Category: Covid-19 Vaccine

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Our COVID-19 Response Efforts | Johnson & Johnson

November 23, 2021

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ohnson & Johnson has been actively engaged in fighting pandemics for over a century. We have done it before, and we will do it again.

With our global reach comes a responsibility and unique ability to leverage our deep scientific expertise and extensive partnerships to take on this challenge. Our more than 130,000 employees around the world mobilized with urgency to address the critical needs of families, communities and healthcare providers around the world.

Our commitment to families around the world doesnt change in a time of crisis: well never stop taking care of you.

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Our COVID-19 Response Efforts | Johnson & Johnson

EU says decision on J&J COVID-19 vaccine booster dose ‘within weeks’ – Reuters

November 23, 2021

A vial of the Johnson & Johnson's coronavirus disease (COVID-19) vaccine is seen at Northwell Health's South Shore University Hospital in Bay Shore, New York, U.S., March 3, 2021. REUTERS/Shannon Stapleton

Nov 22 (Reuters) - The European Union's drug regulator said on Monday it was evaluating data on booster doses of the COVID-19 vaccine by Johnson & Johnson (JNJ.N) following an application, and a decision could come "within weeks" under a speedy review.

The approval sought is for use of a booster dose of the single-shot vaccine, COVID-19 Vaccine Janssen, to be given at least two months after the first dose to people aged 18 years and older, the European Medicines Agency (EMA) said.

Faced with surging cases of COVID-19, the European Union has sped up its process for approving boosters and viable treatment options beyond vaccines. Booster campaigns were initially focused on the elderly and those with weakened immune systems.

The European Union has so far given mRNA vaccines from the Pfizer-BioNTech (PFE.N), (22UAy.DE) alliance, and Moderna (MRNA.O) the go-ahead as a third booster dose at least six months after a standard two-shot course. It is also considering AstraZeneca's (AZN.L) booster doses. read more

U.S. regulators last week expanded eligibility for booster shots of the Pfizer-BioNTech and Moderna's COVID-19 vaccines to all fully-vaccinated adults, having previously approved boosters for all recipients of the J&J vaccine. read more

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Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli

Our Standards: The Thomson Reuters Trust Principles.

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EU says decision on J&J COVID-19 vaccine booster dose 'within weeks' - Reuters

COVID-19 vaccination status and time until return to work among healthcare workers – News-Medical.net

November 23, 2021

Healthcare services worldwide have been suffering under increased burdens since the coronavirus disease 2019 (COVID-19) pandemic first arose in Wuhan, China. While many countries worked to prevent transmission from rising, there was no vaccine available and few treatments.

Healthcare workers (sometimes called frontline workers) were the most at risk, and when a vaccine was developed, most governments prioritized healthcare workers. Researchers from the University Of Southern California have been examining the effect of vaccination on the time it takes healthcare workers to return to work following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Study: Healthcare workers benefit from second dose of COVID-19 mRNA vaccine: Effects of partial and full vaccination on sick leave duration and symptoms. Image Credit: Boyloso/Shutterstock

A preprint version of the study is available on the medRxiv* server while the article undergoes peer review.

The researchers examined data from clinical and non-clinical healthcare workers at two large hospitals and multiple outpatient clinics, and other facilities. All of these workers were vaccinated with the Pfizer-BioNTech vaccine between December 2020 and July 2021. These healthcare workers were tested weekly for COVID-19 and further tested whenever they showed symptoms or had been exposed to an infected individual.

Those who tested positive for the disease were interviewed immediately and then three to four times weekly by phone or tests to assess their fitness to return to work, following a minimum quarantine of 10 days with at least 24 hours of minimal to no symptoms. The questionnaire included age, sex, ethnicity, vaccination status, and presenting symptoms. The researchers also collected data on the number of days between the initial symptom onset/positive test date and the first day back at work following recovery.

Healthcare workers who took over 100 days to return to work were excluded, as these were generally representative of special circumstances unrelated to their illness. The researchers used bivariable analysis to compare fully vaccinated, partially vaccinated, and unvaccinated individuals with their return-to-work days and demographics. Multiple regression analyses were used to determine the association or lack thereof between vaccination status and return to work days, controlling for demographic variables. The chi-squared analysis compared the symptoms experienced by each group.

