention that showed children ages 5-11 are “at least as likely” as adults to contract the virus, and that hospitalization rates are three times higher among children of color than among while children.

The CDC’s vaccine advisers are scheduled to meet Tuesday to evaluate the shot, and are expected to vote in favor of its use in 5- to 11-year-olds. The final step before the vaccine rolls out will be formal endorsement by CDC Director Rochelle Walensky.

Source: https://www.politico.com/news/2021/10/29/fda-authorizes-first-covid-vaccine-for-kids-ages-5-11-517679
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The Article Was Written/Published By: Lauren Gardner

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LA to deduct test costs from paychecks of unvaccinated officers, firefighters, city employees

The Los Angeles City Council approved a plan on Tuesday that calls for deducting the cost of COVID-19 tests from the paychecks of police officers, firefighters and other city workers who remain unvaccinated….

Source: https://thehill.com/homenews/state-watch/578660-la-to-deduct-test-costs-from-paychecks-of-unvaccinated-police-officers-firefighters
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The Article Was Written/Published By: Mychael Schnell

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Moderna says COVID vaccine shows strong immune response in younger kids

Moderna on Monday released trial results for its coronavirus vaccine for children aged 6 to 11, saying it provides a “robust” immune response after two doses.

Why it matters: Moderna said it will officially submit the results to the Food and Drug Administration for authorization in “the near term,” meaning we could soon see two coronavirus vaccines available to protect approximately 28 million more kids in the U.S.

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• The FDA is set to authorize the Pfizer-BioNTech vaccine for children soon. Regulators said last week that the benefits of the vaccine outweigh the risks for children between the ages of 5 and 11.

The big picture: The Biden administration released a plan last week to “quickly” vaccinate children between the ages of 5 and 11 after the FDA and the Centers for Disease Control and Prevention authorize a vaccine for that age group.

How it works: Moderna’s trial examined “4,753 participants who were 6 to less than 12 years of age,” the company said.

• Trial participants received two 50 micrograms vaccine doses, half the dose given to adults.
• Most side effects “were mild or moderate in severity.” The most common were fatigue, headache, fever and injection site pain.

What to watch: Moderna said it will “soon” submit its results to the FDA, the European Medicines Agency and other global health regulators.

Go deeper: COVID vaccines for kids are getting closer

Source: https://www.axios.com/moderna-immune-response-children-covid-vaccine-565ab808-bb11-44d2-99d0-5b96c04604b7.html
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The Article Was Written/Published By: Oriana Gonzalez

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Moderna says COVID vaccine shows strong immune response in younger kids

Moderna on Monday released trial results for its coronavirus vaccine for children aged 6 to 11, saying it provides a “robust” immune response after two doses.

Why it matters: Moderna said it will officially submit the results to the Food and Drug Administration for authorization in “the near term,” meaning we could soon see two coronavirus vaccines available to protect approximately 28 million more kids in the U.S.

---

• The FDA is set to authorize the Pfizer-BioNTech vaccine for children soon. Regulators said last week that the benefits of the vaccine outweigh the risks for children between the ages of 5 and 11.

The big picture: The Biden administration released a plan last week to “quickly” vaccinate children between the ages of 5 and 11 after the FDA and the Centers for Disease Control and Prevention authorize a vaccine for that age group.

How it works: Moderna’s trial examined “4,753 participants who were 6 to less than 12 years of age,” the company said.

• Trial participants received two 50 micrograms vaccine doses, half the dose given to adults.
• Most side effects “were mild or moderate in severity.” The most common were fatigue, headache, fever and injection site pain.

What to watch: Moderna said it will “soon” submit its results to the FDA, the European Medicines Agency and other global health regulators.

Go deeper: COVID vaccines for kids are getting closer

Source: https://www.axios.com/moderna-immune-response-children-covid-vaccine-565ab808-bb11-44d2-99d0-5b96c04604b7.html
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The Article Was Written/Published By: Oriana Gonzalez

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CDC approves boosters for Moderna and J&J and mix-and-match

The Centers for Disease Control and Prevention’s independent advisory panel voted unanimously to recommend booster doses of Moderna and Johnson & Johnson vaccine and allow people to mix-and-match doses.

The big picture: The agency aligns with the Food and Drug Administration authorization Wednesday night which said people could switch to whichever vaccine they wanted for their booster shot.

