Austria plans vaccine drive in area hit by SA virus variant

Austria plans vaccine drive in area hit by SA virus variant

Austrian officials said Wednesday that they plan to offer vaccinations to most residents in a district that has seen significant numbers of infections with the South African coronavirus variant.

Tyrol province’s Schwaz district, east of the provincial capital of Innsbruck and home to about 84,000 people, has been a source of concern for weeks.

Schwaz accounts for 66 of 88 currently active confirmed cases of the more transmissible variant in the province, the Austria Press Agency reported.

The plan announced Wednesday calls for a vaccination drive starting next week. Health Minister Rudolf Anschober said the rollout will see vaccinations offered to all aged 16 and over.

APA reported that from around March 10, coinciding with the start of the drive and until it is complete, people will be required to get a negative coronavirus test before they could leave the Schwaz district.

The plan “is our opportunity to eliminate the variant in the Schwaz district,” Chancellor Sebastian Kurz said. He said numbers of active cases have already fallen.

The variant first identified in South Africa is a source of particular concern because of doubts over whether all vaccines currently available are fully effective against it.

Austrian officials said they have been able to bring forward the delivery of 100,000 doses of the Pfizer-BioNTech vaccine for Tyrol in cooperation with the European Union’s executive Committee and the manufacturers.

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Nanoparticle-delivered COVID-19 vaccine candidate shows promise in preclinical studies

Nanoparticle-delivered COVID-19 vaccine candidate shows promise in preclinical studies

Researchers from Cleveland Clinic’s Global Center for Pathogen Research & Human Health have developed a promising new COVID-19 vaccine candidate that utilizes nanotechnology and has shown strong efficacy in preclinical disease models.

According to new findings published in mBio, the vaccine produced potent neutralizing antibodies among preclinical models and also prevented infection and disease symptoms in the face of exposure to SARS-CoV-2 (the virus that causes COVID-19). An additional reason for the vaccine candidate’s early appeal is that it may be thermostable, which would make it easier to transport and store than currently authorized COVID-19 vaccines.

“Our vaccine candidate delivers antigens to trigger an immune response via nanoparticles engineered from ferritin—a protein found in almost all living organisms,” said Jae Jung, Ph.D., director of the Global Center for Human Health & Pathogen Research and co-senior author on the study. “This protein is an attractive biomaterial for vaccine and drug delivery for many reasons, including that it does not require strict temperature control.”

Added Dokyun (Leo) Kim, a graduate student in Dr. Jung’s lab and co-first author on the study, “This would dramatically ease shipping and storage constraints, which are challenges we’re currently experiencing in national distribution efforts. It would also be beneficial for distribution to developing countries.”

Other benefits of the protein nanoparticles include minimizing cellular damage and providing stronger immunity at lower doses than traditional protein subunit vaccines against other viruses, like influenza.

The team’s vaccine uses the ferritin nanoparticles to deliver tiny, weakened fragments from the region of the SARS-CoV-2 spike protein that selectively binds to the human entry point for the virus (this fragment is called the receptor-binding domain, or RBD). When the SARS-CoV-2 RBD binds with the human protein called ACE2 (angiotensin-converting enzyme 2), the virus can enter host cells and begin to replicate.

The researchers tested their vaccine candidate on a ferret model of COVID-19, which reflects the human immune response and disease development better than other preclinical models. Dr. Jung, a foremost authority in virology and virus-induced cancers, previously developed the world’s first COVID-19 ferret model—a discovery that has significantly advanced research into SARS-CoV-2 infection and transmission.

In this study, the researchers administered an initial dose of the vaccine candidate followed by two booster vaccines given 14 and 28 days later. One group received the vaccines intramuscularly, while another group received them both intramuscularly and intranasally.

After the second booster, all vaccinated models produced strong neutralizing antibodies. This suggests that repeated exposure to the RBD antigen successfully prepared the immune systems to rapidly fight the virus.

A few days after the second booster (31 days after the initial vaccine dose), the researchers exposed the models to high concentrations of SARS-CoV-2. Compared to the placebo group that received adjuvant-only vaccines (adjuvants are added ingredients that help vaccines work better), those that received the RBD-nanoparticle vaccine were better protected from clinical symptoms and lung damage associated with infection. The findings suggest the vaccine candidate helped prevent infection and serious disease.

