Category: Covid-19 Vaccine

Data should be fully and immediately available for public scrutiny

In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234

The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56 Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency.

Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the publicand are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions.

Pfizers pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).

The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data may be available with publication of the final study results in 2022.18 Datasets will be available upon request and subject to review once the trial is complete, which has an estimated primary completion date of 27 October 2022 (NCT04470427).

As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, timelines vary per request and can take up to a year upon full submission of the request.20

Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regenerons phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing will be considered. For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.

We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.

Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agencys former executive director and senior medical officer, relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ... Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).22

Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizers vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDAs offer and ordered the data be released at a rate of 55000 pages a month. The data are to be made available on the requesting organisations website (phmpt.org).

In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment.2425 Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021,2425 and missing appendices may be accessible through freedom of information requests.

Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizers vaccine; other manufacturers data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers.

Like the FDA, and unlike its Canadian and European counterparts, the UKs regulatorthe Medicines and Healthcare Products Regulatory Agencydoes not proactively release clinical trial documents, and it has also stopped posting information released in response to freedom of information requests on its website.26

As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details27 such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2.28 Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.29

Big pharma is the least trusted industry.30 At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud.31 Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.32

The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust in the system, with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering peoples legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.

Twelve years ago we called for the immediate release of raw data from clinical trials.1 We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions. There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination. The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts.

Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.33 The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.

Competing interests: We have read and understood BMJ policy on declaration of interests and declare that The BMJ is a co-founder of the AllTrials campaign. PD was one of the Cochrane reviewers studying influenza antivirals beginning in 2009, who campaigned for access to data. He also helped organise the Coalition Advocating for Adequately Licensed Medicines (CAALM), which formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). PD is also a member of Public Health and Medical Professionals for Transparency, which has sued the FDA to obtain the Pfizer covid-19 vaccine data. The views and opinions do not necessarily reflect the official policy or position of the University of Maryland.

Provenance and peer review: Commissioned; externally peer reviewed.

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Covid-19 vaccines and treatments: we must have raw data, now - The BMJ

Seven businesses filed suit against the city of Minneapolis and Mayor Jacob Frey on Thursday over a new rule requiring customers to show proof they have received a full series of a COVID-19 vaccine or tested negative for the virus within 72 hours before entering bars and restaurants.

The rule went into effect on Wednesday in Minneapolis and applies to all businesses that serve food and beverages that are consumed on-site including restaurants, bars and concert venues. St. Paul Mayor Melvin Carter issued an identical mandate.

The lawsuit was filed by owners of the Gay 90s, Sneaky Petes, Smack Shack, Urban Forage, Wild Gregs Saloon, a Jimmy Johns franchisee and Bunkers Music Bar & Grill, who say the requirement is a misuse of mayoral power and puts an unfair burden on them.

Minneapolis bars and restaurants are being used as pawns to further Mayor Freys agenda of pushing for and convincing the public to get vaccinated, the complaint reads. Whether the end being sought is noble, the scheme is forcing restaurants and bars to lose additional patrons and business.

The mayors of Minneapolis and St. Paul said they needed to implement the requirement to deal with a surge in COVID-19 cases driven by the highly contagious omicron variant. But the business owners argue there is currently no emergency that warrants such a requirement.

They point to the fact that Gov. Tim Walz allowed a statewide peacetime emergency to expire in July 2021.

COVID-19 has been a pandemic for over nearly [sic] two years, and while certainly tragic in its effects upon society during that time, developments have occurred reducing its emergent nature, the complaint reads.

The business owners are asking the court to declare the mandate invalid and prohibit the city from enforcing it.

Other cities across the country, including New York, San Francisco and Chicago, have implemented similar mandates despite also facing legal challenges.

Some Twin Cities businesses have already been requiring patrons to show their vaccination cards or a negative COVID-19 test, including First Avenue, the Guthrie, Fair State Brewing and others.

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Restaurants sue Minneapolis over requirement that customers have COVID-19 vaccine or negative test - Minnesota Reformer

Saved on the Siuslaw

On Dec. 31, 2021, I was thrown into a very cold Siuslaw River when my drift boat flipped over on me while attempting to land a steelhead.