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Details: Boosters for Moderna’s two-dose vaccine and J&J’s single-dose shot may be taken by Americans over 65, as well as those over 18.

• Dosing for the Moderna booster will be less than its two-dose regiment and will be permitted six months after the third shot. J&J will be allowed after two months.
• The Food and Drug Administration authorization Wednesday night greenlit people could switch to whichever vaccine they wanted for their booster shot and authorized boosters for certain populations.

Still, the Advisory Committee on Immunization Practices panel weighed the challenge in allowing younger people to for a booster qualify based on increased exposure to risk, despite lack of data.

• Sarah Long, a committee member also at Drexel University College of Medicine raised concerns on the contentious topic of opening up booster eligibility to all adults.
• “I can’t say I am comfortable that anyone under 50, otherwise healthy, needs a booster at this time,” she said in the meeting Thursday.

The panel also heard safety updates about the rare risk of inflammatory heart problems such as myocarditis among recipients of Moderna and Pfizer-BioNTech vaccines, especially in men ages 18 to 24.

• Serious side effects after all vaccines are extremely rare, five separate updates on vaccine safety showed.

State of play: Public health experts see a positive effect in unifying recommendations specific populations who took any of the three vaccines.

• The committee in late September did not support a Pfizer booster for people in high-risk workforces but was overruled by CDC director Rochelle Walensky. There’s no indication the director wouldn’t do the same if the panel voted narrowly again.
• Though the agency’s recommendations hold a large influence among the medical community, state and local health departments could veer from the guidance.

What’s happening: There’s also been debate whether once again the agency has acted too slowly in mixing-and-matching guidance for those who received J&J.

• “We have to acknowledge we’re in a situation where we don’t have as much data as we would like. But we still have to make practical decisions and I think there’s as much data to support mixing and matching as there is for boosters in general,” John Whyte, chief medical officer of WebMD, tells Axios.
• For months, small samples of preliminary booster data suggest neutralizing antibodies from an mRNA shot like Moderna would increase 76 times and 35 times with Pfizer as opposed to only four times with another J&J shot.

What’s next: Walensky has the final say and could sign off on the guidance for clinicians and pharmacies to rollout third shots as soon as Friday.

Source: https://www.axios.com/cdc-guidance-boosters-mix-and-match-902c873a-e0ee-4dd7-808a-924e415463fa.html
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Fauci says FDA data shows J&J vaccine should have been two shots

President Biden’s chief medical adviser Anthony Fauci said on Sunday that the Johnson & Johnson COVID-19 vaccine likely should have been a two-dose shot instead of a single inoculation. ABC’s Marth…

Source: https://thehill.com/homenews/administration/577108-fauci-says-jj-vaccine-should-have-likely-been-two-dose-shot
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The Article Was Written/Published By: Caroline Vakil

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FDA advisers endorse Moderna booster shot: Three takeaways

The Food and Drug Administration’s vaccine advisory panel on Thursday unanimously endorsed use of Moderna’s Covid-19 booster shot for the elderly and younger people whose jobs, underlying health or other factors elevate their risk.

The panel recommended giving the shots at least six months after initial immunization. Its vote is not binding, but the FDA normally follows the recommendations of its advisory committees.

The Moderna plan endorsed by the panel would apply to largely the same groups currently eligible for the Pfizer-BioNTech booster shot. For now, federal regulators only are planning to endorse giving people boosters from the same manufacturer as their initial shots, though the independent advisers will review preliminary data on Friday on so-called “mix-and-match” boosting.

The FDA panel’s Friday meeting will also take up of Johnson & Johnson’s proposed booster.

Here are three takeaways from the first day of the FDA panel’s two-day meeting:

Regulators are grappling with incomplete data

Despite the unanimous vote, some panel members lamented the skimpy data they had to rely upon to make their decision — and that the Pfizer precedent made it difficult for them to go in a different direction with Moderna.

Panel member Patrick Moore, a professor at the University of Pittsburgh Cancer Institute, said he had some “real issues” with the vote result, based on questions about the quality of Moderna’s data.

“I just want to explain why I voted yes; it is more gut feeling rather than based on really truly serious data,” he said, adding: “The data itself is not strong, but it is certainly going in a direction that is supportive of this.”