Combination intramuscular and intranasal immunization showed more potent protective immunity and faster viral clearance than intramuscular immunization alone. Both were significantly more effective than the adjuvant-only vaccine. More research will be important to uncover the mechanisms behind these differential benefits.

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Tensions over vaccine equity pit rural against urban America

Tensions over vaccine equity pit rural against urban America

Rita Fentress was worried she might get lost as she traveled down the unfamiliar forested, one-lane road in rural Tennessee in search of a coronavirus vaccine. Then the trees cleared and the Hickman County Agricultural Pavilion appeared.

The 74-year-old woman wasn’t eligible to be vaccinated in Nashville, where she lives, because there were so many health care workers to vaccinate there. But a neighbor told her the state’s rural counties had already moved to younger age groups and she found an appointment 60 miles away.

“I felt kind of guilty about it,” she said. “I thought maybe I was taking it from someone else.” But late that February day, she said there were still five openings for the next morning.

The U.S. vaccine campaign has heightened tensions between rural and urban America, where from Oregon to Tennessee to upstate New York complaints are surfacing of a real—or perceived—inequity in vaccine allocation.

In some cases, recriminations over how scarce vaccines are distributed have taken on partisan tones, with rural Republican lawmakers in Democrat-led states complaining of “picking winners and losers,” and urbanites traveling hours to rural GOP-leaning communities to score COVID-19 shots when there are none in their city.

In Oregon, state GOP lawmakers walked out of a Legislative session last week over the Democratic governor’s vaccine plans, citing rural vaccine distribution among their concerns. In upstate New York, public health officials in rural counties have complained of disparities in vaccine allocation and in North Carolina, rural lawmakers say too many doses were going to mass vaccine centers in big cities.

In Tennessee, Missouri and Alabama, a dearth of shots in urban areas with the greatest number of health care workers has led senior citizens to snap up appointments hours from their homes. The result is a hodgepodge of approaches that can look like the exact opposite of equity, where those most likely to be vaccinated are people with the savvy and means to search out a shot and travel to wherever it is.

“It’s really, really flawed,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, who noted there are even vaccine hunters who will find a dose for money. “Ideally, allocations would meet the population’s needs.”

With little more than general guidance from the federal government, states have taken it upon themselves to decide what it means to distribute the vaccine fairly and reach vulnerable populations.

Tennessee, like many states, has divvied up doses based primarily on county population, not on how many residents belong to eligible groups—such as health care workers. The Tennessee health commissioner has defended the allocation as the “most equitable,” but the approach has also exposed yet another layer of haves and have-nots as the vaccine rollout accelerates.

In Oregon, the issue led state officials to pause dose deliveries in some rural areas that had finished inoculating their health care workers while clinics elsewhere, including the Portland metro area, caught up. The dust-up last month prompted an angry response, with some state GOP lawmakers accusing the Democratic governor of playing favorites with the urban dwellers who elected her.

Public health leaders in Morrow County, a farming region in northeastern Oregon with one of the highest COVID-19 infection rates, said they had to delay two vaccine clinics because of the state’s decision. Other rural counties delayed vaccines for seniors.

States face plenty of challenges. Rural counties are less likely to have the deep-freeze equipment necessary to store Pfizer vaccines. Health care workers are often concentrated in big cities. And rural counties were particularly hard hit by COVID-19 in many states, but their residents are among the most likely to say they’re “definitely not” going to get vaccinated, according to recent Kaiser Family Foundation polling.

Adalja said most of these complications were foreseeable and could have been avoided with proper planning and funding.

“There are people who know how to do this,” he said. “They’re just not in charge of it.”

In Missouri, where Facebook groups have emerged with postings about appointment availabilities in rural areas, state Senate Minority Leader John Rizzo, a Democrat from the Kansas City suburb of Independence, cited a need to direct more vaccine to urban areas.

The criticism drew an angry rebuke from Republican Gov. Mike Parson, who said vaccine distribution has been proportional to the population and critics are using “cherry-picked” data.

“There is no division between rural and urban Missouri,” Parson said during his weekly COVID-19 update last week.

In Republican-led Tennessee, Health Commissioner Lisa Piercey notes that the Trump administration deemed the state’s plan among the nation’s most equitable. Extra doses go to 35 counties with a high social vulnerability index score—many small and rural, but also Shelby County, which includes Memphis, with a large Black population.