The outpouring of kindness from people, many of whom I didn't know, has been overwhelming and humbling.

I would like to thank the young man who helped me onto shore and up the steep bank to the road. Unfortunately, I was unable to get his name, but won't forget what he did for me.

Also, I would like to thank the state trooper from Florence and the Veneta EMS for administering first aid to my injuries.

This experience has reinforced to me how lucky we are in this country to have so many caring and helpful people.

One last comment wear your life jacket. It helped save me.

Steve Tenhaeff, Springfield

One hears over and over how unhappy Oregonians are with the economy, COVID-19 restrictions, forest fires, crime and issue after issue. And yet as an old adage goes, the definition of insanity is repeating the same thing over and over again and expecting different results. Voters elected John Kitzhaber, then Kate Brown and then re-elected Brown. In 2022, its time to elect a governor again. Maybe its time to try something different. Just saying.

Stan Kluth, Eugene

Nick Kristof is barking up the wrong tree.

Since he feels rules don't apply to him, instead of trying to hoodwink Oregon folks he needs to apply for a job in the Trump organization. That way the two of them can deceive, fool, connive, pretend, promise but not deliver and in other ways carry on the tradition of Donald Trump. What a great team they would make.

Barry C. Smith, Eugene

The other night my husband and I watched the old movie Silverado. In it, when Danny Glovers character is refused a drink in the saloon because hes Black, he says, It aint right. All the white guys sit quietly and watch him get beat up and thrown out. It aint right, but it works for white people.

We know it aint right that an overwhelmingly white and male mob sought to take back by force what they could not accomplish in a peaceful and democratically conducted election.

We know it aint right to refuse to turn over records to a deadly riot.

We also know that when you cast a ballot in another state you are no longer a resident of Oregon.

Democrats in red states are fighting tooth and nail for the right to vote. Meanwhile, Democrats in Oregon live in a blue bubble. Bending the rules in Oregon muddies the water. You cant claim to live in one state, then vote in another. Isnt that voter fraud? If Nicholas Kristof wants to run for governor of Oregon, he wont get my vote because it aint right. I wont compromise the argument for voting rights elsewhere. Plain and simple.

Margaret Moore, Eugene

Its ironic that in this era when Republicans are doing all they can to restrict voting access and transform elections to selections, Oregons Democratic secretary of state chose to deny voters the opportunity to vote for Oregon native Nick Kristof.Her decision, if allowed to stand, removes the biggest obstacle to electoral success for other career Democrats who work alongside her in the Capitol Building.

Kristof happens to be a political outsider, the kind that Oregon could really use now. Fortunately, the Oregon Supreme Court recognizes that determinations of ballot eligibility fall squarely within the domain of the judicial branch of government.

Retired Supreme Court Justice William Riggs wrote a legal opinion two weeks ago on this topic and concluded that Kristof is indeed an Oregon resident, even though his job required him to live in other places around the world during his lengthy, brilliant career as an acclaimed journalist and humanitarian.Three former Oregon secretaries of state agree with Riggs.

I attended law school with current and former members of the Oregon Supreme Court, and unlike the U.S. Supreme Court (and our secretary of state), I know they will decide Kristofs eligibility based on the facts and the law.

Dan Neal, Eugene

I watched the videos of the people attacking the U.S. Capitol as they shoved and stole and yelled. I know them. They are my neighbors, townspeople, sports fans. Many are my age raised to revere democracy and freedom. I want to shout at them, "Knock it off!" If you want to be owned by Trump, be owned by Trump.

If you want to serve him and adore him, then serve him and adore him. Give up your freedom if you want. This is America. But don't try to force me to give up mine. I love my freedom from dictatorship. This is America for me, too. Go serve your false god, but leave me alone.

Candy Neville, Eugene

I was in a local market today and there were three customers not wearing masks. I was shocked to see this as I believe that mask wearing indoors is a state mandate.