Moderna, like other vaccine manufacturers, continues to reference antibody response as a sign that people have built a level of immunity against the coronavirus. But FDA regulators at the meeting admitted they still are not entirely sure what is the best yardstick, or “correlate of protection,” by which to measure how well — and how long — the shots work.

University of Pennsylvania vaccine expert Paul Offit, an advisory committee member, lamented using antibody response as a measuring stick when data seemed to indicate that immunity grew over time after two doses. He also criticized thinking of mild and asymptomatic breakthrough infections as a sign of failure or a weak vaccine.

“If the goal is to try and protect against the unfortunately-named breakthrough infections of asymptomatic infection… then we’re going to be talking about getting frequent boosters, which I don’t think is a reasonable strategy for this,” Offit said.

Another panel member, Cody Meissner of Tufts University School of Medicine, expressed concern over the wording of the recommendation for people whose jobs or living situations put them at high risk. He argued that while those people have a greater chance of exposure to the virus, they may not necessarily be more susceptible to severe disease.

“If we can’t defend these recommendations based on evidence, I think it’s going to further complicate getting this vaccine into every single adult American, and that’s really what we want to do,” he said.

Not all vaccines are created equal

Moderna’s presentation to the committee outlined the company’s rationale for proposing a half-dose booster shot, unlike the full doses authorized or proposed for Pfizer and Johnson & Johnson.

“We believe we should vaccinate with the lowest amount of antigen needed to induce an immune response,” said Jacqueline Miller, Moderna’s senior vice president for infectious diseases.

A lower dose is enough to reactivate the body’s immune memory to initial vaccination, she said — and it could help stretch the world’s supply of the Moderna shot.

Moderna’s half-dose booster did not produce the fourfold increase in antibodies that FDA has set as a bar for authorizing boosters, but Miller said that was because participants in the company’s booster studies had high antibody levels to begin with.

“Subjects who did not meet the fourfold rise definition are still deriving substantial benefit from the 50 micrograms booster dose,” she said.

But some panel members questioned whether the smaller dose would provide as long-lasting protection as a full-dose booster.

Moderna’s presented data on the immune response from a full booster dose that suggest immune cells were able to ward off the virus even after antibody levels dropped significantly.

“I don’t know if FDA has a sense of how that will change going from 100 [micrograms] to 50 [micrograms],” said Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translation Sciences. “That may have a tremendous impact on durability.”

Global vaccine equity concerns are coloring the booster debate

FDA staff have tried to keep the agency’s vaccine advisers from veering into broader discussions about equity during booster meetings, but the issue surfaced multiple times Thursday.

Miller began her morning presentation by arguing that the company’s proposed half-dose booster would help stretch the world’s vaccine supply.

Just under half of the world’s population has received at least one dose of a Covid-19 vaccine, but most of those shots have been administered in the richest countries. African countries in particular have struggled to vaccinate their populations.

Miller faced more pointed questions later in the day about Moderna’s role in closing the global vaccine gap from panel member Randy Hawkins, a physician specializing in pulmonary and internal medicine at Charles Drew University and in private practice.

He pressed Miller about criticism that Moderna has lagged in producing doses for low-income countries, either directly or through the global vaccine aid program known as COVAX.

“What is Moderna’s commitment to COVAX and other steps it will take to control the pandemic in countries suffering disproportionately?” he asked Miller.

She noted that the company has said it will not enforce its intellectual property protections against generic versions of vaccine during the pandemic and has delivered 50 million doses to COVAX as of September. Moderna has also committed to build a manufacturing plant in Africa — although she could not say when or where that would open.

“We also have plans to distribute 1 billion doses to low-income countries in 2022, and even though it includes greater complexity, we are reducing the [booster] dose to 50 micrograms in order to make more vaccine available for the world,” Miller said.

