Category: Covid-19 Vaccine

Is a mandate a law? How will Biden's vaccine mandate be enforced?

Republican governors have threatened lawsuits, but the employers affected by the mandate hold the most ground to sue.

Staff video, USA TODAY

The U.S. reached an encouraging milestoneWednesday with 80% of Americans ages 12 and older having received at least one dose of a coronavirus vaccine, President Joe Biden'scoronavirus response coordinator said.

Jeff Zients, speaking at a White House briefing,estimated that in the last 10 days at least 2.6 million kids ages 5-11 have received their first shot, about 10% of the children that age in the country. He said it took about 50 days to reach 10% of adults, who make up a much larger number.

"We know there is more work to do," Zients said. "But these milestones represent critical progress and shows we are on the right track in our fight against the virus."

The U.S. will invest billions of dollars into vaccine manufacturing capacity with the goal of producing at least one billion doses a year, Zients said.The goal is to be prepared to roll out a vaccine for future pathogens within nine months of an outbreak, hesaid. The investment, first reported in the New York Times,calls for the government to partner with industry to address immediate vaccine needs at home and abroad and to prepare for future pandemics.

Zients said the U.S. alreadyhas provided 250 million vaccine doses to 110 countries "for free, no strings attached."

Also in the news:

A Los Angeles County couple who cut off their tracking bracelets and fled after being convicted of stealing $20 million in COVID-19 relief funds were sentenced in absentiato years in federal prison.Richard Ayvazyan, 43, was sentenced to 17 years and his wife, Marietta Terabelian, 37, got six years, according to a statement from the U.S. attorneys office. They remain fugitives.

The Occupational Safety and Health Administration (OSHA) said on its website that it has "suspended activities related to the implementation and enforcement'' of President Joe Biden's mandate that companies with 100 employees or more require COVID vaccination or testing. Biden's order has been stayed by a U.S. court of appeals.

"Dancing With The Stars"judgeDerek Houghhas tested positive for COVID-19 ahead of the show's finale.

A health clinic in the San Francisco Bay Area city of Antioch gave 14 children under age 12 the wrong dose of the COVID-19 vaccineover the weekend, raising a furor among parents.

Today's numbers:The U.S. has recorded more than 47 million confirmed COVID-19 cases and more than767,000 deaths,accordingtoJohns Hopkins Universitydata. Global totals: More than 254.8million cases and 5.1 million deaths. More than 195.6 million Americans 58.9% of the populationare fully vaccinated,according to theCDC.

What we're reading:Its time to reassess expectations for reading skills of children whose early learning was disrupted by the pandemic. And thats OK, expertssay.

Keep refreshing this page for the latest news. Want more?Sign up forUSA TODAY's Coronavirus Watch newsletterto receive updates directly to your inbox, andjoin ourFacebook group.

For much of the pandemic, some Americans fearful of contracting COVID-19 have steered clear of elevators and opted for the stairs. Arecent report suggests elevators likely aren't a high source of coronavirus transmission.

Purdue University researchers simulated airborne particle exposure for people riding a typical elevator with a person who is infected with COVID-19, according to the study published last week in the peer-reviewed journal Building and Environment and commissioned by Otis Elevator.

Researchers ran seven simulations that analyzed different airflow directions and ventilation rates.In each simulation, the elevator began at the ground floor with six passengers and made two stops at the 10th and 20th floors before reaching the 35th floor. The person infected with COVID-19 made the whole trip to the top floor, but in one simulation, the individualcoughed upon entering the elevator.

Researchers determined that due to the short trip duration and high ventilation rate, there is low risk of COVID-19 transmission in elevators. Although the study analyzed particle concentration, air flow and exposure, study authors say more research is needed to account for other factors and one should not neglect the impact of exposure.

Adrianna Rodriguez

Michigan catapulted Tuesday to theworst COVID-19 hot spot in the nation, as the seven-day case rate rose to 503.8 per 100,000 residents, according to the CDC.Cases are rising in 33 states, a USA TODAY analysis of Johns Hopkins University data shows. Cases for the week ending Monday were at 584,449, up 15% from a recent low in the week ending Oct. 26.

Michigan hospitals say they're feeling the pressure as the number of COVID-19 patients has climbed nearly 50% in the last month from 2,097 admitted Oct. 18 to 3,082 on Monday,according to state data.

"We have both this stark surge of COVID-19 patients, but we also have hospitals that have been dealing with staffing challenges and staffing shortages, as well as high volumes of non-COVID patients,"said John Karasinski, a spokesman for the Michigan Health and Hospital Association, which represents all 133 community hospitals in the state.

That means potentially long waits at emergency rooms, hospitals that have to postpone non-emergency medical procedures and some that can't accept new patient transfers, he said.Most COVID-related hospitalizations and deaths both in Michigan and nationwide are among the unvaccinated.

Kristen Jordan Shamus, Detroit Free Press

Moderna has once again asked the Food and Drug Administration for emergency use authorization of itsCOVID-19 booster shot for all U.S. adults, just as Pfizer is expected to get such clearance this week.