I asked an employee about it and was told they offer masks to customers, but if they refuse, the customers are allowed to shop unmasked. Apparently, weve entered a new phase where the people claiming their individual rights for going unmasked have acted in such threatening and violent ways that store owners have given up.

How dare these self-centered individuals put others in peril not just by threatening someone who asks them to follow the rules but also by subjecting every stranger they come in contact with? Then I thought about how my individual rights are curtailed by other laws protecting our community. For instance, sometimes Im in a hurry but have to stop for a stop sign. That silly law infringes on my right to drive down the road unimpeded. Why should I have to inconvenience myself for the safety of others?

Wearing a mask to protect yourself and others is so easy to do why make such a big deal out of it?

Teresa Dobles, Eugene

Steve Mozena is right. We must demand return to normal life, as urged back in October 2020 in theGreat Barrington Declarationby three distinguished Harvard, Stanford and Oxford epidemiologists, signed by 61,678 health professionals and scientists worldwide.

Yet seemingly entranced, media-terrorized citizens mask themselves in open air and their own cars, oblivious toCOVID-19 case recovery rates over 99% for age groups under 55, with almost all fatalitiesinvolving serious co-morbiditiesmaking cause-of-death uncertain. TheNuremberg Coderequires informed consent for all medical procedures, including risk-benefit comparison. With little fatality risk there is little benefit and no legal justification underFDA regulationsforexperimental lipid-mRNAinjections with adverse events documented in CDCsOpen VAERS*including 21,382 deaths, 36,758 permanent disabilities and 39,678 heart and vascular emergenciesthrough December 2021 that havent spared the young.

Moreover, case identifications arehighly questionableand effective early treatments have beensuppressedby public health bureaucrats, causing thousands of needless deaths among co-morbid elderly. Lockdown measures have caused appallingdestruction of Main Street economiesand publicwealth transferto billionaires and multi-national corporations.Preventing normal human interactions causes severesocial, psychologicalandhealthimpacts.SCOTUS has rightlystayed vaccine mandates.

This begs criminal investigation.

Jack Dresser, Springfield

*Editor's note:Should you visit openvaers.com/covid-data, read the CDC Disclaimer.

It looks to me the Eugene Police Department is learning from past fatal mistakes when responding to the mentally ill.

I recently called 911 when a friend threatened suicide with a knife. Instead of sending CAHOOTS, EPD sent about a half-dozen armed policemen, so I feared the worst. However, EPD also sent a negotiator, who was able to talk my friend into dropping the knife and letting them take him to the hospital.

I was impressed with the kindness and compassion shown by the whole group. Kudos to the EPD.

Joella Ewing, Eugene

How can we move forward with such division in our country and government?What do we all have in common?

We all love this country and worry about the future.Some fear oppressed minorities will win control and treat white Americans as badly as they have been treated.Others fear a future in which armed, ultra-right extremists, like those that stormed the Capitol on Jan. 6, 2021, will overturn our democracy and terrorize any who oppose them.But we all worry about the future of this wonderful country.

Rage at the other side might feel good, but we must stop fearing, hating and loathing each other.We must turn off Fox and Friends, put away our guns and listen to and respect each other.There is no path back to the America made great by the shared suffering and sacrifice of our parents and grandparents.Anyone who tells you so is lying and trying to make a fool out of you.

We can only make America great by overcoming fear. We must listen to andwork with those different than ourselves regardless of income level, race, religion, creed, gender identification, sexual orientation or place of national origin.

Donald M. Brasted-Maki, Eugene

I read with sadness The Register-Guard'sdecision to stop publication of its print newspaper on Saturdaybeginning on March 24. I don't know if this is just the beginning of an overall halt in delivery services.

First, newspaper size was reduced, then delivery was halted on importantholidays, and now once a week there will be no print newspaper. As we all know, print publications have been facing a multitude of challenges, including higher operating costs, competition from online media and decreased readership.