In total, the scientists found that 1,030 healthcare workers tested positive over the analysis, 78 of which were excluded due to various factors. This resulted in 811 unvaccinated healthcare workers, 116 partially vaccinated and 25 fully vaccinated. The mean return-to-work time was 18.49 days. The groups did not differ significantly by age or sex, but fully vaccinated individuals were less likely to be vaccinated.

After controlling for demographic factors, fully vaccinated individuals showed the shortest return to work time at 10.9 days, only slightly longer than the mandated minimum. Partially vaccinated healthcare workers were also more likely to return quicker than unvaccinated workers, at 15.5 days compared to 18.0 days. Demographic factors did not affect return-to-work days. Vaccinated individuals were most likely to be asymptomatic and nasal, and coughs became more likely the less vaccinated the individual.

This study was performed before the Delta variant became the most common new infection in the U.S. The Delta variant is significantly more likely to cause vaccine breakthrough infections, and it is unclear how drastically this could have changed the results of the study.

However, the results demonstrate that vaccination significantly affects the amount of time required to return to work following COVID-19 infection. This benefits healthcare workers' health, financial security, and fitness and lowers the overall burden on healthcare facilities. Longer return to work times requires organizations to hire temporary replacements which can often cost more than more experienced workers, as the time taken to train them can hinder efficiency. Hospitals with extensive sickness among their staff have significantly reduced capacity.

The authors highlight that these benefits are significant and urge the consideration of the implications of this research on public health, health institutions, and the burden placed on the healthcare system as a whole. As cases begin to rise again, some European countries are considering or have already entered into another lockdown, and the Delta variant is considerably more virulent than wild-type SARS-CoV-2. Prioritizing vaccinating healthcare workers could save a significant amount of lives.

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information

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MCPS softens COVID-19 vaccination mandate to allow for weekly testing instead – BethesdaMagazine.com

November 23, 2021

Montgomery County Public Schools has backed away from firing employees who dont get the COVID-19 vaccine because it cant afford to lose anyone, a spokesman said.

The district in recent weeks has acknowledged a dire staffing shortage during the pandemic affecting teachers, substitutes and support staff

But it also announced near the beginning of the academic year that all of its nearly 25,000 employees would be required to be vaccinated against COVID-19 or potentially be terminated. It was not allowing those who were unvaccinated to instead be tested weekly, unless they were granted a medical or religious exemption.

But in a recent message sent to employees, MCPS wrote that employees who reported that they are not vaccinated about 700 would be able to instead submit proof of a negative COVID-19 test each week. If the weekly test results are not submitted, employees will face disciplinary action up to and including termination, the letter said.

As of Friday evening, 578 employees had not reported their vaccination status. There was no update as of Monday.

Those employees received a formal letter of reprimand and will not be paid for work on Nov. 24, which is a holiday. They could face further discipline if they continue to fail to attest to their vaccination status after Nov. 24, according to the message.

MCPS spokesman Chris Cram said in an interview on Monday that the change was made, in part, because we cant afford to start letting people go.

We need every staff member we have, he said, but we need every staff member to understand how important this is to safety.

He said that the COVID-19 vaccination approval for children ages 5 to 11 which was not available when the mandate was first passed also creates less of a need to mandate the vaccination for employees.

According to county health officials, about 28,452 children in the age group had received the first dose of the two-dose vaccine regimen as of Sunday. In total, 88.6% of all Montgomery County residents are at least partially vaccinated against COVID-19, according to the Centers for Disease Control and Prevention. About 78.6% are fully vaccinated.

MCPS employees who need to test each week can do so at some school sites, or use up to two hours of unusual and imperative leave to complete the required testing.

It is important and expected that each employee that is required to test do so at a time and in a manner that is least impactful to the operation of their school or office, the districts message said. School staff must schedule their required testing at times that will not require substitute coverage.

Caitlynn Peetz can be reached at caitlynn.peetz@bethesdamagazine.com

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MCPS softens COVID-19 vaccination mandate to allow for weekly testing instead - BethesdaMagazine.com

Plenty of COVID-19 vaccine appointments available in Triangle ahead of the holiday – CBS17.com

November 23, 2021

RALEIGH, N.C. (WNCN) COVID-19 vaccine clinics could get busier as people look to get more protection in time for the holidays.

