Category: Covid-19 Vaccine

Vaxxinity, Inc.

Investigator-sponsored studies show UB-612 induces high antibody activity against multiple variants, including Alpha, Beta, Delta, Gamma and Omicron, at levels similar to or higher than approved vaccines

UB-612 elicits >3 times higher titers of neutralizing antibodies against Omicron variant than reported by an approved mRNA vaccine

DALLAS, Feb. 11, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced results from studies demonstrating the ability of UB-612, its COVID-19 vaccine candidate, to elicit a broad immune response against multiple variants of concern, and specifically more than three-times higher titers of neutralizing antibodies against the Omicron variant of SARS-CoV-2 than an approved mRNA vaccine with boosters.

The ability of these sera to neutralize Omicron at these high levels is extraordinary and unprecedented considering that Omicron has more than 30 potential immune evading mutations and deletions across its spike protein, 15 of which are in the RBD region where our UB-612 vaccine is directed. Such data show that UB-612 could potentially be a unique vaccine candidate that is highly effective at mobilizing the immune system against a broad range of both current and future SARS-CoV-2 variants, said Farshad Guirakhoo, Ph.D., Chief Scientific Officer at Vaxxinity.

The studies were conducted by David Goldblatt, M.B. Ch.B., Ph.D., at University College London (UCL) and VisMederi, a Coalition for Epidemic Preparedness Innovations (CEPI)-centralized laboratory.

Sera from 92 participants from UB-612s Phase 2 study including 8 placebos (randomized and tested blinded) and up to 36 participants in the Phase 1 study, half of the latter boosted with a third dose of UB-612, were used in these studies to analyze binding of IgG and neutralization against multiple Variants of Concern and Variants of Interest, including Omicron.

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Key results from the studies include:

Three doses of UB-612 elicited neutralizing antibody titers of GMT VNT50 of 335 against the Omicron variant of SARS-CoV-2, over 3-fold higher than reported after three doses of an approved mRNA vaccine [1].

The receptor-binding domain (RBD)- and spike (S) protein-binding IgG antibodies after booster immunization with UB-612 produced high cross-reactivity against multiple SARS-CoV-2 variants, including Alpha, Beta, Delta, Gamma and Omicron, similar to or higher than those of approved vaccines and boosters [2].

The RBD-binding antibodies against the Wuhan strain reported for several authorized vaccines are predictive of UB-612 vaccine efficacy against COVID-19 at approximately 95% after three doses [2].

Vaxxinity plans to publish these data and present the findings at World Vaccine Congress in April 2022. UB-612 has been evaluated in Phase 1 and Phase 2 studies and is preparing to launch a global pivotal booster study later this year.

Mei Mei Hu, CEO of Vaxxinity, said, We are highly encouraged by these data as they show that UB-612 produces levels of neutralization comparable or exceeding current market leading vaccines while achieving a striking breadth of coverage against multiple variants of concern. Our hope is that we can provide a safe alternative vaccine option that can address not only todays COVID but also tomorrows and the next days mutations.

About the IgG Binding and Neutralization Studies

UCL performed multiple RBD- and Spike protein-binding assays on the UB-612 sera against multiple Variants of Concern/Variants of Interest and compared these to historical data generated with sera from subjects immunized with relevant approved comparator mRNA and Adenovirus COVID-19 vaccines in the same assays.

VisMederi assessed neutralization of UB-612 in live VNT assays against a Wuhan-like prototype strain (Italy INM1 strain), Omicron and Delta. VisMederi is part of the CEPI laboratory network and has developed validated live VNT assays referenced in regulatory submissions and scientific publications.

About UB-612

UB-612 is the first multitope protein/peptide-based vaccine candidate for SARS-CoV-2. The vaccine candidate is designed to activate both B and T-cell arms of the immune system. Phase 1 and Phase 2 trials of UB-612 have shown UB-612 to be well tolerated with no significant safety findings to date, while observing UB-612 generated antibodies that can bind to the S1-RBD protein and neutralize SARS-CoV-2, in addition to driving a T-lymphocyte response.

About Vaxxinity

Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The companys proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimers, Parkinsons, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.

For more information about Vaxxinity, Inc., visit http://www.vaxxinity.com and follow us on social media @vaxxinity.