As Moderna noted in a statement Wednesday, the FDA has already granted its booster authorization for seniors 65 and older, for the immunocompromised andfor those whose living or work conditions may put them at high risk of exposure to the virus. But the agency has yet to clear the Moderna booster for everybody ages 18 and older.

Also Wednesday, Moderna requested authorization fromHealth Canada for its COVID-19 vaccine for children ages 6-11.

A physician has resigned from Houston Methodistdays after the hospital suspended her and accused her ofspreading misinformation about COVID-19 on social media.

The hospital temporarily revoked Dr. Mary Bowdens hospital privileges Friday, citing unprofessional behavior" after Bowden repeatedly decried vaccine mandates and promoted ivermectin, the anti-parasitic drug that federal health officials have not approved for treatingthe virus.

In her resignation letter she describedvaccination as an "important tool" in the pandemic fight. Bowden, an ears, nose and throat specialist,denies spreading misinformationbut said doctors "should pay more attention to medications such as ivermectin."

The FDA in a September notice wrote that "currently available data do not show ivermectin is effective against COVID-19." The agency said it hadreceived "multiple reports" of patients who have required medical attention after self-medicating with ivermectin. Clinical trials were ongoing.

A second set of states has filed a federal lawsuit challenging the Biden administration's COVID-19 vaccine mandate for health care workers.The most recent suit, dated Monday, was filed in Louisiana on behalf of 12 states and comes less than a week after another lawsuit challenging the rule wasfiled in Missourirepresenting 10 states.

Both lawsuits say the vaccine mandate threatens to drive away health care workers who don't want toget vaccinated at a time when such workers are badly needed. They also contend the rule issued by the Centers for Medicare and Medicaid Services violates federal law and unconstitutionally encroaches on states' powers.The Biden administration has not yet filed responses in either of the suits.

The New Orleans-based 5th U.S. Circuit Court of Appeals on Fridayblocked a broader Biden administration vaccine mandate that businesses with more than 100 workers require employees to be vaccinated by Jan. 4 or wear masks and be tested weekly for COVID-19.

The pandemic has spurred many workers to reevaluate their livesand the role work plays in them, leading some to set fresh boundaries,find new jobs or maintain the side gigs that got them through the shutdowns and layoffs.Nearly sixin 10 American workersin an October survey by job search site LinkedInsaid they had gone through acareer awakening during the COVID-19 pandemic, whether it was a desire for better work-life balance, deciding to pursue apromotion or redefining their meaning of success.

The survey also found a majority of American workers who say the pandemic has altered the way they feel about their career.

"Were seeing that lack of fulfillment, motivating people to make changes, whether theyre looking for a new job, a new career or picking up a side hustle,'' says Catherine Fisher, LinkedIn's career expert.

Charisse Jones

Federal authorities are charging a Texas woman with interfering with an aircraft after a clash over a mask duringa flight from Alaska to San Francisco. Debby Dutton faces up to20 years if convicted.

According to the criminal complaint, Dutton and her husband were passengers on board aUnited Airlines flight June 29 whena flight attendant noticed the face mask being worn by Dutton's husband, who was asleep, had fallen off. When the flight attendant tapped the man's shoulder and asked him to put his mask back on, authorities say Dutton began shouting and pushing the flight attendant.

Dutton is being charged with one count of interference of a flight crew or attendants by assault,threator intimidation.

Jordan Mendoza

Contributing: The Associated Press

Excerpt from:

80% of Americans 12 and over have first dose; Michigan is nation's hot spot as infections rise in 33 states: COVID-19 updates - USA TODAY

WASHINGTON Right-wing politicians resistance to vaccine mandates is extending far beyond Covid-19 immunizations, a startling new development that carries vast implications for the future of public health.

In Idaho, a lawmaker introduced a bill that would define vaccine mandates of any kind as a form of assault. In Florida, a prominent state senator has called for a review of all vaccine requirements, including those for immunizations that have enjoyed wide public acceptance for decades, like polio and the measles, mumps, and rubella shot. And in Montana, the Republican governor recently signed into law a new bill that forbids businesses, including hospitals, from enforcing any vaccination requirements as a condition of employment.

The bills represent the latest wave of resistance to the Biden administrations push to impose Covid-19 vaccine mandates for nearly all Americans. But the new, across-the-board revolt against vaccine requirements of any kind, experts told STAT, could begin to reverse a century of progress against diseases that, thanks to vaccines, are afterthoughts to most Americans.

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If you [challenge] all of the childhood vaccinations that are required, we could be in a really serious situation with outbreaks of diseases that long ago should have been eliminated in our society. We just cant have that, said Anthony Fauci, the government researcher and chief medical adviser to the Biden administrations pandemic response, in a Tuesday interview at the 2021 STAT Summit.

In many cases, right-wing legislators resistance to vaccine mandates has been cloaked in rhetoric specific to Covid-19 immunizations. Upon closer reading, however, many of the proposals they have floated some of which have already been signed into law apply to all vaccines, not just the three currently authorized in the U.S. to prevent Covid.