Bibiche Musasa is fully vaccinated but went to a Wake County vaccination location to sign up her sister for a vaccine.

I want to be safe, everyone to be safe, too. So, holidays are coming. Were going to share together so thats why its very important to take the shot. Very important, Musasa said.

CBS 17 checked vaccine clinics around the Triangle and found no shortage of appointment openings for either boosters or the first rounds of shots.

Dr. Weber with the UNC School of Medicine said people should be able to get in fairly quickly.

I think there will be a bit of a rush but I dont think itll last very long because I think theres enough vaccine to to go around, he said.

Getting a booster shot now wont rev up your immune system in time for Thanksgiving. It takes two weeks to take full effect.

If you get a booster shot as soon as Tuesday, antibodies would kick in by Dec. 6 putting you at peak protection for Christmas week.

Its not like this an automatic line youre not protected at day 13 and your protected at day 14 really. It is the further out from the booster of the somewhat better protection you get, Weber.

Anyone planning to leave their daily bubble for the holidays should be the first to rush out for a booster shot.

If they want to go to religious ceremonies, fun things to do, like New Years parties, or going out to restaurants and bars, then they ought to get their booster shot as soon as feasible, Weber.

Weber said booster shot or not, some protection is better than nothing at all.

If they love their family, they have to come. They have to come take a shot, said Musasa.

Starting Tuesday, Wake County Public Health will begin to offer boosters to everyone 18 and over. Other pharmacies and counties are already offering them.

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Plenty of COVID-19 vaccine appointments available in Triangle ahead of the holiday - CBS17.com

Many men dont take good care of themselves. COVID-19 vaccine rates are the latest in a problem as old as medicine. – The Philadelphia Inquirer

November 23, 2021

They are less likely to see the doctor. They eat fewer fruits and vegetables. Theyre more likely to smoke, die in alcohol-related crashes, and engage in other activities that can lead to traumatic brain injury. By nearly every measure known, men fall short of women when it comes to taking care of themselves.

And for months now, to the surprise of few in the medical profession, men consistently have lagged behind women in getting a COVID-19 vaccine. As of mid-November, 57% of men and boys in the U.S. were fully vaccinated, compared with 61% of women and girls.

The male reluctance to seek medical care is so well-documented, and so exhaustively talked about, that its become a punch line. And that can make solutions difficult, said James Leone, a health professor at Bridgewater State University in Massachusetts.

The reason men often live sicker and die sooner is we allow it, he said. As a society, we dont go beyond the surface levels, and just say, Oh, thats a shame. Whats wrong with guys?

But theres nothing funny about men living sicker and dying sooner than women especially when the decisions they make about their health can have medical and economic ramifications for their families, as has become apparent during the COVID-19 pandemic. More than 40,000 children have lost a parent to COVID-19, and many more have experienced food or housing insecurity after their parents lost jobs or were unable to work.

So whats going on with men and their health?

Doctors, psychologists, evolutionary theorists seem to agree that it all comes down to men having a higher tolerance for risk. But untangling the cause is complicated. Some researchers think the trait is a genetic holdover from ancient times, when men who engaged in aggressive, risk-taking behavior could out-compete their peers for mates and food. Others say mens higher risk tolerance is primarily a learned quality, fostered by social and cultural norms of masculinity.

READ MORE: In most ways, women age better than men and live longer. Scientists are trying to figure out why.

Although women can be risk-takers, too, on average, the difference is undeniable, said Daniel J. Kruger, an evolutionary psychologist at the University of Michigans Institute for Social Research. Whatever combination of nature and nurture is at work, these characteristics have become deeply etched into our society over centuries. Public health campaigns are exploring new ways to get their messages to resonate with men, but changing such ingrained behavior will take considerable and concerted effort.

This goes way back in our evolutionary history, he said. It doesnt determine our behavior, but it certainly influences it.

During the pandemic, the male-female divide was put on stark display.

Since 2018, researchers at Indiana University in Bloomington have been conducting a long-term study of 250 opposite-sex couples, surveying them about a series of what Jessica Calarco, an associate sociology professor at Indiana University, called fraught topics for new parents among them breastfeeding, childhood vaccines, co-sleeping, and at what point either partner goes back to work.