Forward-looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe," "may," continue, advancing, and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Vaxxinitys management about the development of a new class of immunotherapeutic vaccines and the innovation and efficacy of Vaxxinitys product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on December 23, 2021. The forward-looking statements are made as of this date and Vaxxinity does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor ContactClaudia Styslingervaxxinity@argotpartners.com

Press ContactPhilip Cowdellmedia@vaxxinity.com

[1] For further details on the method, please see Muik, A. et al, Science. 2022. Data from UB-612 were generated at the same laboratory as part of the CEPI centralized laboratory network. There may be minor differences that could have influenced the outcome of the study, including but not limited to sample size, virus dose amount used, and the fact that samples were not tested head-to-head.

[2] Comparison to historical data generated from comparator vaccines. Goldblatt et al, Vaccine 2022.

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Vaxxinity's COVID-19 Vaccine Candidate UB-612 Produces High Levels of Neutralizing Antibodies Against Omicron and Other Variants of Concern - Yahoo...

2022-02-10

It has now been 60 weeks since the first shipments of the COVID-19 vaccine were sent out to states, kicking off the largest vaccination campaign in human history. As of February 8, the U.S. has sent 671,790,965 doses of the vaccine across the country equivalent to 204.7% of the U.S. population.

While the initial distribution of the vaccine took longer than federal projections had indicated, in recent months the U.S. has made great leaps in the worldwide race to administer vaccinations and some states are faring far better than others. Under the current system, led by the White House COVID-19 Response Team, the Centers for Disease Control and Prevention sends states limited shipments of the vaccine as well as funding and tasks them with distributing the vaccine in accordance with relatively loose federal guidelines. The distribution of the vaccine is based on the size of the adult population in every state, which according to some experts can create inequities in states where the spread of COVID-19 is worse and a larger share of the population is at risk.

Wisconsin has received a total of 10,815,985 doses of the COVID-19 vaccine as of February 8. Adjusted for population, Wisconsin has received 185,764.0 vaccines per 100,000 residents less than the national average of 204,664.9 vaccines per 100,000 Americans and the 16th fewest of any state.

While Wisconsin has so far received fewer vaccines per capita than the nation as a whole, the state has a greater need for vaccines than the rest of the country. As of February 8, there were 26,370.5 confirmed cases of COVID-19 per 100,000 residents in Wisconsin greater than the national rate of 23,120.3 cases per 100,000 Americans and the ninth highest of all 50 states.

While the federal government distributes vaccines to states, it is up to state governments to administer the vaccine creating variations in both the percentage of vaccines that have been administered and the percentage of the population that has been vaccinated. In Wisconsin, 90.0% of allocated vaccines have been administered to residents, greater than the national average of 81.0% and the largest share of all states.

The administered vaccines amount to 167.2% of the state population, in line with the 165.8% national figure and the 21st largest share of all states.

While a majority of Americans remain unvaccinated due to a lack of supply, there are some who have no plans to receive a vaccine at all. According to a survey from the U.S. Census Bureau, 64.4% of U.S. adults 18 and over who have not yet received the vaccine will either probably not or definitely not get a COVID-19 vaccine in the future. In Wisconsin, 74.8% of adults who have not yet received the vaccine report that they will probably not or definitely not get a vaccine in the future, the 10th largest share of any state. The most common reason cited for not wanting a vaccine was being concerned about possible side effects. Other commonly cited reasons include not trusting COVID-19 vaccines, believing they don't need a vaccine, and not trusting the government.

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This Is How Many COVID-19 Vaccines Wisconsin Has Received So Far - Patch.com

Mitigation of the observed risks of myocarditis/pericarditis and associated uncertainties will be accomplished through labeling (including warning statements about the risks of vaccine-associated myocarditis/pericarditis) and through continued safety surveillance and postmarketing studies to be conducted by the Applicant, US government agencies (including FDA and CDC), and other healthcare stakeholders. [Emphasis added]

Myocarditis and pericarditishave historically been rare. They are defined as inflammation of the heart muscle or layers of the pericardial sac, respectively.Both conditions cause recognizable ECG changes and have ambiguous symptoms that include shortness of breath and chest pain. Myocarditis and pericarditiscan easily be diagnosed clinically with echocardiograms and can be treated by inexpensive pharmacology and bedrest, but for that to happen, people need to know to seek medical diagnosis and care.