Last week, state officials revealed some 2,400 doses had been wasted in Shelby County over the past month due to miscommunication and insufficient record-keeping. The county also built up nearly 30,000 excessive doses in its inventory. The situation caused the Centers for Disease Control and Prevention to investigate and the county health director to resign.

In Nashville, Democratic Mayor John Cooper says the fact that city residents can get shots elsewhere is a positive, even if the road trips are “a little bit of a pain.”


“I’m grateful that other counties have not said, ‘Oh my gosh, you have to be a resident of this county always to get the vaccine,'” Cooper said.

Nashville educators Jennifer Simon and Jessica Morris took sick days last week to make the four-hour round-trip to tiny Van Buren County, population less than 6,000.

They got their first shots there in January, when Republican Gov. Bill Lee was pushing Nashville and Memphis area schools to return to in-person classes. Republican lawmakers even threatened to pull funding from districts that remained online.

In-person classes started a couple weeks ago, but the city only began vaccinating teachers last week.

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Timing, Ethics Factor Into COVID Vaccine Trial With Minors

NEW YORK (Reuters Health) – As manufacturers of COVID-19 vaccines consider when and how to enroll minors into clinical trials, several factors such as timing and ethics should be considered, according to a team of pediatricians and bioethics specialists.

Starting too soon can expose minors to research risks, but waiting too long could prolong the pandemic and hold back vital vaccines for children and their families, the team writes in Pediatrics.

“In standard cases, trials don’t enroll minors until found to be safe and efficacious in adults, but in the case of COVID-19 vaccines, that could delay an effective response to the pandemic by six months to two years,” said senior author Dr. David Wendler of the National Institute of Health’s Department of Bioethics in Bethesda, Maryland.

“Our view is that vaccine trials tend to be much larger and can show safety data,” he told Reuters Health by phone. “We have so much safety data that it could be justifiable to enroll kids.”

Dr. Wendler and colleagues proposed recommendations for when and how to enroll minors in COVID-19-vaccine trials based on several factors. Although most infected children develop no or only mild symptoms, they write, those from racial and ethnic minority groups and those who have disabilities or underlying health conditions can experience severe illness and develop a multi-system inflammatory syndrome in children (MIS-C).

More than 1,000 children have developed the syndrome in the U.S., and more than 250 children have died from COVID-19, which is higher than the 188 minors who died during the most recent flu season.

The pandemic has also created significant social and personal harm for minors due to the closure of schools, daycare centers and extracurricular activities, the authors write. School-aged children haven’t received the educational and social benefits of in-person interactions, as well as the food, safety and care that schools and programs offer many children. Overall, a safe and effective vaccine would benefit minors, their families and society, they write.

“With careful planning, it’s possible for research to enroll minors in a way that is ethical and can speed the process to find a vaccine to end the pandemic,” Dr. Wendler said.

Importantly, Dr. Wendler and colleagues write, minors can’t provide informed consent, so it’s advisable to enroll children after clinical trials show sufficient safety and efficacy data in adults.

With the current COVID-19-vaccine trials, the approach could be to enroll minors after sufficient safety data in adults but before the evidence of efficacy, which should start with children who are most similar to the adults enrolled in the trials. Researchers should pay attention to the groups that were included or excluded in the adult trials and first enroll older adolescents who are similar to adults physiologically.

To further minimize risks, enrollment should begin with a small number of older, healthy adolescents, the authors suggest. If no safety concerns are identified, trials can proceed with a larger group of older adolescents and then include younger minors.

The most challenging group, ethically, is younger children who may not understand the clinical trial and minors with health conditions that put them at an increased risk for COVID-19 complications. These groups shouldn’t be enrolled until enough safety data exists.

When beginning clinical trials in children, vaccine companies and sponsors should also form community partnerships to ensure that participants reflect the geographic and demographic diversity of those affected by the pandemic, the authors write.

Partnerships can bolster recruitment, address community concerns and create a fair selection process when there are more interested participants than slots available. Community groups may also help build public trust in the research process, which makes it more likely that both children and adults will take a vaccine when one is available.