When COVID-19 hit, Calarco and her colleagues added pandemic-themed topics to the mix.

Among the key findings: Two-thirds of couples disagreed about what level of risk was acceptable for their family. In most cases when the man and woman disagreed, it was the woman who was more risk-averse and adhered more diligently to safety guidelines, such as wearing masks and maintaining social distance.

Because women were the ones taking the more risk-averse positions, they were also the ones pressured to be the peacekeepers when this did turn into conflict, Calarco said. Women felt responsibility for fixing the conflict, or preventing it from escalating.

They did that by taking on the burden of ensuring the familys safety themselves and in many cases taking extra precautions to protect children or elderly relatives from their spouses riskier behavior, she said.

This isnt a function of biological differences but the pressures put on women to be caregivers, to think about themselves and everyone else around them, Calarco said. Being pushed into that worrier role in their families or communities makes them more aware of risk than men.

In other words, women make decisions including health decisions based on what they think is best for themselves and everyone else they care for, which ultimately leads to more conservative choices. Men more often base decisions on their personal risk tolerance alone, which leads to riskier choices, Calarco said.

Leone calls it normative contentment.

Its kind of a self-fulfilling prophecy, he said. Men and boys are going to do things that are bad for their health and we just kind of accept that as part of our culture. Its almost like we give the social free pass to men and boys to just take off, and come to us when you have an issue.

Cultural norms aside, biology ultimately sets the stage, said Michigans Kruger. While the differences between males and females are not black-and-white, studies nevertheless have suggested that genetic predisposition plays a role in their varying penchants for risk.

The phenomenon dates back to our ancestors of ages ago, when men had to compete for partners in a way women didnt. Most women had children, but only the strongest men had partners. They used their physical strength to establish powerful leadership positions within their communities, and prevent other men from pairing up, he said.

There was a lot of incentive for competition, to get in those high-status, powerful positions where you can attract and retain mates, Kruger said. Theres a risk youll die without reproducing and a greater motivation to take risks to get there.

Our physical and social environments have, of course, changed dramatically. No one back then was scheduling doctors appointments or getting vaccines, and no modern American mans survival depends on his ability to physically fend off competitors and hunt down large animals for dinner. But mindset borne of that genetic legacy, he said, is still there.

When public health officials have sought to encourage public acceptance of vaccines, masks, and other pandemic safeguards, few if any of the messaging initiatives have been crafted with gender in mind.

But evidence from other health contexts shows it is possible to get men to be more health conscious, said Leone, who studies methods for improving health outcomes in under-served communities.

One possibility is terminology.

The term womens health is often tied up with the issues surrounding reproductive health and the health of offspring, whereas mens health, to the extent that it gets any lip service, is off in its own silo. The more inclusive term family health would send a message to men that they, too, must take care of themselves, Leone said.

But how to get the message across? It may sound simple, Leone said, but just getting men in the same room, talking about health topics that they may in the past have shied away from, can help.

In Australia, for example, men are encouraged to join community organizations called sheds, where they discuss healthy behaviors while partaking in such activities as woodworking and beekeeping.

In the U.S., some health care providers have demonstrated success by meeting men where they are, such as barbershops or sporting events, Leone said. Blood pressure screenings at football games and car shows are increasingly common in many states, for example. Or community breakfasts paired with cancer screenings, with catchy names such as Pancakes & Prostates.

READ MORE: Salons and barbershops can help get COVID-19 vaccines into arms | Opinion

A big part of the strategy is simply getting men to form new habits, Leone said.

Girls are taught to be proactive about their health, and as young women are encouraged to schedule routine gynecological exams. Young men, meanwhile, may have very little reason to see a doctor, so long as theyre healthy, he said. But if they establish a relationship with a trusted health care provider, men can get started on lifestyle changes that can reduce the risk of chronic disease years into the future.

Modeling behavior and social influence also can be powerful in shaping health behavior, said Indianas Calarco especially for men, who may be less threatened by exposing what they perceive as a weakness if someone else is doing the same.

For instance, research has found that when male executives do not take advantage of their companys parental leave policy, neither do new fathers lower in the organization.