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A Tennessee proposal banning employer vaccine mandates, for one, doesnt specify which immunizations it would apply to, meaning it effectively would apply to any requirement. Alabamas GOP governor recently signed a new law banning any new vaccine mandates in schools, beyond those that already exist a measure clearly aimed at Covid but with a potential impact on future immunization efforts.

Public health departments have a tough enough time vaccinating the public even with the benefit of existing laws that support mandates, said Lily Kan, the senior director for infectious diseases and informatics at the National Association of County and City Health Officials. When lawmakers step in to nullify those mandates, she added, that task becomes even more difficult.

When theres a direct lack of trust based on misinformation, disinformation, and active efforts to undermine vaccination rates, thats really concerning, she said. We dont want people to think that not getting vaccinated can be the norm.

The assorted lawmakers push to effectively ban vaccine mandates altogether comes amid a dual crisis. Most pressing is the ongoing pandemic: The U.S. is still recording well over 1,000 Covid-19 deaths each day, and roughly 18% of the countrys adults remain unvaccinated.

Now, public health experts are beginning to express open alarm about plummeting childhood vaccination rates. In part, they stem from the pandemic itself: Many parents who have worked from home and whose children have attended school remotely have simply made fewer trips into doctors offices for fear of Covid-19 exposure.

In 2020, the World Health Organizations reported that across the globe, childhood immunization rates dropped from 86% to 83%. Roughly 23 million babies didnt receive basic vaccines normally given, the highest number since 2009.

Even before the pandemic, there were worrying signs that we were beginning to lose ground in the fight to immunize children against preventable child illness, including with the widespread measles outbreaks two years ago, Henrietta Fore, UNICEFs executive director, said in a recent statement. The pandemic has made a bad situation worse.

Increasingly, though, those low vaccination rates may also be driven by turbocharged vaccine skepticism and outright misinformation that has clouded parents judgment.

Even before Covid-19, some U.S. communities had begun to experience outbreaks of diseases that most of the country has largely eradicated. In two recent high-profile instances, a Somali-American community in Minnesota and a largely Orthodox Jewish town outside New York City experienced major measles clusters in 2017 and 2019, respectively. In both cases, the outbreaks were driven by lower-than-ideal vaccination rates, which in turn stemmed from active misinformation campaigns.

The new wave of resistance to vaccine mandates of any type, however, marks the start of a completely new era of vaccine politics.

There are real conversations to be had about individual liberty versus public health, government overreach, all of that stuff, said Nahid Bhadelia, a physician-researcher who leads the Center for Emerging Infectious Diseases Policy and Research at Boston University. But the level to which this has been politicized its on purpose, and its toward the goal of continuing to create strife around the pandemic.

Still, other experts have warned that governments should factor in inevitable backlash when imposing requirements for Covid-19 vaccines and other immunizations. In situations where most of the population is already vaccinated, sweeping mandates could do more harm than good in the long run, argued Scott Gottlieb, the former Food and Drug Administration commissioner and Pfizer board member.

The risk is [that] organized opposition to this OSHA mandate starts to bleed into broader opposition to vaccination and vaccine mandates more generally, and mandates society long embraced become part of this new political fashion, he wrote this month on Twitter, referring to the Biden administrations recent requirement that large companies must mandate their employees to be either vaccinated against Covid or tested weekly. And a whole generation starts to turn against vaccines.

But an anti-vaccine generation might already be the reality. According to one recent poll, the partisan divide over Covid-19 vaccination has crept into the countrys annual flu vaccination campaign.

In 2020, one AP-NORC poll showed just a 4% gap between Democrats and Republicans desire to be immunized against the flu. Two surveys conducted in 2021, however, paint a grimmer picture: Now, Democrats are more enthusiastic than Republicans about flu vaccines by a 24% or 25% margin, according to Axios/Ipsos and Kaiser Family Foundation, respectively.

Its the perfect storm, because theres growing vaccine hesitancy, an anti-vax lobby growing more powerful, and this growing milieu of disinformation, Bhadelia said. There is a general societal movement here in the U.S. to undermine public health recommendations.

Read the rest here:

GOP opposition to vaccine mandates extends far beyond Covid-19 - STAT

SAGINAW, MI Thirty-seven children between the ages of 5 and 11 were vaccinated at the first Saginaw-based clinic scheduled outside of traditional school hours, officials said.

Great Lakes Bay Health Centers hosted the event the evening of Wednesday, Nov. 17, at its facility at 229 Gallagher in Saginaw.

The vaccination event featured prizes, gift cards and giveaways for children. Even the medical kits took on a kid-friendly feel: Staff used small Hulk-themed bandages to cover the injection punctures on each childs shoulder.

Health care providers across the U.S. earlier this month began vaccinating children from ages 5 to 11 after officials authorized COVID-19 vaccines for the age group.

In studies of approximately 3,100 children, the vaccine was found to be 90.7% effective in preventing COVID-19 in people ages 5 to 11. No serious side effects have been detected, according to the U.S. Food and Drug Administration.

To answer some of the most frequently asked questions related to youth vaccinations, MLive hosted a live chat last week with a pair of experts in the field.