Even though The Register-Guard claims to have ample online offerings, not everyone, including myself, wants the eye strain or sleep disruption that comes from constant exposure to bright screens and prefer tangible print instead. This is not to mention potentially alienating a large customer base for print publications, the elderly, some of whom may struggle with accessing the online version. The R-G needs to focus on retaining its existing customer base, not further driving them away in what already appears to be a downwarddeath-spiral.

Erica Lyon, Eugene

Somebody sent me a free sample copy of The Epoch Times. After paging through it, I noticed that there are no advertisers, except for ads for other reading materials produced by The Epoch Times. It made me wonder how it can afford to pay its workers without advertising revenue. The stories sound like they were written my brother in Ohio or my brother-in-law in Nevada.

Does it actually hire reporters who go into the field, or do its writers just read what other newspapers report, then make up their own stories?

I would have written to The Epoch Times, but there is no letters-to-the-editor section in The Epoch Times.

Thank you, Register-Guard, for your quality journalism. I dont always agree with the opinions, but at least I can trust the stories.

Margaret Moore, Eugene

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Letters to the editor: Nicholas Kristof, the COVID-19 vaccine and a river rescue - The Register-Guard

Its been more than two months since the Centers for Disease Control and Prevention (CDC) recommended Pfizers COVID-19 vaccine for children, ages 5-11, in the United States. We previously assessed pediatric vaccination uptake, finding that, after initial high demand, it had already slowed significantly. We also found a wide range in vaccination rates by state. Since that time, Omicron has become the dominant variant in the U.S. and COVID-19 cases, hospitalizations, and deaths are rising again.

Here, we provide an update on the vaccination status of 5-11 year-olds, through January 18, 2022. It is based on analysis of national and state-level vaccination data obtained from the CDCs Data Tracker (see methods below). Overall, we find that the number of first doses newly administered to 5-11 year-olds remains far below its early peak and although there was a slight uptick for a period in December, it has again declined. There also remains a large gap of 52 percentage points between the most vaccinated and least vaccinated states. Specific findings include:

More than two months following authorization of the COVID-19 vaccine for children ages 5-11, the vaccination rate for this group is quite low, and there is significant variation across the country, with a more than 50 percentage point gap between the highest and lowest ranking states among those having received at least one dose. This likely reflects a complicated interplay between the efforts made by state and county governments, schools, and pediatricians to vaccinate children, and the makeup of the citizenry itself and its interest in vaccination. With the highly transmissible Omicron variant surging across the U.S., the vaccine, which has proven very safe for children, offers the most effective protection against severe disease and hospitalization. In addition, while vaccination during the Omicron surge may not prevent all school disruptions, it does help to mitigate them. Identifying opportunities to reach parents and caregivers, many of whom have been reluctant to get their younger children vaccinated, with information about vaccination and providing multiple, accessible, avenues for pediatric vaccination, will continue to be important.

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Update on COVID-19 Vaccination of 5-11 Year Olds in the U.S. - Kaiser Family Foundation

Patrons must show proof of vaccination at many public indoor establishments in Washington, D.C., including restaurants, bars, gyms and entertainment venues.

The vaccine mandate went into effect Jan. 15 in an attempt to decrease the transmission of the Omicron variant of COVID-19 as cases reach record highs in the District. Patrons who are 12 years old and older must provide proof of at least one dose of the COVID-19 vaccine, and those who are 18 years old and older must also show a valid photo identification before entering establishments. Beginning Feb. 15, full vaccination, not including booster shots, will be required.

Retail establishments, grocery stores, houses of worship and health care facilities are among the locations where patrons do not have to show proof of vaccination.

About 68% of District residents are fully vaccinated and 89% of District residents are at least partially vaccinated, making them eligible to be indoors in vaccine-restricted public spaces.

Jos Espinal, marketing coordinator at El Centro, a popular Mexican restaurant in the Georgetown neighborhood, hopes that the vaccine mandate will ultimately increase business by making customers feel safer in public spaces.

I think most businesses will be able to adapt to the mandate, Espinal wrote in an email to The Hoya. I think a lot of patrons were similarly concerned about rising cases, so I think this will alleviate some of their concerns about going out.