The Vaccine Adverse Event Reporting System (VAERS), jointly run by FDA and CDC, lists a long and impersonal number of cardiovascular-related events in young, healthy people, but without reading the underlying narratives submitted with the reports, its hard to establish the precise causal links regarding these adverse events. Studies acknowledged by FDA officials show that the FDA's various safety databases only collect somewhere between 1 to 13% of all adverse events that actually occur. During official FDA presentations, multiple FDA drug safety epidemiologists have stated that it only takes a single, well-documented adverse event to justify a safety signal investigation and, in turn, warn the American public of the risk.

Historically, the FDA has sought safety warnings on labels, up to and including a black boxed warning and a prescribing restriction known as a Risk Evaluation and Mitigation Strategy (REMS). For instance, in 2008, after less than 200 spontaneous F/AERS reports of tendon rupture following administration of the class of antibiotics known as fluoroquinolones, FDA added a black boxed warning and the REMS prescribing restrictions. Yet serious, debilitating, and deadly safety VAERS reports following COVID vaccines/boosters are not being held to the same regulatory standards. If only 1-13% of adverse events are reported, extrapolating those numbers means the actual number of adverse health events could easily be underreported.

In addition to VAERS, the CDCs Vaccine Safety Datalink shows an excess risk of myocarditis and pericarditis in recipients following the Pfizer and Moderna vaccines.The cardiovascular risk after any mRNA vaccine is high, but with Moderna, its approximately four times higher than Pfizers. For context, The CDC Vaccine Safety Datalink placed the excess cases of myocarditis and pericarditis at 13.1 cases/million doses administered to those age 18-39. (Roughly 300 excess cases overall).

Other public health agencies with much tinier budgets and staff compared to our FDAs, took action on this in October. Denmark, Finland, Norway, and Sweden suspended the use of the Moderna vaccine for young people, but its still full speed ahead here in the USA.

Since then, more data has been released affirming the same: A recent CDC and FDA study published in JAMA shows the risk of myocarditis following any kind of mRNA COVID vaccination is greater than the background risk in the population, with the largest proportions of cases of myocarditis occurring among white males

A comprehensive study from Britain from December 2021 examined data from over 42 million people who have taken a COVID-19 shot found a noteworthy increase in myocarditis with mRNA vaccines which persisted and increased with every dose and booster.

These findings have important implications for public health and vaccination policy.

Indeed they do -- especially in light of the highly questionable manner in which the FDA approved vaccines in kids from 5 to 13 years old, and the currently pending FDA applications to approve vaccination in babies from 6 months and up.

Knowing that the Pfizer and Moderna vaccines can cause myocarditis, vaccine safety scientists need to look at other cardiovascular-related adverse effects. The FDA, CDC, and manufacturers have access to VAERS and other high-quality denominator-based vaccine safety systems, including the Biologics Effectiveness and Safety Initiative (BEST), Defense Medical Epidemiology Database (DMED), and the Vaccine Safety Datalink (VSD), respectively.

Have manufacturers and our health agencies used these tools and others to thoroughly investigate the cardiovascular health risks of the vaccine?

Therein is the problem:providers and patients are not being adequately warned to monitor for cardiovascular symptoms despite the increased incidence. Pfizer and Moderna should use their considerable resources to research, publish and inform young people about the risk of myocarditis and pericarditis after taking their vaccines. Additionally, pharmacists should educate patients about adverse reactions such as myocarditis and pericarditis.

Going forward, Americans need safety warnings and transparency.from someone

On February 4th, 2022, aCDC advisory committeeproposed extending the gap between COVID-19 shots to mitigate the cardiovascular damage of the vaccine.This details the fact that the federal government is aware of the serious risk, but rather than actually addressing the risk head-on and loudly communicating the risk to the public; they are taking the "half-measure" of just changing the interval and hoping to mitigate risk without evidence that it will have any effect on the outcome.

Since manufacturers and the FDA fail to address this and other untoward effects of mRNA utility and mandates, additional drug safety experts need to publicly address mRNA COVID vaccine safety.