Reporter Justin P. Hicks was joined by Dr. Natasha Bagdasarian, chief medical executive for the state of Michigan, and Dr. Rosemary Olivero, a pediatric infectious disease specialist at Helen DeVos Childrens Hospital in Grand Rapids.

Below is a video of their talk:

Related news:

Why should kids get vaccinated against COVID-19, and other questions answered by Michigan doctors

COVID vaccine side effects: Most common reactions for kids ages 5 to 11, according to FDA

Michigan reports 2-day total of 14,561 new COVID cases and 242 deaths on Wednesday, Nov. 17

See the original post here:

Hulk bandages and tough kids: COVID-19 vaccine clinic for children held in Saginaw - mlive.com

RALEIGH, N.C. (WNCN) The Center for Disease Control and Prevention has made vaccinations front and center for its holiday safety recommendations.

The CDC said the best way to protect everyone, regardless of age, is getting vaccinated against COVID-19.

To protect people not yet eligible, such as those under the age of 5, the agency said making sure everyone around them is vaccinated is key.

So when is your last chance to get fully vaccinated for the holidays?

For Thanksgiving, its too late.

Fully vaccinated is defined as two weeks after your second dose of the Moderna or Pfizer vaccine and two weeks after your Johnson and Johnson shot.

There is time to be fully vaccinated by Christmas if you opt for the Johnson and Johnson vaccine. You can get full protection from the one-dose regimen if youre vaccinated by Dec. 10. That will give just enough time to build up enough immunity for Christmas Eve.

For those opting for the Pfizer vaccine, the first dose cut off for Christmas Eve would be Friday, Nov. 19. That would put your second dose at Dec. 10 making you fulling vaccinated on Dec. 24.

Modernas second dose is administered 28 days after the first. Even if you got your first dose as early as Friday, Nov. 19, you wouldnt be fully vaccinated by Christmas, but you would be pretty close to getting there.

Some protection is better than nothing at all.

If youre not fully vaccinated, the CDC recommended wearing a well-fitted mask in an indoor setting. If you are vaccinated but live in a high transmission area, CDC officials recommend also wearing a mask.

The CDC noted outdoor settings were safer than indoor.

The CDC noted that if someone in your household has a weakened immune system, is at increased risk for severe disease, or is unvaccinated, it might still be a good idea to wear a mask even if youre vaccinated.

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Heres when you need to get each of the COVID-19 vaccines to have immunity for the holidays - CBS17.com

An agreement to waive the intellectual-property rights underpinning Covid-19 vaccinesa prospect poor countries have hoped would ease supplies to the developing worldis becoming increasingly unlikely, say people familiar with the situation, with the U.S. not acting to bridge disagreements between developing world countries and those opposing such a measure.

In May, the Biden administration said it would support temporarily suspending patents and other IP linked to the shots to allow developing countries to produce the Covid-19 vaccines created by big drug companies.

Here is the original post:

Prospects of Intellectual-Property Waiver on Covid-19 Vaccines Fade - The Wall Street Journal

A Yale-led study reveals that low- and middle-income countries that hosted clinical trials for COVID-19 vaccines are receiving proportionately fewer doses of these vaccines, suggesting that there are wealth-based disparities in COVID-19 vaccine access among countries that participate in testing.

The study, published Nov. 18 in JAMA Network Open, examines access in terms of regulatory authorization or approval as well as delivery of six unique COVID-19 vaccines listed for emergency use by the World Health Organization (WHO) as of Sept. 7, 2021. Clinical trials for these vaccines were completed in 25 countries and are currently ongoing in an additional 12 countries.

In an analysis of both completed and ongoing clinical trials for WHO-recommended COVID-19 vaccines across 37 countries, the researchers found that more than 90% of the tested vaccines had been authorized for use as of early September. They also found that over 90% of the countries that hosted clinical trials for COVID-19 vaccines had doses of tested vaccines delivered. However, among countries hosting completed clinical trials, high-income countries received enough doses to vaccinate a median 51.7% of their population ages 15 years and older compared with rates of 31% and 14.9% in low- and middle-income countries, respectively.

These wealth-based disparities weve found among countries whose populations have participated in testing of these vaccines reflect the broader disparities in COVID-19 vaccine access that were seeing worldwide, says Dr. Reshma Ramachandran, a National Clinician Scholar at Yale School of Medicine and the studys lead author. As many lower income countries continue to experience inequitable shortfalls in COVID-19 vaccine supply amid the ongoing pandemic, efforts must be undertaken to ensure timely access to all countries, regardless of income group, including those hosting clinical trials.

The researchers also identified significant variation in the number of countries that hosted completed clinical trials for the different vaccines. Two high-income countries participated in testing for the COVID-19 vaccine manufactured by Moderna, while 9, 10, and 14 middle- and high-income countries hosted trials for vaccines manufactured by Pfizer, Johnson & Johnson, and AstraZeneca/Serum Institute of India, respectively. With the exception of AstraZeneca/Serum Institute of India, high-income countries that hosted completed clinical trials for all other manufacturers received more doses to vaccinate larger median proportions of their populations.