Venues that serve alcohol and violate the vaccine mandate will face two warnings from the Alcoholic Beverage Regulation Administration, with third and fourth violations resulting in $1,000 and $2,000 fines. A fifth violation of the vaccination mandate will result in establishments facing the Alcoholic Beverage Regulation Administration, leading to the possible suspension of their liquor license.

The Big Board, a bar located in the H Street Corridor neighborhood, became the first establishment in the District to receive a verbal warning for not requiring proof of vaccination or posting appropriate signage. The bar came under scrutiny for a tweet last week stating that everyone is welcome despite the mandate.

Communication to patrons in advance of the vaccine mandates implementation made the transition easy and safe for entertainment venues, according to Jordan Silberman, general manager of Capital One Arena.

We had a great system in place to comply with the Mayor Bowsers vaccination mandate, Silberman wrote in an email to The Hoya. We proactively messaged to our guests about the new policy, instituted the use of the CLEAR Health Pass App (which we had previously used for some concerts last year), and had knowledgeable staff who were able to help fans quickly and safely into the arena.

Individuals can show proof of vaccination with an official Centers for Disease Control and Prevention (CDC) vaccination card, a digital photo of their vaccination card or a COVID-19 vaccination app, such as CLEAR. Individuals with medical or religious exemptions must bring proof of a negative COVID-19 test taken in the past 24 hours.

According to Zayan Baig (NHS 25), who lives in the Washington, D.C.-Maryland-Virginia area and visits the Georgetown neighborhood frequently even when not on campus, the vaccine mandate will help students feel comfortable when they leave campus, where the student vaccination rate is 98% and booster shots are required.

Even though we are in the greater D.C. area, I have some comfort knowing that within our Georgetown bubble, most everyone on campus is vaccinated and that should contribute to a little bit of herd immunity, at least on the campus level, Baig said in an interview with The Hoya. I personally have no problem with having to show vaccine cards, I think it helps with feeling a little bit safer.

The vaccine mandate should help keep employees, patrons and District residents safer, according to Espinal.There is always some challenge with new regulations, but our team has been so great at adapting to all the ups and downs of the past two years, Espinal wrote. Im confident that theyll be able to adapt to this change as well. Hopefully, this new change will help push DCs vaccination rate up.

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COVID-19 Vaccine Mandate In Effect in DC - Georgetown University The Hoya

One week after apparel company Carhartt Inc. declared it was keeping its Covid-19 vaccine mandate in place, the company defended its plans despite growing pushback from customers and on social media.

Some people said they would stop buying Carhartt products and said the company shouldnt be forcing its employees to choose between getting vaccinated and keeping their job. Other customers welcomed the companys mandate and thanked Carhartt for keeping their employees safe.

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Carhartt Stuck With Its Covid-19 Vaccine Mandate. The Backlash Ensued. - The Wall Street Journal

EUCLID, Ohio When looking at the Ohio Department of Healths COVID-19 dashboard, 63-year-old Tommy Daniels of Euclid looks back at December 4 as the day he became part of the statistic.

He was among the more than 250 new people who were hospitalized with COVID-19 each day during that week in Ohio.

I felt bad, he recalled. My whole body was down. I had trouble eating, smelling food and tasting it. I asked my doctor if I was going to die and he said he didnt know. So I broke down crying and I cried and I prayed.

For Daniels, his stay at the Cleveland Clinic only lasted two days, which he and his doctor credit to getting the COVID-19 vaccine in March.

I worry about what couldve happened to Tommy had he not had the vaccine, said Dr. Rachel Taliercio with the Cleveland Clinics Respiratory Institute. It was critical to him not only surviving the illness, but he survived COVID-19 and had a mild disease.

Daniels has struggled with COPD, a lung disease that runs in his family, for years. It forces him to carry around an oxygen machine.

Tommy has severe COPD, is dependent on oxygen, and takes a lot of medications to keep his condition under control, Dr. Taliercio said.

Photo provided by The Cleveland Clinic

Over the years, Daniels told News 5 he ended up needing to take three trips to intensive care because of COPD, which was part of the reason why he decided to get the COVID-19 vaccine.