Source: https://www.politico.com/news/2021/10/14/fda-moderna-booster-takeaways-516031
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Judge rules Maine can bar religious exemptions to health care vaccine mandate

A U.S. District judge on Wednesday ruled that Maine could prohibit religious exemptions to its COVID-19 vaccine mandate for healthcare workers.Judge Jon Levy found that the health care workers who brought the case…

Source: https://thehill.com/homenews/state-watch/576662-judge-rules-maine-can-bar-religious-exemptions-to-vaccine-mandate
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The Article Was Written/Published By: Joseph Choi

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White House tells states to prepare plans to vaccinate kids in coming weeks

The White House coronavirus task force on Tuesday urged state leaders to be ready to begin rolling out COVID-19 vaccination efforts for kids as early as the start of next month.Administration…

Source: https://thehill.com/policy/healthcare/576587-white-house-tells-states-to-prepare-vaccination-plans-for-kids-in-coming
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WHO approves the first malaria vaccine

Exciting vaccine news that’s not about Covid: there’s now a WHO-approved vaccine for malaria, a disease caused by a single-celled microorganism of the Plasmodium group— not a bacteria or virus. According to the NYT, this vaccine is “the first developed for any parasitic disease. — Read the rest

Source: https://boingboing.net/2021/10/08/who-approves-the-first-malaria-vaccine.html?utm_source=rss&utm_medium=rss&utm_campaign=who-approves-the-first-malaria-vaccine
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American, Alaska Airlines and JetBlue the latest carriers to mandate COVID vaccines for workers

American Airlines, JetBlue and Alaska Airlines have joined United Airlines in mandating that employees must be vaccinated against COVID-19, per the Wall Street Journal.

Why it matters: The Biden administration has been pressing businesses to require workers to be vaccinated against the virus as vaccination rates flatten across the U.S.

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• The airlines provide government services including cargo hauling and special flights, which they say makes them contractors to the government so they fall under President Biden’s mandatory vaccination directive, AP reports.

The big picture: American Airlines told staff on Friday that it would require all employees based in the U.S. and “certain international crew members” to be vaccinated, per a memo obtained by Reuters.

• The American memo gave no timeline. But JetBlue Airways and Alaska Airlines said Friday they’d implement a vaccine mandate as early as Dec. 8, AP notes. That’s the deadline the White House has given for federal contractors to be inoculated, with limited exceptions.
• Delta said it’s “still evaluating Biden’s order,” according to AP.

Source: https://www.axios.com/american-alaska-airlines-jetblue-employee-vaccine-mandates-33ba1e4b-3662-4331-a58f-fabdc19aa23d.html
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The Article Was Written/Published By: Axios

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New York sees increase in health worker vaccinations following mandate

New York’s mandate for health workers to get vaccinated against COVID-19 has boosted the industry’s vaccination rate, and has not resulted in widespread facility closures and mass resignations like some state offici…

Source: https://thehill.com/policy/healthcare/574885-new-york-sees-increase-in-health-worker-vaccinations-following-mandate
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Delta variant fears, hospitals filling up drove recent uptick in vaccination rate, poll finds

Knowing someone who became seriously ill or who died of Covid was another major reason cited, according to the Kaiser Family Foundation survey.

Source: https://www.nbcnews.com/news/us-news/delta-variant-fears-hospitals-filling-drove-recent-uptick-vaccination-rate-n1280234
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Biden receives Covid-19 booster shot, days after CDC recommends a third dose for his age range

The president said that while booster shots are important, too many Americans are still unvaccinated.

Source: https://www.nbcnews.com/politics/white-house/biden-receive-covid-booster-shot-camera-monday-n1280181
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The Article Was Written/Published By: Lauren Egan

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Federal judge deals blow to vaccine mandate for NYC teachers

NEW YORK — New York City schools have been temporarily blocked from enforcing a vaccine mandate for its teachers and other workers by a federal appeals judge just days before it was to take effect.

The worker mandate for the the nation’s largest school system was set to go into effect Monday. But late Friday, a judge for the 2nd U.S. Circuit Court of Appeals granted a temporary injunction and referred the case to a three-judge panel an an expedited basis.

Department of Education spokesperson Danielle Filson said officials seeking a speedy resolution by the circuit court next week.

“We’re confident our vaccine mandate will continue to be upheld once all the facts have been presented, because that is the level of protection our students and staff deserve,” Filson said in an email.

She said more than 82% of department employees have been vaccinated.

While most school workers have been vaccinated, unions representing New York City principals and teachers warned that could still leave the 1 million-student school system short of as many as 10,000 teachers, along with other staffers, such as cafeteria workers and school police officers.

New York City Mayor Bill de Blasio has resisted calls to delay the mandate.