The more other people are doing it, the more youre inclined to do it, she said. When you have high-status men engaging in a behavior, it can send a signal that its OK for other men to engage in that behavior, too.

Will any of this work with the highly politicized topic of COVID-19? Hard to say, though vaccine mandates may render the question, in many cases, moot.

Whats clear is that men and women are often of different minds when it comes to taking care of themselves, yet it is a problem that affects us all.

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Many men dont take good care of themselves. COVID-19 vaccine rates are the latest in a problem as old as medicine. - The Philadelphia Inquirer

Chicago Hits Goal As 77% Of Residents 12 And Older Have Gotten 1 Shot Of COVID-19 Vaccine – Block Club Chicago

November 23, 2021

CHICAGO The city has met its goal of getting 77 percent of residents 12 and older to get at least one shot of a COVID-19 vaccine.

City officials set that goal in late September, noting 77 percent would not be some magic number related to herd immunity but it is symbolic of Chicagos 77 community areas.

As of Monday, the citys hit that goal, according to city data though officials speaking at a news conference said Chicago actually has only vaccinated 76.7 percent of residents 12 and older and wont hit the goal until later in the week.

Its an incredible accomplishment, Mayor Lori Lightfoot said at a Monday news conference.

Dr. Jennifer Seo, chief medical officer at the citys health department, said the milestone is a testament to the hard done by community groups and residents to get people vaccinated and protect the city.

Now is the time to get vaccinated not only to protect us for the winter and holiday seasons, but to also continue to move us forward out of this pandemic, Seo said.

The milestone comes as health leaders, officials and experts are urging people to get vaccinated and get booster shots before holiday gatherings. Cases have risen sharply in Chicago, and new surges have formed across the upper Midwest.

The vast majority of new cases, hospitalizations and deaths are in unvaccinated people, officials have said.

Everyone 5 and older is eligible to get vaccinated in Chicago.

COVID-19 vaccinations are free and do not require insurance. Anyone can call the citys coronavirus hotline at 312-746-4835 to get more information on how and where to get vaccinated in their community.

Chicagos stretch goal is getting 77 percent of residents 12 and older fully vaccinated, Dr. Allison Arwady, head of the Chicago Department of Public Health, said when announcing the goal in September. As of Monday, 70.3 percent of those residents have hit that mark.

Block Club Chicagos coronavirus coverage is free for all readers.

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Chicago Hits Goal As 77% Of Residents 12 And Older Have Gotten 1 Shot Of COVID-19 Vaccine - Block Club Chicago

New UMass Amherst/WCVB poll on children being vaccinated against COVID-19 – WCVB Boston

November 23, 2021

New UMass Amherst/WCVB poll on children being vaccinated against COVID-19

Updated: 8:20 PM EST Nov 22, 2021

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ALREADY GOTTEN THE SHOFOT R THE KIDS OR PLAN T REPORTER: 'S AIT TOUGH DECISIONER MANY FAMILIES. >> IT'S VERY HD.AR UYO NEVER KNOW. REPORTER: HOW DO YOU FEEL ABOUT GETTING IT FOR YROU GRANDSON? NEW UMASS POLL SWSHO 54% OF PARENT HAVE ALREADY GOTTEN THE SHOTS FOR THEIR KIDS OR PLAN TO. CHILDREN VACCINATED. 15% DID NOT ANSWER, FOR REASONS SUCH AS THEIR CHILDREN AS STILL TOO YOUNG. BUT UMASS AMHERST POLITALIC SCIENCE PROFESSOR JESSE RHODES SAYS MANY PARENTS WANT TO GO EVEN FURTH.ER >> A STRGON MAJORITY OF MASSACHUSETTS PARENTS WOULD BE SUPPORTIVE O AF VACCINE MANDATE FOR CHILDREN IN12 SCHOOLS. REPORTER: ACCORDING TO THE POLL 59% OF PARENTS STRONGLY OR SOMEWHAT SUPPORT VACCINE MANDATESOR F PUBLIC SCHOOL STUDENTS WITH CERTAIN EXEMPTIONS. 12% ARE ON THE FENCE. AND 28% STRONGLY OR SOMEATWH OPPOSE SCHOOL MANDATES. >> I WOULD LEAN ON THE SIDE OF SAYING TTHA MAKES SENSE. REPORTER: PUBLIC HEALTH EXPERT STEPHEN KISSLER SAYS PARENTS AND POLICY-MAKERS SHOULD REMEMBER.TH WIDESPREAD KIDS ARE GOING TO BE EXPOSED ONE WAY OR THE OTHER. >> THEY ARE GOING TOET G THEIR FIRST EXPUROSE FROM THE VACCINE OR THE VIRUS ITSELF. WE KNOW FROM ALL THE DAAT THAT WE HEAV AVAILABLE, THAT EXPOSING THEM THROUGH THE VACCINE ISSTILL REPORTER: WE ASKED ABOUT THE MASK MANDATES. PARENTS SUPPORT THE IDEA OF DROPPING THOSE MASK MANDATES AS SOON AS THE SCH