Appropriately including low- and middle-income countries in research is an important goal, particularly when an experimental medicine or vaccine targets a disease or condition burdening a country, like COVID-19. However, inclusion must correspond with fair access to the benefits of research, otherwise it can be exploitation, said Jennifer E. Miller, an assistant professor at Yale School of Medicine and co-author of the study.

The authors also examined vaccine access in countries hosting clinical trials through COVAX, a global initiative co-led by the nonprofit Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO, which aims to make COVID-19 vaccines and other health technologies more accessible in low- and middle-income countries. They found that, as of early September, COVAX has delivered a much larger proportion of procured doses to upper middle-income countries (78.8%) than low- (15.4%) and lower middle-income (38.8%) countries that tested these same vaccines.

Data for this study were extracted from the Airfinity COVID-19 platform and generously provided by Anthony Kamande and Max Lawson of Oxfam International, a member organization of the Peoples Vaccine Alliance.

View original post here:

Inequitable access to COVID-19 vaccines among countries that hosted trials - Yale News

RAPID CITY, S.D. (KELO) The COVID-19 pandemic has become dj vu for Dr. Shankar Kurra.

Kurra, the vice president of medical affairs at Monument Health, is back asking the public to help flatten the curve when it comes to the COVID-19 pandemic.

In Monuments main Rapid City hospital, there are 56 COVID-19 patients in hospital beds, 15 in the ICU and 13 on ventilators. With full hospitals, cases and positivity rates rising again, Kurra said more people need to choose to become vaccinated against COVID-19 to assist local hospitals.

Were already at capacity in the ICUs in the hospital. The only way we can kind of manage this is to get vaccinated so we can slow down and flatten the transmission curve, Kurra said. What we want to avoid in South Dakota is a crisis standard of care situation. The only way you can do that is by vaccination. Vaccination completely suppressed transmission.

As of Thursday, the South Dakota Department of Health reports 70% of the population, age 12 or older, have received at least one dose of the vaccine, while only 58%, age 12 or older, is fully vaccinated. Kurra pointed out the Centers for Disease Control and Prevention lists 69% of the United States population, age 12 or older, is fully vaccinated.

The groups that go to work and go to school are currently under vaccinated, said Kurra, who added the age groups throughout 18 to 50 are 40-50% vaccinated.

With South Dakota trailing the national average for vaccinations, Kurra said theres more opportunity for the coronavirus to transmit. He also said South Dakotas rural makeup creates drastic variables in vaccinations county by county.

As long as you have counties (with large unvaccinated populations), and theres several of them, thats half the population susceptible to the virus, Kurra said. That will be a perfect stage for the next wave.

Kurra said he expects a winter surge and more upticks in COVID-19 cases throughout the months of December, January and February.

Each of the waves are directly related to our human behaviors, Kurra said. Anytime you see an upward trend, there are two things going on. No. 1 its human behaviors and No. 2 is vaccination. The virus itself doesnt drive these waves; its people. The biggest one is the vaccine. Thats the best way to suppress spread.

Until the pandemic chapter of COVID-19 finishes, Kurra said health systems have to remain prepared for large influxes of new patients. Hes optimistic the vaccine now being available for kids aged 5-11 will help get more of the total population to 70% vaccinated against the virus.

Thats a big impact. These kids that go to school are very effective transmitters of the disease, Kurra said.

With more age groups eligible, Kurra still stressed people in all age groups from 5 to 50 need to reach 70% vaccination until COVID-19 can be considered to be more endemic.

Then well stop seeing more waves, Kurra said. The only reason we see waves is because we dont have enough vaccination rates.

With Thanksgiving, Christmas, New Years Eve and New Years Day approaching, discussions between family and friends on the COVID-19 vaccine may happen.

Kurra emphasized choices to become vaccinated or not are rational choices.

You have to meet people at where they are in life, Kurra said. My advice for everyone would to engage in a conversation with empathy.

Kurra said hes noticed when people see a neighbor or close friend affected by the disease, theyre more likely to listen.

If we show empathy and understanding of why people chose not to vaccinated, given how bad things are today, I think we can get folks to vaccinated, Kurra said. I dont believe in tough conversations that actually push people away and show a lack of empathy and understanding.

Continued here:

Monument Health concerned as S.D. trails national average for COVID-19 vaccinations - KELOLAND.com

Papua New Guinea (PNG) is, economically, one of the poorest countries in Asia-Pacific, with significant human development challenges. Its health infrastructure is run-down. Approximately 85% of the country live outside of the cities, and moving around the country is extremely difficult. Until relatively recently, the biggest impact of COVID-19 on the country had been economic. However, in recent months the Delta variant of the virus has taken off. Health services are being overwhelmed and, although data are patchy, reports suggest rapidly rising deaths.

COVID-19 vaccination rates are low in PNG; in fact, some of if not, the lowest in East Asia Pacific. Supply of vaccines was an issue at first, and issues with health infrastructure are an ongoing problem. But news reports, as well as a series of smaller studies, have pointed to vaccine hesitancy as a serious impediment to vaccination uptake too.