“Children are really suffering during the COVID-19 pandemic,” said Dr. Ed Anderson of Emory University School of Medicine in Atlanta, Georgia. Dr. Anderson, who wasn’t involved with this paper, has written about the benefits of enrolling children in COVID-19-vaccine trials.

“We ought to ensure that we do all that we can do to advance vaccine options for them quickly and safely,” he told Reuters Health by email.

SOURCE: https://bit.ly/3qP4jiS Pediatrics, online February 23, 2021.

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FDA issues EUA for third COVID-19 vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," said Acting FDA Commissioner Janet Woodcock, M.D.

"The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency's rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization."

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine's known and potential benefits outweigh its known and potential risks, supporting the company's request for the vaccine's use in people 18 years of age and older. In making this determination, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive "spike" protein of the SARS-CoV-2 virus.

While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness.

After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

After a thorough analysis of the data, the FDA's scientists and physicians have determined that the vaccine meets the FDA's expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use. With today's authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA's unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19."

Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research, Food and Drug Administration

FDA evaluation of available safety data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S.

The participants, 21,895 of who received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

FDA evaluation of available effectiveness data

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine.

Among these participants, 19,630 received the vaccine and 19,691 received a saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period.

Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group.

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue a EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of a EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under a EUA is not approved.

In determining whether to issue a EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency.

Once a manufacturer submits a EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of the Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials.

The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under a EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated.

The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Source:

Food and Drug Administration

Posted in: Disease/Infection News | Healthcare News | Pharmaceutical News

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A Patchwork: Europe and COVID-19 Vaccination Passports

(Reuters) – European Union leaders moved closer on Thursday to an agreement on certificates showing that citizens have been vaccinated against COVID-19, a move that could revive international travel and save this summer’s holiday season.

Some countries want an EU-wide approach instead of a patchwork of national schemes that in many cases are not intended to serve as travel documents. Halfway through a summit of leaders on the pandemic, officials said “convergence on a harmonised approach” to certificates was emerging.

Here’s where several EU member states and other European countries stand on vaccination certificates:

BETTER TOGETHER

GREECE has led calls for an EU-wide vaccine certificate to open up summer tourism. It has reached an agreement with Israel, which has launched a digital “Green Pass”, to ease travel for those with proof of vaccination. It issues certificates for people who have had twin shots.

Athens is in talks with Britain about a similar agreement, but its tourism minister was quoted as saying on Thursday that even unvaccinated Britons could visit the country.

SPAIN, AUSTRIA and BULGARIA also support a common EU approach. The government in Vienna says that, if there is no agreement at EU level by the spring, it will implement its own plan.

DOING THEIR OWN THING

DENMARK plans to launch a digital passport to document a traveller’s vaccination status, designed to be compatible with any future EU-wide scheme. SWEDEN plans a similar digital passport by summer, assuming an international standard is in place by then, as does FINLAND.

HUNGARY has announced that from March 1 it will issue a vaccination passport in the form of a card to citizens who have had the vaccine or have immunity after recovering from COVID-19. A decision about possible waivers from coronavirus restrictions will be taken later. People carrying the immunity passport will not have to go into quarantine.

RUSSIAN President Vladimir Putin ordered his government in January to consider issuing certificates to those who had been inoculated with domestic vaccines against COVID-19 for overseas travels.

THINKING ABOUT IT

BRITAIN is reviewing how COVID-19 status certificates could help reopen the economy. It will consider a system allowing vaccinated individuals to travel abroad more freely once more is known about the efficacy of vaccines against COVID-19 variants. The UK is working with the World Health Organization and other countries on an international framework for travel.

PORTUGAL is considering various options to resurrect the travel sector, but has cautioned that an EU-wide passport could lead to “some constraints” given delays in vaccinations.

WE HAVE OUR DOUBTS

GERMANY, which has restricted travel from neighbours with high rates of infection, is still in the early stages of debating the idea of vaccination certificates. There are widespread concerns that these could result in discrimination against those who choose not to be vaccinated.

ROMANIAN President Klaus Iohannis has said an EU vaccination passport would be divisive, splitting Europe between those who have been vaccinated and those who have not.

NO PLANS YET

POLAND has introduced a special QR code via its mObywatel app that can be scanned to confirm a user has been fully vaccinated, meaning they have received two doses. It has not yet said if it will introduce a specific vaccination “passport”.