Daniels is scheduled to receive his COVID-19 booster shot on Friday.

Go get those shots, he said. I thank God for helping me stay alive. I still have trouble breathing but I am not going to give up though.

Visit our Vaccinating Ohio page for the latest updates on Ohio's vaccination program, including links to sign up for a vaccine appointment, a map of nearby vaccination sites, a detailed breakdown of the state's current vaccine phase, and continuing local coverage of COVID-19 vaccines in Northeast Ohio.

Download the News 5 app for free for your Apple or Google device for the latest vaccine and COVID-19 news, and for limited and timely news alerts on vaccines, the COVID-19 pandemic, and other important local news and weather.

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63-year-old Euclid man with COPD credits COVID-19 vaccine with saving his life - News 5 Cleveland

A booster clinic for teens in Berkley, Mich., a suburb of Detroit, on Thursday.Credit...Emily Elconin for The New York Times

Booster shots of the vaccines made by Pfizer-BioNTech or Moderna were 90 percent effective at preventing Americans infected with the Omicron variant from ending up in the hospital, according to data published on Friday by the Centers for Disease Control and Prevention.

Booster shots also reduced the likelihood of a visit to an emergency department or urgent care clinic. The extra doses were most effective against infection and death among Americans aged 50 and older, the data showed.

Over all, the new data show that the vaccines were more protective against the Delta variant than against Omicron, which lab studies have found is partially able to sidestep the bodys immune response.

It is generally accepted that booster shots keep people from becoming infected, at least for a while. Data from Israel and other countries have also suggested that boosters can help prevent severe illness and hospitalization, especially in older adults.

Data from other countries have also shown significant benefit of getting the booster, but this is really showing it in the U.S., Akiko Iwasaki, an immunologist at Yale University, said of the figures released on Friday. These numbers should be very convincing.

On Thursday night, the C.D.C. published additional data showing that in December, unvaccinated Americans 50 years and older were about 45 times more likely to be hospitalized than those were vaccinated and got a third shot.

Yet less than 40 percent of fully vaccinated Americans who are eligible for a booster shot have received one.

Source: Centers for Disease Control and Prevention | Note: Line shows a seven-day average. Data not updated on some weekends and holidays. Includes the Johnson & Johnson vaccine as of March 5, 2021. The C.D.C., in collaboration with the states, sometimes revises data or reports a single-day large increase in vaccinations from previous dates, which can cause an irregular pattern in the daily reported figures.

Fridays results are based on three new studies led by the C.D.C. In one study, researchers analyzed hospitalizations and visits to emergency departments and urgent care clinics in 10 states from Aug. 26, 2021 to Jan. 5, 2022.

Vaccine effectiveness against hospitalization with the Omicron variant fell to just 57 percent in people who had received their second dose more than six months earlier, the authors found. A third shot restored that protection to 90 percent.

Its unclear whether protection from the boosters might also wane as it did after two shots, noted Natalie Dean, a biostatistician at Emory University.

We just have to recognize that all these estimates of Omicron third-dose protection are going to be people who are pretty recently boosted, she said. We do wonder the durability of boosters themselves.

When debating booster shot recommendations for all American adults, scientific advisers to the Food and Drug Administration and the C.D.C. repeatedly bemoaned the lack of booster shot data that was specific to the United States.

There are differences between Israel and the United States for example, in the way Israel defines severe illness that made it challenging to interpret the relevance of Israeli data for Americans, they said.

Some members of the Biden administration supported the use of booster doses even before the scientific advisers of the agencies had a chance to review the data from Israel. Federal health officials intensified their boosters-for-all campaign after the arrival of the Omicron variant.

The C.D.C. now recommends booster shots for everyone 12 years and older, five months after getting two doses of the mRNA vaccines made by Pfizer-BioNtech and Moderna, or two months after a single dose of the Johnson & Johnson vaccine.