In late May 2021, our team began research to find out just how prevalent COVID-19 vaccine hesitancy was in Papua New Guinea. We also sought to learn more about potential drivers of vaccine hesitancy, and how it might be reduced.

This research involved adding questions to an existing World Bank phone survey and conducting a separate online experiment. Both samples were large (2533 for the survey; 2392 for the experiment). However, neither cell-phone use, nor access to the internet are universal in Papua New Guinea. These facts posed a challenge; however, as we detail in our new World Bank discussion paper; the challenge wasnt insurmountable. Weighting, drawing on the most recent Demographic and Health Survey and census, allowed us to produce findings that were more representative of the population. Broadly representative is far from perfect, but in the middle of a pandemic, in a remote country where surveys are extremely difficult to deliver, our approach was the most feasible way of answering questions that are increasingly urgent.

The bad news from the phone survey is that vaccine hesitancy is high in Papua New Guinea. Less than one in five respondents who were aware a vaccine exists said they were planning to be vaccinated against Covid-19. These numbers indicate that PNGs vaccine hesitancy is potentially some of the highest in East Asia Pacific; at least it was when the survey was conducted in May and June; before the current outbreak which has now claimed many hundreds of lives.

Responses to phone survey question (May/June 2021) on whether participant was planning to be vaccinated

In theory, people might simply have had practical reasons for not planning to be vaccinated, such as difficulty accessing vaccines. However, when our team asked participants why they werent willing to be vaccinated, by far the most common answers were to do with the vaccine: fear of side-effects, or distrust in it.

Responses to phone survey question about why participant was not planning to be vaccinated

Note: multiple responses were allowed to this question, hence percentages total to more than 100.

Although online misinformation has been an issue over the course of the pandemic in Papua New Guinea, survey results suggest participants vaccine hesitancy didnt seem to be coming directly from the internet, with only a small proportion of respondents to the phone survey said they used the internet for health information. And there was no correlation between peoples trust in information from the internet and their willingness to be vaccinated against COVID-19. Certainly, internet misinformation might still be affecting peoples views about vaccines indirectly in PNG, with rumours starting online before subsequently being propelled by word-of-mouth. But the internet on its own does not seem to be primary driver of vaccine aversion.

Respondents to the phone survey were, unquestionably, worried about the vaccine. Yet other responses suggested their views might possibly be changed. When respondents that did not plan on being vaccinated, or who were unsure, were asked what type of person, if anyone, might change their mind, many stated that they would listen to health professionals. In another question we asked respondents about their preferred means of receiving vaccine information; with more than 80 percent saying they preferred face to face communication with health workers.

People who could change respondents minds about getting the vaccine (phone survey)

Note: multiple responses were allowed to this question, hence percentages total to more than 100.

Results from the online survey experiment confirmed that peoples views about the vaccine could, indeed, be changed. In the survey experiment, participants were randomly allocated to either the control group, which received no information about COVID-19 vaccines, or three treatment groups, with each of the treatment groups receiving a simple sentence of information about COVID-19 vaccines.

The effect of the treatments (using unweighted response data) is shown below.

Survey experiment results: share of respondents willing to be vaccinated

Survey experiment results: share of respondents not willing to be vaccinated

The experts message was not effective in changing views. However, the relative safety message clearly increased the share of respondents willing to be vaccinated and caused a substantial fall in the share of respondents who were unwilling to be vaccinated. Whats more, when we weighted responses, the effects of the social norms message became statistically significant too.

Tackling vaccine hesitancy:

PNG faces an urgent task: it needs to quickly increase COVID-19 vaccination rates. Yet vaccine hesitancy is worryingly high. However, there is hope and opportunity: our research suggests many Papua New Guineans views are not set in stone. The hesitancy appears to be genuine hesitancy, rather than hardened anti-vax attitudes. People are open to having their minds changed, and our research also points to the fact that vaccine hesitancy can be addressed successfully with the right messages and the right messengers. With clear information about vaccine safety, as well the dangers of COVID-19, communicated by local health workers, views can be changed; and ultimately, many lives can be saved.

More:

The drivers of COVID-19 vaccine hesitancy and how to address them: Evidence from Papua New Guinea - World Bank Group

Monitoring of post-vaccination adverse effects has shown increasing numbers of reports of menstrual changes in women who received the coronavirus disease 2019 (COVID-19) vaccine. A new study published on the preprint server medRxiv* reports on the incidence of this adverse effect, concluding that there is no evidence for such an association, while not ruling out the potential for detection of such a link with larger studies.

Study: Effect of COVID-19 Vaccination on Menstrual Periods in A Retrospectively Recruited Cohort. Image Credit: Studio Romantic / Shutterstock.com

The monitoring system called Yellow Card has received many reports from women with alleged changes to their menstrual cycle following vaccination with a COVID-19 vaccine. However, most of these women also reported that their period returned to normal within a single cycle. There is also no observed evidence of disrupted female fertility.