FRANCE has not revealed any plans for a vaccination passport of its own, though travel industry lobbies and some opposition politicians have been pressing for such a scheme. ITALY does not have a national vaccination passport scheme.

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In Boost for COVID-19 Battle, Pfizer Vaccine Found 94% Effective in Real World

JERUSALEM (Reuters) – The first big real-world study of the Pfizer/BioNTech vaccine to be independently reviewed shows the shot is highly effective at preventing COVID-19, in a potentially landmark moment for countries desperate to end lockdowns and reopen economies.

Up until now, most data on the efficacy of COVID-19 vaccines has come under controlled conditions in clinical trials, leaving an element of uncertainty over how results would translate into the real world.

The research in Israel – two months into one of the world’s fastest rollouts, providing a rich source of data – showed two doses of the Pfizer shot cut symptomatic COVID-19 cases by 94% across all age groups, and severe illnesses by nearly as much.

The study of about 1.2 million people also showed a single shot was 57% effective in protecting against symptomatic infections after two weeks, according to the report published in the New England Journal of Medicine on Wednesday.

The results of the study for the Clalit Research Institute were close to those in clinical trials last year which found two doses were found to be 95% effective.

“We were surprised because we expected that in the real-world setting, where cold chain is not maintained perfectly and the population is older and sicker, that you will not get as good results as you got in the controlled clinical trials,” senior study author Ran Balicer told Reuters. “But we did and the vaccine worked as well in the real world.”

“We have shown the vaccine to be as effective in very different sub-groups, in the young and in the old in those with no co-morbidities and in those with few co-morbidities,” he added.

The study also suggests the vaccine, developed by U.S drugmaker Pfizer and Germany’s BioNTech, is effective against the coronavirus variant first identified in the UK. Researchers said they could not provide a specific level of efficacy, but the variant was the dominant version of the virus in Israel at the time of the study.

The research did not shed light on how the Pfizer shot will fare against another variant, now dominant in South Africa, that has been shown in lab experiments and trials to reduce the efficacy of current vaccines.

‘THIS IS MORE GREAT NEWS’

Of the nine million people in Israel, a nation with universal healthcare, nearly half have received a first dose, and a third have received both doses since the rollout began on Dec. 19.

This made the country a prime location for a real-world study into the vaccine’s ability to stem the pandemic, along with its advanced data capabilities.

The study examined about 600,000 vaccinated people against the same sized control group of unvaccinated people. Researchers at Harvard T.H. Chan School of Public Health, Harvard Medical School and Boston Children’s Hospital also collaborated.

“This is more great news, confirming that the vaccine is around 90% effective at preventing documented infection of any degree of severity from 7 days after the second dose,” said Peter English, a British government consultant in communicable disease control.

“Previous recently studied papers from Israel were observational studies. This one used an experimental design known as a case-control study … giving greater confidence that differences between the groups are due to their vaccination status, and not to some other factor.”

The study published on Wednesday was the first analysis of a national COVID-19 vaccination strategy to be peer-reviewed. It also offered a more detailed look at how the vaccine was faring at weekly intervals, while matching people who received the shot to unvaccinated individuals with similar medical histories, sex, age and geographical characteristics.

Other research centres in Israel, including the Weizmann Institute of Science and the Israel Institute of Technology have shared several studies in recent weeks that show the vaccine to be effective.

At least three studies out of Israel have also suggested the vaccine can reduce coronavirus transmission, but the researchers have cautioned that wider studies must be conducted in order to establish clear-cut conclusions.

GOT YOUR IMMUNITY PASS?

The Weizmann Institute’s latest data shows a dramatic drop in illness – which began this month with the first age group vaccinated, the over-60s – has now extended to the two subsequent groups to have completed both doses.

As infections have fallen in Israel, the country has eased its third national lockdown and reopened swathes of its economy including malls, shops, schools and many workplaces in the past two weeks.

Recreational venues such as theatres, gyms and hotels opened on Sunday, but are open only to those deemed immune – holders of a “Green Pass”, a health ministry document available for download only by people seven days after their second dose or people who have recovered from COVID-19.

On Wednesday, Tel Aviv held one of the country’s first live concerts after months of gatherings being banned under coronavirus restrictions.