Source: https://www.politico.com/news/2021/09/25/vaccine-mandate-nyc-teachers-514297
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US Border Patrol seizes thousands of fake vaccine cards and Pfizer stickers

The US Border Patrol has reported seizing thousands of fake COVID-19 vaccination cards and Pfizer inoculation seals, the latest confiscation in what has been at least several thousand counterfeit cards found by customs officers this year. The latest batch arrived at the Port of Cincinnati in multiple shipments. The latest Customs and Border Patrol seizure of counterfeit COVID-19 cards was … Continue reading

Source: https://www.slashgear.com/us-border-patrol-seizes-thousands-of-fake-vaccine-cards-and-pfizer-stickers-18691372/
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Cuba begins vaccinating children as young as two against COVID-19

Cuba, using its homegrown vaccines, is one of the first nations to begin vaccinating very young children.

Source: https://www.aljazeera.com/news/2021/9/17/cuba-begins-vaccinating-children-as-young-as-two-against-covid-19
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Seattle area to require COVID-19 vaccine to enter indoor venues

Customers at Seattle-area restaurants, gyms and other indoor venues will soon be required to provide proof of vaccination against COVID-19 under a new county health order issued Thursday. …

Source: https://thehill.com/policy/healthcare/572710-seattle-area-to-require-covid-19-vaccine-to-enter-indoor-venues
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Moderna may have the effectiveness edge over Pfizer

Recent data suggests that Moderna’s coronavirus vaccine may maintain a higher effectiveness over time than Pfizer’s.

Why it matters: The effectiveness gap could always disappear with more data, and both vaccines remain very effective against severe disease. But if the gap does hold up, it raises questions about whether the two vaccines should be treated the same way policy-wise.

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Driving the news: Several studies — both preprints and those that have been peer-reviewed — have found a difference between the two vaccines’ effectiveness over time, although some experts have cautioned that this could stem from flawed head-to-head comparisons.

• The studies have evaluated different measures of effectiveness, but all have found that effectiveness against severe disease remains relatively high.
• “There have been sort of signals from enough separate sources that start to paint a picture that may reflect a real biological phenomenon — a real difference. I’m starting to believe that there’s something underlying it,” said Natalie Dean, an Emery professor who specializes in vaccine study design.

Zoom in: In a study released last week, the CDC found that Moderna was significantly more effective against hospitalizations and emergency department or urgent care encounters than the Pfizer or J&J vaccines.

• A second smaller study found more similar effectiveness level against hospitalization between the two mRNA vaccines.

Between the lines: Pfizer was the first vaccine authorized for use in the U.S. and began being administered several weeks before the Moderna vaccine.

• “Because of the way the rollouts happened, the oldest and most vulnerable and sickest people, like nursing home residents, got Pfizer,” said Cornell virologist John Moore.
• That means it’s possible that some of the effectiveness gap showing up in some studies is a result of Pfizer being administered earlier and in more vulnerable populations.
• However, the large CDC study that found a significant difference in the vaccines’ effectiveness found that Moderna’s was higher across all ages.

Possible reasons for the difference include that Moderna has a much higher dosing regimen than Pfizer, and the second shot is given after a slightly longer interval.

• And, while the vaccines are both made using mRNA technology, they have structural differences.

Yes, but: Both vaccines are nearly equal in their capacity to “do what a vaccine needs to do, which is protect against severe illness,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

The bottom line: The Moderna data may more closely resemble Pfizer’s after more time passes. But it may be unwise to use one as a proxy for the other.

• “It’s not clear that any lesson we see from Pfizer will directly translate to Moderna,” Dean said. “I think if you asked this question a few months ago, when there really [weren’t] any signals of a difference, people would very much lump them together in their mind.”

What we’re watching: There’s a lot more data — particularly from other countries, like Israel — on Pfizer’s waning effectiveness, and the effect of booster shots on restoring effectiveness to original levels.

• But if that data isn’t applicable to Moderna, regulators may not yet have much data to work with when making booster decisions — a process that is already highly controversial.
• “We won’t know the real Moderna-specific data for some time now, about restoring effectiveness and how durable that is,” said Eric Topol, executive vice president of Scripps Research.
• Topol said there have been signs Moderna’s effectiveness wanes over time to some degree. “It just may be longer and it may be less,” Topol added.

Source: https://www.axios.com/pfizer-moderna-coronavirus-vaccines-effectiveness-data-4a681617-d887-4b21-93a3-d6c2d9d51b31.html
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The Article Was Written/Published By: Caitlin Owens

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