Vaccines are one of the most important inventions in human history, saving millions of lives. That does not mean that every person should get every vaccine, and like every drug out there, it is critically important to detect and report safety problems quickly.

The failure to adequately monitor and warn for COVID vaccine adverse events has not only served to harden COVID vaccine hesitancy but has shredded the credibility of Americas public health authorities. The failure to encourage open conversation about known adverse reactions erodes trust. We are long past the day when hiding information from the public is considered suitable for public health. It never is.

It is not only unethical and disrespectful to patients; its dangerous.

[1] Clinical Review Memorandum of Pfizer vaccine

Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health care policy fellow at theEthics and Public Policy Centerin Washington, DC. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he served at Yales Bioethicist Center and was anFDA Medical Officerwho was later appointed by the White House to serve on the FDAs Senior Executive LeadershipTeam assenior advisor to the FDA Commissionerfordrug safety, FDA science policy, and FDA regulatory affairs. He is a regular columnist at Forbes, where he writes on drug safety, healthcare, and FDA policy.

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Manufacturers, the FDA, and others not adequately addressing Cardiovascular COVID-19 Vaccine Risks - American Council on Science and Health

New Study Highlights Social Medias Key Role in COVID-19 Vaccine Uptake for Migrants

Berlin -- Governments could close COVID-19 vaccination gaps by breaking down language barriers and giving migrants easier access to information particularly through social media, according to a study published today by the International Organization for Migration (IOM) and the University of Potsdam.

Studies from several countries in the US and Europe, including Germany, suggest that vaccination rates are lower among migrant communities compared to the general population. Gaps may vary by country and group but a recent study by the Robert Koch Institute in Germany revealed that the vaccination rate among migrants is 8 per cent lower compared to the native-born population. The study argues that such vaccination gaps may be linked to language barriers, socioeconomic status, and misinformation among migrant communities.

IOM's Global Migration Data Analysis Centre (GMDAC) and the University of Potsdam tested the effect of language and trust barriers in Germany via a social media campaign in their study, "Promoting COVID-19 vaccination uptake among migrant communities on social media -- Evidence from Germany''.

"More evidence on the interlinkage between migration and health is urgently needed," said GMDAC Director Frank Laczko. "Many countries around the world have large migrant populations, yet many of them do not consider the needs of migrants sufficiently in their vaccination programmes."

Expensive national campaigns to boost vaccine uptake using print, TV, and radio often neglect social media. The results of the study show how specific groups can be reached more effectively and at low cost.

"Social media is where misinformation spreads and it is important that official public health messages are visible online and reach out to communities that are generally not exposed to mainstream media, print or TV campaigns," said Esther Haarmann, GMDAC Digital Communications Officer and co-author of the study.

Local authorities often lack the resources to make translations available. The results highlight how many migrants are left behind by not translating outreach materials. Social media advertisements in the language of origin of migrants dramatically increased the interest in COVID-19 vaccine appointments, especially for newly arrived migrants (by 133 per cent for Arabic speakers, 76 per cent for Russian speakers and 15 per cent for Turkish speakers).

Extrapolating the translation effect to all government outreach targeting migrants could have the potential to increase vaccination rates among migrants by 14 percentage points on average. This improvement would likely close vaccination gaps between migrant groups and the general population in Germany -- and in other countries.

Results also revealed that ad content showing an official government representative was more effective in increasing interest in COVID-19 vaccine appointments than other messengers such as religious leaders, families or doctors, especially among recent immigrant groups in Germany (Arabic speakers in this study).

"The results highlight the potential of local government authorities to reach migrants -- a population often believed to have higher levels of mistrust in institutions," says Jasper Tjaden, Professor at the University of Potsdam, and lead author of the study.

Dr Nicolai Savaskan, the director of the health department in the district of Berlin-Neuklln, said local health departments benefit from evidence-based guidance on how best to reach diverse communities.

"In-person outreach is the gold standard, but we cannot reach everyone this way," Dr Savaskan said. "New evidence shows that online campaigns can fill the gap and are increasingly an important instrument in official health communication."

While the study focused on Germany, the methodology is scalable to other countries to improve outreach and support equitable access to health services, including for refugees, asylum seekers, migrants in irregular situations, and hard-to-reach populations.

Download the study here.