“This is so exciting, we are really so happy to be here today. It’s unbelievable after one year of staying at home, it’s great to be out to see some culture,” said 60-year-old Gabi Shamir as she took her seat at the open-air show.

Still, the vaccine’s efficacy does not mean the country will be pandemic free any time soon. Like elsewhere in the world, a large proportion of the population are under 16 – about a third in Israel – meaning that they cannot yet get vaccinated as there have not been clinical trial results for children.

“This is definitely not the end of the pandemic,” said Eran Kopel, an epidemiologist at Tel Aviv University. “Once there is a safe vaccine for the children in Israel and all over the world we can then start to say that we could be approaching herd immunity.”

SOUREC: https://bit.ly/3utMHLJ The New England Journal of Medicine, online February 24, 2021.

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$52 Million Campaign to Push COVID Vaccinations

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The Ad Council and COVID Collaborative launched a campaign on Thursday to encourage Americans to get a COVID-19 vaccine when one is available for them, marking one of the largest public education efforts in the U.S.

More than 300 major brands, media companies, community-based groups, faith leaders and medical experts are championing the campaign. Adobe, Disney, Facebook, Google, LinkedIn, Snapchat, Spotify, Twitter, Verizon, and YouTube have put their support behind it, as well as the NAACP, NBCUniversal, Telemundo, UnidosUS, ViacomCBS, and the Black Information Network.

The campaign emphasizes the message “It’s Up To You” to get vaccinated. Created in partnership with the CDC, the platforms at GetVaccineAnswers.org (and DeTiDepende.org in Spanish) provide the latest information about COVID-19 vaccines and answer frequent questions that people may have. Content is available in seven languages: English, Spanish, Simplified Chinese, Korean, Russian, Haitian Creole, and Vietnamese.

“We’re listening to America’s top questions, understanding their concerns, and working to educate and empower people across the country — particularly communities of color who have been disproportionately impacted by the pandemic — so they can make an informed choice about vaccination for themselves and for their families,” Lisa Sherman, president and CEO of the Ad Council, said in a statement.

The Ad Council has launched a series of national coronavirus public service announcements during the past year, including the Mask Up America campaign, and messages about social distancing and fighting loneliness during the pandemic.

The campaign, which is funded by $52 million in private donations, is aimed at building vaccine confidence and clearing up questions about how safe COVID-19 vaccines are and how well they work. About 71% of Americans say they’re willing to get a vaccine, according to a Gallup poll done at the end of January, including 9% who said they already received at least one dose of a vaccine.

At the same time, about 40% of Americans still haven’t made a firm decision about vaccination, according to an Ad Council/Ipsos Public Affairs poll done this month. The poll also showed that only 40% of people in Black and Hispanic communities said they have enough information to make a decision about getting a vaccine, as compared with 60% of the overall population. In addition, about 75% of people who are hesitant about getting a vaccine said they want more information to address their questions, even if they’re not yet eligible to receive a vaccine.

Getting more people vaccinated will get the country closer to herd immunity, and closer to people returning to their pre-pandemic routines. According to CDC data, white Americans have received 60.4% of vaccines, compared to 5.4% for Black Americans and 11.5% for Hispanic Americans. More than 66.5 million doses of the vaccine have been given so far.

“Just as we are taking action to address the inequities this pandemic laid bare, we need a concerted approach to bring an end to the pandemic and to leverage the lessons learned during COVID-19 to achieve optimal health for all,” says Rochelle Walensky, MD, director of the CDC.

The CDC brand will be on several parts of the campaign, and officials from the CDC and the Department of Health and Human Services will provide scientific guidance throughout the initiative.

“Our goal is to help the Black community get the facts, despite their inherent distrust in the government and medical community, and help them make an informed decision about COVID-19 vaccines,”  Kelli Richardson Lawson, CEO of JOY Collective, which created content for the campaign, said in a statement.

The campaign will engage the faith community as well through the National Association of Evangelicals, the National Latino Evangelical Coalition, and more than 20 influential leaders across U.S. faith communities.

The campaign will begin to appear nationwide this week on broadcast TV, digital platforms, radio, and social media.

More initiatives will roll out over the coming weeks.

Sources:

Ad Council: “It’s Up To You,” “Mask Up America.”

Gallup: “Two-Thirds of Americans Not Satisfied With Vaccine Rollout.”

Hispanicize: “DeTiDepende Special Edition.”