New UMass Amherst/WCVB poll on children being vaccinated against COVID-19

Updated: 8:20 PM EST Nov 22, 2021

This poll is one of our first glimpses into how Massachusetts parents are thinking about not only getting vaccines for their own children, but also their children's classmates.

This poll is one of our first glimpses into how Massachusetts parents are thinking about not only getting vaccines for their own children, but also their children's classmates.

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New UMass Amherst/WCVB poll on children being vaccinated against COVID-19 - WCVB Boston

Why Moderna wont share rights to the COVID-19 vaccine with the government that paid for its development – KRQE News 13

November 21, 2021

(THE CONVERSATION) A quietmonthslong legal fightbetween the U.S. National Institutes of Health and drugmaker Moderna over COVID-19 vaccine patents recently burst into public view. The outcome of the battle has important implications, not only for efforts to contain the pandemic but more broadly for drugs and vaccines that could be critical for future public health crises.

Moderna recentlyoffered to share ownershipof its main patent with the government to resolve the dispute. Whether or not this is enough to satisfy the governments claims, I believe the dispute points to serious problems in the ways U.S. companies bring drugs and vaccines to market.

US was a major funder of the Moderna vaccine

Vaccines haveplayed a crucial rolein the response to the pandemic.

In December 2020, Moderna became the second pharmaceutical company after Pfizer toobtain authorizationfrom the Food and Drug Administration to market a COVID-19 vaccine in the United States. People have since grown so used to talking about the Moderna vaccine that a crucial element in the history of how it was developed risks being overshadowed: Moderna wasnot the sole developerof the vaccine.

Unlike many of the other pharmaceutical companies involved in theCOVID-19 vaccine race, Moderna is a newcomer to drug and vaccine commercialization. Founded in Massachusetts in 2010, the company hadnever brought a product to marketuntil the FDA authorized its COVID-19 vaccine last year.

Throughout the 2010s, Moderna focused on the development ofmRNA technology, attracting overUS$2 billion in fundingfrom pharmaceutical companies and other investors.It went publicin 2018.

Evenbefore the pandemic, research on both coronaviruses and vaccine candidates against emerging pathogens was a priority for agencies operating in the public health space. In 2015, theNational Institute of Allergy and Infectious Diseases, an institute within the NIH,signed a cooperative R&D agreementwith Moderna on basic research, including the development of new vaccines. The agreement resulted in anundisclosed amount of fundingand assistance with research.

In addition, after the COVID-19 outbreak began Moderna alsoreceived almost $1 billioninfundingfrom theBiomedical Advanced Research and Development Authority, which operates within the Department of Health and Human Services. This funding was specifically targeted to the development of a COVID-19 vaccine candidate.

Researchers have calculated that, collectively, the U.S. governmenthas provided $2.5 billiontoward the development and commercialization of Modernas COVID-19 vaccine.

US, Moderna scientists working side by side

In addition to providing financial support, the federal government was instrumental in the development of Modernas vaccine for other reasons. Namely, federal scientists worked alongside Moderna scientists on different components of the vaccine.

These contributions includedworking on dosing mechanisms, and the NIH said federal scientists created thestabilized spike proteinsthat are a key component of the vaccine made by Moderna.