In order to assess the validity of such concerns, the current study included over 1,200 women with a menstrual diary who had also recorded the dates of vaccination. Earlier studies on the human papillomavirus (HPV) vaccine have shown that periods may become heavier or irregular in such individuals, though viral infection itself, even with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), can also cause such changes.

The pathogenesis of this phenomenon may involve immunostimulatory mechanisms that may alter the hormonal cycle. Alternatively, immune cells in the endometrium could be stimulated, thus causing the observed changes by affecting the proliferation and shedding of the tissue.

The cohort tracked in this study is likely to be biased towards those who noted a change in their cycles after vaccination. Therefore, the investigators are currently also tracking another cohort who were already recording their cycles before vaccination. The current study may help, however, to tease out a preliminary hypothesis about a causal link.

Despite the use of different vaccines, there was no obvious correlation between the brand and the presence or type of menstrual alteration in the subsequent cycle. Those who were on hormonal contraceptives were at a greater chance of such changes. Since sex hormones levels are maintained at a low but uniform level in those on oral contraceptives, this could rule out the association between vaccination and levels of sex hormones.

The time of vaccination was not clearly linked to the timing or flow pattern of the next period. The difficulty in finding a clear association partly lies in the sheer variety of changes reported in the period.

There have been many proposed mechanisms for changes in menstruation following COVID-19 vaccination, such as vaccine-induced delay in ovulation or disruption of ovulation. This would lead to a longer cycle than usual.

When considering those who were not on hormonal contraception, vaccination timing apparently appeared to be related to the timing of the next period in those who received the vaccines on pre-ovulatory days, on which less than five people had been vaccinated, and those who were already overdue, the authors found that

This was, however, negated when this association was found to be due to the effect of vaccination on the expected day of periods or the previous day. Taken together, this indicates that these women were already at a high risk of having delayed periods before taking the vaccine. Overall, the timing of the vaccine was not found to be related to the flow of the next period.

After the second dose, the same trends, or lack thereof, were observed. Most women did report the same kind of changes following both doses. This implies the effects of genetic or individual factors are predominant in vaccination-related alterations in period timing or flow.

Association between reports of changes in timing (A) and flow (B) following first and second vaccine dose.

There is an apparent concern about the risk of period delay following vaccination in women who already have polycystic ovarian syndrome (PCOS) or endometriosis. Many women have this concern, stating that with already heavy, painful, and/or difficult periods, they hesitate to take the vaccine for fear of aggravating these symptoms.

In the current study, however, such a trend was not observed in women who had already been diagnosed with a pre-existing condition of the uterus or menstrual abnormality, including those with a history of menorrhagia, abnormal bleeding, uterine fibroids, endometriosis, or PCOS. However, a borderline significance was observed after adjusting for multiple factors.

In particular, women who had heavy or abnormal bleeding or had fibroids were found to have a slightly greater chance of having an earlier period, while a delay in the next period is somewhat more likely in those with a history of PCOS.

The results of the current study do not find any observable associations between the COVID-19 vaccination, the brand of vaccine, and menstrual timing. Delayed periods were reported mostly by women who were already heading for a late period at the date of vaccination.

People on hormonal contraception were at a greater risk for differences in the flow of their next period following vaccination, which rules out a hormonal etiology. The lack of a plausible biological mechanism to explain this mandates follow-up analysis to rule out reporting bias.

That is, since many women use hormonal contraceptives to control their menstrual flow, a heavier flow following vaccination may have led many of them to join the study, as compared to those who are not on such pills but also had heavier flow after taking the vaccine.

The explanation for the high degree of similarity between the changes observed after the first and second doses indicates that individual, including genetic, variation might explain a lot of these changes. Other potential reasons include the eight-week interval between doses, which could mean that whatever biological change followed the first dose, would still exert an effect by the time of the second dose, thus accounting for the similar side effects.

The lack of association between menstrual changes and pre-existing gynecologic disease should reassure women who fear that their condition will worsen after vaccination. People with endometriosis and PCOS did have a slight advancement and postponement of their periods, respectively, which must be followed up for validation. Until then, these findings should not contribute to vaccine hesitancy, especially since it is well-established that SARS-CoV-2 itself affects the menstrual cycle.

The current study does not fully determine the frequency of menstrual changes after COVID-19 vaccination as a result of its retrospective design that lends itself to recall bias. Instead, prospective studies should be done. Alternatively, already collected menstrual data that has been stored for other purposes could be mined to answer this question more accurately.

The authors recommend data from menstrual cycle tracking apps, both because of the volume of data logged over multiple cycles and the detail in which such data is stored. It is also important to note that the study participants were mostly British and that the study did not look at other vaccines like Sinovac or Sputnik V. Most of these other vaccines use a shorter interval between doses, which could lead to different side effects.

In conclusion, this study of 1273 retrospectively recruited participants was unable to detect strong signals to support the idea that COVID-19 vaccination is linked to menstrual changes. However, large, prospectively recruited studies may be able to find associations that we were not powered to detect.