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Promoting COVID-19 vaccination uptake among migrant communities on social media: Evidence from Germany (February 2022) - Germany - ReliefWeb

And protesters' demands have escalated, not just insisting that vaccine mandates be lifted for everyone, but calling for an opening to all businesses including restaurants and gyms, dropping capacity limits at large events and eliminating mask mandates -- especially in schools.

Here are some political and legal scenarios that could play out:

Give peace a chance -- convince protesters to leave voluntarily

This is the preferred choice for law enforcement officials who say they recognize Canadians' right to protest. Police in Windsor, Ottawa, and Alberta have stated that they have tried to keep lines of communication open to protest organizers and individual activists, trying to convince them to leave voluntarily.

This has had limited success, with protesters bolstered by both messages of support online and material support on the ground with money and supplies. On Thursday, Ottawa police reported that nearly two dozen trucks had been voluntarily removed from two different protest sites. But hundreds remain, still blocking city streets.

And negotiations at border protests have had very limited success, especially in Alberta, where communication efforts seem to have hardened the position of protesters.

CNN has spoken to some truckers who say they might consider leaving if Prime Minister Justin Trudeau would only speak to them directly about their concerns.

"These gentlemen, these guys over in that building and they can just come out and show some respect and you know, at least talk to us," said a driver who identified himself as Doran, parked in front of Canada's parliament.

Governments give in to protesters' demands

This is perhaps the least likely of all scenarios. Police and political leaders say it would set a dangerous precedent to give in to "angry crowds," in the words of the prime minister. Several provinces, including Saskatchewan, Alberta and Ontario, have announced in recent days that they will drop some restrictions.

Saskatchewan is making changes the most dramatically and quickly, by eliminating its vaccine passport system, dropping mask mandates and reporting Covid-19 cases weekly instead of daily. Alberta is also dropping its mask mandate for children and getting rid of its vaccine passport program.

Ontario recently opened restaurant dining rooms and has restored most sporting activities for children and adults.

These decisions, however, are unconnected to the protests given that those governments have consistently said that their goal is to lift Covid-19 restrictions as soon as cases and hospitalizations drop.

Protesters in Ottawa have also indicated to CNN that they will not be affected by a piecemeal approach to lifting restrictions. They are demanding a nationwide rollback of all Covid-19 health measures.

Authorities remove trucks and cars from protest sites

Ottawa officials have been pursuing vehicle-removal options for days, but they have towed very few cars, let alone trucks. They say their efforts are frustrated by tow truck drivers and companies who fear damage to their businesses or worse, a violent confrontation.

Ottawa police say they are actively investigating reports that tow truck operators have been threatened and intimidated. Police say they do have some towing capacity but not enough to move a substantial amount of trucks from protest sites without help from private tow truck companies. Ottawa police say they have issued more than 1,700 tickets, and fines for city infractions have in some cases been doubled or tripled.

City and provincial officials, responsible for insurance and licensing, also say they are looking to step up enforcement with infractions for parking, insurance and license violations, but this too could take weeks to have any effect.

Police forcibly remove protesters

Law enforcement and politicians have been trying to avoid this scenario, fearing both protesters and officers could get hurt. Not only does this risk escalating tensions further and potentially inciting more angry protesters to hit the streets in other parts of the country, but it would require many more officers than are currently available.

Ottawa's mayor, Jim Watson, sent a letter to the prime minister and premier of Ontario asking for reinforcements of 1,800 officers, including administration staff.

In a letter provided to the media, Watson writes, "We must do everything in our power to take back the streets of Ottawa."

The Trudeau government says it continues to dispatch more officers with the Royal Canadian Mounted Police to several protest sites, but Ottawa's request for 1,800 extra officers are unlikely to materialize soon, if ever.

Ottawa police say they have made 25 arrests to date. Arresting and forcibly removing protesters, however, may be an option that police consider.

"There will be accountability for any unlawful criminal activities that occur in this city in relation to this demonstration," said Sloly, Ottawa's police chief, during a Thursday press conference.

"I know many are just saying have the police go in there and move everyone out and restore law and order. And that's sensibly what we all want to see happen," Windsor Mayor Drew Dilkens told CNN in an interview Wednesday. "The problem is you have a number of folks who are looking for confrontation. You have people who have expressed themselves in the media saying that they believe this is a cause that they are willing to die for."