The importance of the role played by federal scientists in their work with Moderna would soon become apparent. A2019 agreementwith a third party explicitly acknowledged this, alluding to mRNA vaccine candidates developed and jointly owned by NIAID and Moderna. And by late 2020, the U.S. government was calling it the NIH-Moderna COVID-19 vaccine.

While the U.S. government has spent money onCOVID-19 vaccinesmade by other companies, its close involvement in the R&D stages of Modernas sets it apart.

How it became a patent dispute

As development of the vaccine progressed, Moderna applied forseveral patents, each one covering different components of the vaccine. U.S. law allows inventors to apply for patents on products or methods that arenew, not obvious and useful. While some early modern vaccines like thepolio vaccinedeveloped by Jonas Salks team werenot coveredby patents, from the late 20th century onwardit became very commonfor one or multiple patents to cover a newly developed vaccine.

In applying for some patents related to its vaccine, Moderna named National Institute of Allergy and Infectious Diseases scientists as co-inventors alongside Moderna scientists. This was the case, for example, in apatent applicationdated May 2020 for a relatively minor component of the vaccine.

However, in July 2021, Moderna made it clear that it would not name government scientists as co-inventors in apatent applicationcovering a much more significant component of the vaccine: the mRNA sequence used to produce the vaccine, known as mRNA-1273.

Modernas position was thatModerna scientists alonehad selected the sequence. Thecompany informedthe Patent and Trademark Office of its position in a 2020 statement.

In November 2021, government officials publicly challenged the companys decision after months offailed negotiationswith the company. Moderna thentook to social mediato defend its position, tweeting:

Just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine.

By contrast, the National Institutes of Healthargued that three NIAID scientists Kizzmekia Corbett, Barney Graham and John Mascola had meaningfully contributed to the invention, thoughtheyve declinedtopublicly specify how. If true, patent law says theyshould be named co-inventors.

But this dispute is not merely about scientific principles or technical aspects of the law. While patents are also regarded as proxies for measuring scientific reputation, their most immediate and powerful effect is to give patent holders asignificant amount of controlover the covered technology in this case, the main component of the vaccine made by Moderna.

From a practical perspective, excluding federal scientists from the application means that Moderna alone gets to decide how to use the vaccine, whether to license it and to whom. If, by contrast, the government co-owns the vaccine,federal patent law allowseach of the joint owners to engage in a variety of actions from making and selling the vaccine to licensing it without the consent of the other owners.

This is especially relevant in cases of product scarcity or potential pricing issues in connection with the commercialization of the vaccine. For instance, the U.S.would have the abilityto allow more manufacturers to produce vaccines using the mRNA-1273 technology. In addition, it could direct vaccine doses wherever it likes, including tolower-income countries that have received few vaccines so far.

Broader implications

The ongoing battle between the government and an emerging star in the pharmaceutical industry is yet another episode in a complicated relationship between actors with complementary yet distinct roles in the production of drugs and vaccines.

On the one hand, the federal governmenthas long played a critical rolein both performing and funding basic research. On the other, it does not have the resources and capacity to bring most types of new drugs and vaccines to market on its own.

The pharmaceutical industry thus plays an important and necessary role in drug innovation, which I believe should be rewarded although not boundlessly.

If the NIH is correct about co-ownership of the vaccine, then Moderna is unduly using a legal tool to achieve a position of market control a reward it does not deserve. This position of sole control becomes even more problematic in light of the significant amounts of public money that funded the development of this vaccine. This offset some of Modernas financial risk, even as thecompany projectsto make $15 billion to $18 billion in revenue from vaccine sales in 2021 alone, with much more expected in 2022.

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However, even if the NIH prevails in the patent dispute, it is important to understand the limitations of such a win. The U.S. would be in a position to license the vaccine, for example, and could do so by requiring that licensees agree to equitable distribution of vaccine doses.

But co-ownership would not enable the government to fix any of theother problemsthat currently affect the manufacturing and distribution of COVID-19 vaccines, such as scaling up production or building infrastructure to deliver vaccine doses.

In my view, the dispute is a reminder of themanyproblemsembedded in how vaccines are made and delivered in the U.S. And it shows that when taxpayers fund basic research of a drug, they deserve more of the control and rewards when that drug succeeds.

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Why Moderna wont share rights to the COVID-19 vaccine with the government that paid for its development - KRQE News 13

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