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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Study finds no strong evidence that COVID-19 vaccination is linked to menstrual changes - News-Medical.net

The coronavirus disease 2019 (COVID-19) outbreak caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a sharp rise in deaths and the number of infections worldwide. The pandemic has resulted in the deaths of more than 5.1 million people from more than 254 million infections as of November 18, 2021. Therefore, the development of safe and effective vaccines was considered an important measure to contain the pandemic and restore peoples lives to normal.

As per the global statistics reports from August 2, 2021, there are 326 total vaccine candidates. Out of them, 103 vaccines are in clinical trials, while 19 are now in everyday use. The 19 vaccines include 8 inactivated vaccines, 5 protein subunit vaccines, 2 mRNA vaccines, and 4 non-replicating viral vector vaccines. Furthermore, reports show that 53.7 percent of the world population has received at least one dose of the vaccine, while 41.5 percent are fully vaccinated.

However, the infection rate of COVID-19 is still high due to the emergence of new SARS-CoV-2 variants. Therefore, rapid herd immunity through vaccination is required to prevent the emergence of these new variants that can completely escape the immune surveillance.

The effectiveness and safety of the three mainstream vaccines in the market have been evaluated based on random clinical trials (RCT). The mRNA vaccines were found to be the most effective, followed by viral vector vaccines and inactivated virus vaccines. Although the current safety of the COVID-19 vaccines is high, long-term monitoring needs to be carried out, especially for people with underlying conditions. However, real-world studies vary significantly from the RCT. Mass vaccination in the real world requires considering several heterogeneous populations, vaccine supply, willingness, medical accessibility, etc. Several studies report the effectiveness of vaccines in the real world but the results remain controversial.

A new study published in Infectious Diseases of Poverty aimed to systematically evaluate the effectiveness and safety of the COVID-19 vaccines in the real world as well as establish a reliable evidence-based basis to determine the actual protective effect of the COVID-19 vaccines, especially considering the new waves of infection brought about by the variants.

The study involved searching three databases, PubMed, Embase, and Web of Science, for eligible studies that have been published by July 22, 2021. It included 58 studies, out of which 32 were for vaccine effectiveness and 26 were for a safety study. The study was strictly performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).

Observational studies were included that examined the effectiveness and safety of the COVID-19 vaccines among vaccinated people. Studies with irrelevant subjects, insufficient data, overlapping participants, reviews, editorials, case reports, conference papers, animal experiments, and those that did not clarify the identification of COVID-19 were excluded.

The studies were identified by two investigators who carried out data extraction and also assessed the study quality. A third investigator resolved any disagreements. Finally, meta-analysis was performed with the extracted data to assess the safety and effectiveness of the COVID-19 vaccines.

Flowchart of the study selection

The results of the study reported vaccine effectiveness (VE) separately for the first and second doses. For the first dose, the VE for prevention of infection was 41 percent, for prevention of symptomatic COVID-19 infection was 52 percent, for prevention of hospitalization was 66 percent, for prevention of ICU admission was 45 percent, and for the prevention of COVID-19 related deaths was 53 percent.

While for the second dose, the VE for the prevention of SARS-CoV-2 infection was 85 percent, for prevention of symptomatic COVID-19 was 97 percent, for prevention of hospitalization was 93 percent, for the prevention of ICU admissions was 96 percent, and for the prevention of COVID-19-related death was 95 percent.

Furthermore, the study reported the VE for the various SARS-CoV-2 variants. The VE was 85 percent for prevention against the Alpha variant, 54 percent for the Gamma variant, and 74 percent for the Delta variant. Only one study was available for the Beta variant, where the VE was reported to be 75 percent. The BNT162b2 vaccine was found to have the highest VE for each of the variants.

The study also reported the incidence rate of adverse events for determining the safety of the COVID-19 vaccines. It was found that the incidence rate was 1.5 percent for adverse events, 0.4 percent for serious adverse events, and 0.1 percent for death after vaccination.

Healthcare workers showed a higher incidence rate for adverse events, serious adverse events, as well death after vaccination. Also, the incidence rate of adverse events was found to be higher in the AZD1222 vaccine group, serious adverse events were found to be higher in the Gam-COVID-Vac vaccine group, and death after vaccination was found to be higher in the BNT162b2 vaccine group.

The current study thus indicated that two doses of the vaccine were effective against the different SARS-CoV-2 variants, although their effectiveness was less as compared to the original strain. The adverse events were found to be varied among different COVID-19 vaccine groups. However, serious adverse events were reported that suggest the need to implement a unified global surveillance system to monitor the adverse events of the COVID-19 vaccines around the world. Also, while determining the priority of the vaccines, the socioeconomic characteristics of each country must be considered.

Therefore, it can be concluded that the improvement of vaccine coverage is still the most essential tool that can help to end the pandemic.

The current study had certain limitations. First, the study included limited basic data on specific populations. Second, no subgroup analysis on more population characteristics, such as age was conducted. Third, most of the original studies collected adverse events only up to 7 days post-vaccination. This could have an impact on the safety analysis.

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Real-world effectiveness and safety of COVID-19 vaccines - News-Medical.net