Use the military to restore order

This is not only the least preferred option but highly unlikely.

Last week, after Sloly suggested it might take the military to resolve protests, he was met with stiff resistance from the federal government. Through a spokesman, Defense Minister Anita Anand told CNN that Canada's armed forces are not a police force and that they "are not involved in law enforcement in this situation."

Trudeau elaborated further last week, saying, "One has to be very, very cautious before deploying military forces in situations engaging Canadians. It is not something that anyone should enter in lightly."

Under Canada's Defense Act, a province may request that, "where a riot or disturbance occurs or is considered as likely to occur," the attorney general of the province can request the services of the military "to be called out on service in aid of the civil power."

However, this is for the province to request and the federal government determines whether to grant the request.

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They are protesting Covid restrictions and support is growing. This is what could happen in the Canada protests next - CNN

Truckers and their supporters continue to protest COVID-19 vaccine mandates in Ottawa  Denver Gazette

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Truckers and their supporters continue to protest COVID-19 vaccine mandates in Ottawa - Denver Gazette

A vial labelled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/File Photo

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Dec 16 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Thursday they have filed for full approval of their COVID-19 vaccine with the U.S. Food and Drug Administration to include adolescents aged 12 to 15.

The vaccine received full approval for ages 16 and above in the United States in August. The shot also has an emergency use authorization for 5 to 15 year olds.

Pfizer is seeking for an approval based on long-term data from a late-stage study conducted among adolescents. The company said in November the two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose.

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The company is seeking clearance for a 30 micrograms dose of the vaccine for those aged 12 and above. Pfizer/BioNTech's vaccine is the only COVID-19 vaccine authorized for the given age group in the U.S.

Pfizer said it expects to file for approval with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.

The FDA gave the two-dose vaccine emergency-use authorization for adolescents in May.

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Reporting by Dania Nadeem in Bengaluru; Editing by Aditya Soni and Shounak Dasgupta

Our Standards: The Thomson Reuters Trust Principles.

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Pfizer files for full FDA approval of COVID-19 vaccine in ...

Johnson & Johnson temporarily halted production of its COVID-19 vaccine in the Netherlands, the only manufacturing hub making usable doses for the pharmaceutical company, according to a New York Times report on Tuesday.

The company stopped production of the vaccine at its facility in the Dutch city of Leiden at the end of 2021 and has instead turned its attention to making another vaccine for an unrelated virus, the Times reported. The pause is temporary and is expected to last just a month but it could reduce Johnson& Johnson's vaccine supply by a few hundred million doses.

While the Johnson & Johnson vaccine from Janssen Pharmaceuticals has been linked to rare blood clots and is considered less effective than Pfizer's and Moderna's shots by the Centers for Disease Control and Prevention,it is extremely important in Africa and low-income countries, which rely on the simpler one-dose shot.

The vaccine also avoids the requirement of storage in ultra-cold temperatures, which makes shipment of Moderna and Pfizer doses more difficult.

In October, Johnson & Johnson said it was committing about 50 million vaccines to 40 countries through COVAX, the vaccine-sharing initiative from the World Health Organization and the United Nations.

ButAyoade Alakija, a co-head of the African Unions vaccine-delivery program, told the Times that switching up production could endanger the vaccination effort.

This is not the time to be switching production lines of anything, when the lives of people across the developing world hang in the balance, she said.

A spokesperson for the company told The Hill that millions of doses were in inventory and they were still planning to "fulfill our contractual obligations" related to COVAX and the African Union.

"We strive to improve human health and have worked tirelessly to forge partnerships and build a global manufacturing network across four continents to produce our COVID-19 vaccine. In addition, we expanded the capacity of our facility in Leiden in 2021, and the site continues to play a role in our vaccine manufacturing in 2022," the spokesperson said.

"Our manufacturing sites produce multiple products as we have an obligation to supply life changing medicines to patients around the world and bring forward our innovative pipeline of new medicines and vaccines. We manage our production planning accordingly and are currently supplying from our extensive global network based on the demand for our vaccine and the needs of our patients and customers," the spokesperson added.