The usefulness of booster shots in Americans younger than 50 was a topic of vigorous debate in the fall. Several experts argued at the time that third shots were unnecessary for younger adults because two doses of the vaccine were holding up well.

Some of those experts remained unconvinced by the new data.

It was clear even months ago that older adults and those with weakened immune systems would benefit from extra doses of the vaccine, said Dr. Paul Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia and a member of the F.D.A.s vaccine advisory committee.

But where is the evidence that a third dose benefits a healthy young person? he asked.

If youre trying to stop the spread of this virus, vaccinate the unvaccinated, he added. We keep trying to further protect the already protected.

But other experts changed their minds in favor of boosters because of the highly contagious Omicron variant. Even if two doses were enough to keep young people out of hospitals, they said, a third dose could limit virus spread by preventing infections.

Theyre both data-driven, legitimate positions, said John Moore, a virologist at Weill Cornell Medicine in New York. But at this point, the debate is over: We are using boosters in everyone, and thats whats happening.

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Covid-19, Omicron Variant and Vaccine News: Live Updates - The New York Times

In May 2021, nearly all, 98% to 99% of the covid deaths, were among the unvaccinated. Recent data shows those who are unvaccinated are 20 times more likely to die from COVID-19 as compared to the vaccinated.

Dr. Manoj Jain| Guest Columnist

Watch: Snow falls on Shelby Farms Park in Memphis

Mud Island is covered in snow after a winter storm moved through the Mid-South overnight.

Christine Tannous, Memphis Commercial Appeal

Have you ever wondered what you can do to save one life?

The answer is simple. Help get 300 to 500 people vaccinated.

How did I come to this conclusion? As an infectious disease doctor I am still seeing people die from Covid in the hospital. As an epidemiologist I can see upstream as to where and why they are coming and how we can prevent it.

So here is a back of an envelope calculation. In Tennessee, so far, we have had 2 million reported cases and over 20,000 deaths. So, for every 100 reported cases, one COVID-19 death occurs.

However, we know that all infections that occur are not reported. In fact, for every reported case there are 3 or 5 or higher number of infections. So, likely we have 300 infections or more in the community, leading to 100 reported cases which leads to 6 people being hospitalized and 1 person dying from COVID-19.

In May 2021, nearly all, 98% to 99% of the covid deaths, were among the unvaccinated. Recent data shows those who are unvaccinated are 20 times more likely to die from COVID-19 as compared to the vaccinated. In essence, we are experiencing an Omicron hospitalization and death epidemic of the unvaccinated.

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I am seeing this on the ground as an infectious disease doctor. I saw a 40 year old man, unvaccinated, infected with COVID-19 with no underlying health problems in the ICU struggling to breath. I did my research on the vaccine, I was just looking at the wrong websites. I wish I had gotten vaccinated. He said. He was lucky and lived to go home.

Another 44 year old, unvaccinated, Covid positive patient is on the ventilator for over a month and another passed away leaving behind three young children and his wife. There are many more like them. Each day in US nearly 1,600 unvaccinated people are dying from Covid.

So, if we want to save a life, we need to go upstream from the ICU beds, upstream from the hospitalizations, upstream from those who get COVID-19 infection to reach those in the community who are not vaccinated. We need to find them and help them understand the dire consequences of a poorly informed decision of not getting vaccinated.

They are our friends, family, neighbors, work colleagues, church members and fellow human beings. Being unvaccinated with the highly transmissible Omicron variant is a grave danger in the present circumstances.

Yet, if you convince 300 people to get vaccinated you are not just saving one life but averting 6 hospital admissions due to COVID-19. These admission take up hospital beds and health personnel resources leaving others without a hospital room for admission. A teenager with concussion may not get an ICU bed, a middle aged woman with abdominal pain and an inflammation in the appendix does not have a ready room to go to.

An elderly man with a heart attack and heart catheterization showing multiple blockages does not have an ICU bed post-op so surgery is delayed. Or a patient with uncontrolled diabetes has a foot ulcer which he neglects due to a busy emergency room and now the leg has turned gangrene and requires amputation.