Morbidity and Mortality Report: “Demographic Characteristics of Persons Vaccinated During the First Month of the COVID-19 Vaccination Program — United States, December 24, 2020-January 14, 2021.”

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COVID-19 vaccine acceptance falling globally and in the U.S., survey finds

vaccine

The percentage of people globally who say they will get a COVID-19 vaccine has fallen in recent weeks, even as tens of millions of doses have been administered around the world, new survey data suggest.

The Johns Hopkins Center for Communication Programs, along with MIT, Facebook, and WHO, have been overseeing a global COVID behavior survey since July 2020 from nearly 1.7 million participants across 67 countries. The most recent data, drawn from more than 86,000 participants in 23 countries including the U.S., were collected in the two weeks ending February 1. The Center for Communication Programs is based at the Johns Hopkins Bloomberg School of Public Health.

After a slight increase to 66 percent of people saying they would get a COVID-19 vaccine at the beginning of January 2021, the average acceptance level across the 23 countries in this analysis fell to 63 percent. This overall decline comes amidst increased focus and media discussion on the rollout and access to COVID-19 vaccines. Broken down by country, the latest survey found that, in the final two weeks of January, vaccine acceptance declined in seven countries, remained similar in another seven, and rose in nine more.

Since March 2020, when WHO declared COVID-19 a pandemic, more than 112 million cases have been recorded and nearly 2.5 million people have died from it, according to Johns Hopkins University. More than 500,000 people have died from COVID-19 in the United States, the largest number of deaths in any country.

“We had hoped we would find that acceptance of COVID vaccines was on the rise in more countries, since vaccination is a critical part of ending the pandemic,” says CCP’s executive director Susan Krenn. “This means we have more work to do in helping people understand why getting vaccinated is so crucial to helping them, their families, and their communities.”

A key point to communicate is that a large percentage of people in a community need to be vaccinated in order to reach herd immunity, the level at which the spread of SARS-CoV-2—the virus that causes COVID-19—becomes difficult. Herd immunity levels vary depending on the infectiousness of a disease. Dr. Anthony Fauci, director the National Institute of Allergy and Infectious Diseases, has estimated that 70 to 85 percent of Americans need to be vaccinated to reach herd immunity for COVID-19. That threshold is much higher than the percentage of people in many countries reporting that they would be willing to get a vaccine.

The surveys leveraged Facebook’s reach of more than two billion global users, an average of 112,000 of whom participated in surveys roughly every 14 to 17 days since July. The questions have been about COVID-19 prevention behaviors such as mask wearing and social distancing, vaccine acceptance and trusted COVID influencers. This work has informed both global and national COVID-19 policies, and in the coming month the survey will evolve to include more countries and richer data to better describe global efforts to address the pandemic.

Of five countries in the Americas, the latest data found, only the United States saw a decline in vaccine acceptance in late January (from 69 percent to 65 percent). The other four countries— Mexico, Argentina, Brazil, and Colombia—saw an increase of five percentage points in vaccine acceptance. Argentina saw much higher acceptance rates among certain demographics. For example, in the most recent survey, acceptance rates in Argentina are higher among older (+18 percent), college educated (+12 percent), urban residents (+20 percent), and men (+5 percent) than they were two weeks earlier.    

The survey found that reported vaccine acceptance rates in European countries remained constant, with Italy and the United Kingdom well into the range of achieving herd immunity. Some countries (Italy, the UK, and Germany) have very low rates of reported non-acceptance (8 percent, 10 percent, and 13 percent, respectively). By contrast, respondents in Turkey and France are consistently among the lowest reported rates of vaccine acceptance within the 23 countries surveyed in this study: 24 percent and 56 percent, respectively.  

After a recent dip, acceptance levels in Nigeria are beginning to rise. Gender differences there continue to exist among participants, but since the last data collection period women’s acceptance rates increased 4 percentage points from 51 percent to 55 percent.

Along with the new data on vaccine acceptance rates, CCP released another wave of data about other COVID-19 prevention behaviors for the last two weeks in January. From the first survey in July, reported handwashing in the United States is down in every group except rural residents. Over the same period, reported mask wearing and physical distancing are up in the U.S. And while a smaller percentage of Americans report they have trust in scientists, they are still the most trusted sources of COVID-19 information.

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