Millions of Americans have received Johnson & Johnson's vaccine, and the companyearned $2.39 billion in vaccine sales in 2021.Johnson& Johnson is estimating even higher sales in 2022, ranging between $3 billion and $3.5 billion.

According to the report from the Times, Johnson & Johnson is planning to revive three other manufacturing plants to produce its COVID-19 vaccine, including a facility in Baltimore that was shut down in April following a failure to meet federal guidelines.

Updated at 3:59 p.m.

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COVID-19 vaccine production quietly suspended at Johnson & Johnson: report | TheHill - The Hill

COVID-19 vaccine perceptions and uptake: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey  The Lancet

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COVID-19 vaccine perceptions and uptake: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey - The Lancet

When the COVID-19 vaccines became available, many health care workers, despite seeing the devastating effects of the virus firsthand, said they did not intend to get vaccinated. But a new Northwestern Medicine study shows how quickly many of them at a large urban health care system changed their minds, resulting in a vaccination rate of 95% by spring 2021.

The study found:

This study found health care workers attitudes about COVID-19 vaccination could change in a very short period of time, said lead study author Charlesnika Evans, professor of preventive medicine in epidemiology at Northwestern University Feinberg School of Medicine. It shows there is opportunity to change peoples decisions about not getting vaccinated.

The study was recently published in the journal Infection Control & Hospital Epidemiology.

The first survey for this analysis was administered to 4,180 Northwestern Medicine health care workers who enrolled in the study in December 2020 through February 2021. The second survey was in June 2021. The survey asked about health care workers COVID-19 exposures and experiences and COVID-19 vaccination status. The participants also underwent blood testing to measure their antibodies at enrollment in spring 2020 and six months after enrollment.

Multiple factors likely contributed to health care workers changing their minds, Evans said. They included clear messaging about the safety of the vaccines, convenient access to vaccinations at the hospital, awareness that workplace mandates were coming in the future, as was the Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration.

We saw a significant change in the number of people who said they would get the vaccine after the EUA was issued. People may have felt, OK, this might be safe for me to take.

Gender, race, and occupation played a role in vaccination acceptance, the study showed. Nurses (versus physicians), non-Hispanic Black (versus Asian) health care workers, and women versus men were less likely to report an intention to get vaccinated.

Individuals who showed negative antibody results were more likely to get vaccinated. People older than 65 years of age were more likely to get vaccinated. Women had a lower intention to get vaccinated than men, especially those who were in their reproductive years. Nurses also had lower intentions to get the vaccine, despite the reports that nurses have the highest rates of COVID-19 within health care workers.

One way to address mistrust is including people who have not traditionally been in research studies, making more of an effort to include them in vaccine or research studies in general, Evans said.

The fact that they didnt actively recruit pregnant women into the vaccine studies makes sense early on, but to prove and be sure its safe and effective, inclusion of these groups in trials is important, Evans said. However, so far CDC data show that pregnant women have not experienced more adverse events than the general population.

Furthermore, while a good portion of Black participants in the study eventually got vaccinated, mistrust in the health care system is a concern, Evans said.

Thats a larger issue to be addressed within society in general that goes way beyond this study, Evans said. We must continue thinking about how to improve our messaging and addressing the issues around mistrust toward the health care system. This is imperative for COVID-19 and other conditions.

Reference: Coronavirus disease 2019 (COVID-19) vaccine intentions and uptake in a tertiary-care healthcare system: A longitudinal study by Charlesnika T. Evans, Benjamin J. DeYoung, Elizabeth L. Gray, Amisha Wallia, Joyce Ho, Mercedes Carnethon, Teresa R. Zembower, Lisa R. Hirschhorn and John T. Wilkins, 27 December 2021, Infection Control and Hospital Epidemiology.DOI: 10.1017/ice.2021.523

Northwestern authors are principal investigator John Wilkins and co-authors Benjamin DeYoung, Elizabeth Gray, Amisha Wallia, Joyce Ho, Mercedes Carnethon, Teresa Zembower and Lisa Hirschhorn.

The research was funded by Northwestern University Clinical and Translational Sciences Institute (UL1TR001422) and the Northwestern Memorial Foundation.

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Health Care Workers Change Their Minds on COVID-19 Vaccines - SciTechDaily