The pandemic and the rapid spread of Omicron may not be preventable in the number of cases but our response with vaccination can prevent severe illness and death. One in every 388 people in America has died of COVID-19. Now, we need to reach out to others. So go and convince 300 unvaccinated people to get vaccinated and save one life.

They dont know it now, but they will thank you later.

Dr. Manoj Jain, an infectious disease physician in Memphis, is also a member of the City of Memphis-Shelby County Joint COVID Task Force.

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A year after COVID-19 vaccines came to U.S., they're still our best hope to end pandemic | Opinion - Commercial Appeal

A COVID-19 vaccination requirement notice on a McDonalds door. Mayor Michelle Wu launched a new policy, B Together, Jan.15 requiring proof of one dose of the COVID-19 vaccine for people aged 12 and older to enter certain indoor spaces. PHOTO BY MOHAN GE/DFP STAFF

Mayor Michelle Wus B Together policy a mandate requiring proof of one COVID-19 vaccine dose to enter certain indoor spaces in Boston came into effect Jan. 15 to help curb surging cases of COVID-19 in the City and encourage unvaccinated Bostonians to get vaccinated.

The initiative applies to indoor spaces like restaurants, gyms and entertainment facilities including movie theaters and concert venues.

We are working every day to end this pandemic, Wu said at the press conference. Todays launch of our B Together policy means that we are taking important steps on the policy side to close those gaps and continue protections for our workforce and for our residents.

Bostonians must show a digital image or physical copy of their CDC vaccination card, an image or printout of any official immunization record or other accepted COVID-19 vaccination verification apps when entering an indoor space, according to the Citys website.

The protocols instituted Saturday are part of the first phase of the B Together policy. Three more phases are planned proof of full vaccination will be required for people aged 12 and up starting Feb. 15, children aged five to 11 must show proof of one dose beginning Mar. 1, while those aged five and up must provide proof of full vaccination May 1 and onwards.

Wu also said the City will continue to support local businesses in implementing the policy, noting how signs have been distributed to restaurants and businesses outlining vaccination requirements to ease their burden of explaining the policy.

[Small businesses] continue to be anchors of our communities, Wu said at the conference. In other cities that have these policies, once it is fully implemented, it becomes part of the culture and the regular rhythm.

Ahmed Abdalla, manager of Jonquils Caf & Bakery on Newbury St., said in an interview that implementing the B Together initiative at the cafe was quite challenging.

He added that, sometimes, customers will try to evade showing their vaccination status by asking for their food to-go but then attempt to sit down at a table.

In general, most people cooperate, Abdalla said. It puts us into a difficult position because we dont want to make the customer feel like were harassing him or her.

Even those who are vaccinated have had trouble dining at restaurants. Osiris Ding, a senior in the Questrom School of Business, said he was denied entry into Copley Square Fogo de Cho Brazilian Steakhouse because they didnt accept his Chinese vaccination documents.

I had the school [proof of vaccination] that we had to upload at the start of the semester, he said, referring to the proof of vaccination documentation that BU requires. But they said thats not okay it has to be a CDC card and it has to be along with my ID.

To help people present their vaccine cards easily, the City launched the B Together app. Users can upload a picture of their vaccine cards and can even store pictures of their family members cards as well.

Ding said he might download the B Together app because it would be easier than having to bring his passport everywhere he goes.

Of course, its always better to be safer, he said. And it will make me feel a little bit secure if I can be sure that Im sharing a space where I know everyone is vaccinated.

Abdalla emphasized the need for cooperation while Boston still grapples with the pandemic.

Its not fun for us to keep asking [for proof], but its also not fun for customers, at least some customers, to be asked, he said. But, its a reality, and we all have to cooperate.

Speaking at the press conference, Wu stressed her support for businesses that will have to uphold the new vaccine mandate policy.

I will continue to stand with [small businesses], support them and make sure that the City is providing every resource we can to get our businesses back up and running and support our economy as we recover, Wu said.

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Boston introduces policy requiring proof of COVID-19 vaccination to enter certain indoor spaces The Daily Free Press - Daily Free Press