THURSDAY UPDATES: Boone County first in state with beginning and completing coronavirus vaccine with percent of population – ABC17NEWS – ABC17News.com

THURSDAY UPDATES: Boone County first in state with beginning and completing coronavirus vaccine with percent of population – ABC17NEWS – ABC17News.com

COVID-19 deaths, hospitalisations slowing in Brazil, WHO says – Reuters

COVID-19 deaths, hospitalisations slowing in Brazil, WHO says – Reuters

April 30, 2021

A crematorium employee moves a coffin before the cremation of a person who died of the coronavirus disease (COVID-19), in Porto Alegre, Brazil April 29, 2021. REUTERS/Diego Vara

Hospitalisations and deaths from COVID-19 have started declining after four weeks of slowing infections in Brazil, the World Health Organization said on Friday.

"Cases have now declined for four weeks in a row, and hospitalisations and deaths are also declining. This is good news and we hope this trend continues," WHO Director-General Tedros Adhanom Ghebreyesus told a briefing.

Still, he described a severe situation in the country, which this week became the second to pass 400,000 COVID-19 deaths after the United States. read more

"Since the beginning of November, Brazil has experienced an acute crisis, with increasing COVID-19 cases, hospitalisations and deaths, including among younger people. During April, intensive care units have been at almost full capacity across the country," he said.

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COVID-19 deaths, hospitalisations slowing in Brazil, WHO says - Reuters
Wolf Administration Highlights Impact of COVID-19 on Individuals with Substance Use Disorders and Collaborative Projects Through the Opioid Disaster…

Wolf Administration Highlights Impact of COVID-19 on Individuals with Substance Use Disorders and Collaborative Projects Through the Opioid Disaster…

April 30, 2021

Harrisburg, PA - Wolf Administration officials today outlined the impacts of COVID-19 on people living with substance use disorders (SUD) and highlighted projects and collaborations made possible through the opioid disaster declarations creation of the Opioid Command Center.

As we continue to evaluate 2020 overdose trends, we are seeing a significant uptick in fatal overdoses, Acting Secretary of Health Alison Beam said. We know that the COVID-19 pandemic exacerbated the challenges for people with the disease of addiction. Because of the disaster declaration in place, the entire Opioid Command Center, including the Prescription Drug Monitoring Program, is able to offer a variety of support to people in need.

While the 2020 counts are expected to increase further since finalized death records for overdose deaths are often delayed into the following year, there have been 4,880 drug overdose deaths reported thus far. This preliminary data, as of March 2021, indicates there were at least 422 more deaths in 2020 than in 2019. Since the overdose epidemic began, the most overdose deaths in Pennsylvania during a single year was 5,396 in 2017.

To understand potential reasons for the increase in overdose deaths and to identify opportunities to assist, the Opioid Command Center is holding meetings with counties, including Pike, Cambria, Allegheny, and Lebanon, that experienced the most significant increases in overdoses during 2020. Meeting topics include fatal overdoses, emergency department visits for overdose, and EMS naloxone administrations and strategies to reduce overdoses at a local level.

The state and local partnerships brought together by the command center have never been more important, said DDAP Secretary Jen Smith. As we navigate the coming months and impacts of COVID-19 on individuals with a substance use disorder and those in recovery, the Wolf Administration is committed to continuing the fight to ensure all Pennsylvanians have access to necessary, life-saving resources.

Through the collaborative effort of the command center, the Wolf Administration has been able to break down decade-long silos across agencies and work together to make a positive impact on Pennsylvanians struggling with the disease of addiction.

Prescription Drug Monitoring Program

Since the Prescription Drug Monitoring Program (PDMP) launched in 2016, there has been a 58 percent reduction in the number of individuals receiving a high dosage of opioid medication, a 54 percent reduction in the number of individuals receiving a dangerous drug combination of opioids and benzodiazepines, and a 38 percent reduction in opioid prescribing overall. In addition, there has been a 30 percent increase in the prescribing of buprenorphine, which is used to treat opioid use disorder as part of Medication-Assisted Treatment (MAT).

Naloxone for First Responders Program

Since the launch of the Naloxone for First Responders Program (NFRP) in November 2017, Centralized Coordinating Entities (CCEs) have distributed 92,980 kits (2 doses each) of Narcan to first responders across the commonwealth, including 29,578 kits distributed in 2020. These efforts have resulted in more than 17,970 overdose reversals reported to date by CCEs, including 5,282 reversals reported in 2020.

In March of 2021, the command center announced the availability of the Statewide Naloxone Allocation Request Portal which allows eligible organizations serving high-risk populations the ability to request additional naloxone nasal spray.

Police Diversion to Treatment

As of March 2021, the Police Diversion to Treatment project continues to support seven local Single County Authorities in expanding or creating collaboratives between law enforcement, treatment professionals, and recovery support providers to establish diversion programs aimed at offering treatment-based alternatives to arresting, booking, and incarceration for minor criminal offenses.

To date, 322 law enforcement officers have received training on a variety of topics related to police diversion, and 122 individuals were referred to and admitted into SUD treatment versus incarceration.

Medication-Assisted Treatment in State Corrections Facilities

In January 2018, after Governor Wolf signed the first Opioid Disaster Declaration, the Wolf Administration directed that MAT be provided within the Department of Corrections (DOC) prison system. During 2018, the Vivitrol program expanded to all 25 state prisons and in April 2019, the DOC began a pilot project program offering Sublocade injections at State Correctional Institution Muncy. In February 2020, the Wolf Administration announced more than $1.2 million in grants to nine county jails to support the county jail-based MAT program.

Supporting Pennsylvania Veterans

The Department of Military and Veteran Affairs (DMVA) continues to support a variety of existing and new programs tailored to the unique needs of veterans with opioid and stimulant use disorders. These programs provide a combination of evidence-based co-occurring treatment including treatment courts, recovery support, and robust case management services.

Since September 30, 2020, across 11 organizations, and despite barriers related to COVID-19, a total of 432 Veterans have been served, and 53 staff have received specialized training related to these projects. Of the over 400 Veterans served, 98 percent of participants report a reduction in substance use, and 88 percent report an overall improvement in quality of life.

Our collaboration with DDAP to provide grants to veteran advocates is making a huge difference by educating and helping veterans overcome their substance use disorder, said Brig. Gen. (ret.) Maureen Weigl, Department of Military and Veterans Affairs deputy adjutant general for Veterans Affairs. However, now is not the time to take our foot off the pedal. We need to continue working together with a focus on raising awareness and reducing the number of veterans and members of the general public with a substance use disorder to zero.

The Opioid Command Center, established in January 2018 when Gov. Wolf signed the first opioid disaster declaration, continues to meet weekly to discuss the opioid crisis and overdose deaths across the commonwealth. The command center is staffed by personnel from 17 state agencies and the Office of the Attorney General, spearheaded by the Department of Health (DOH) and Department of Drug and Alcohol Programs (DDAP).

Last year the Opioid Command Center released its strategic plan to address substance use from a comprehensive approach. Work to address the opioid crisis focuses on four areas: prevention, rescue, treatment, and recovery. Efforts over the past several years, working with state agencies, local, regional, and federal officials, have resulted in significant action to address the opioid crisis.

To learn more about those efforts, visit www.pa.gov/opioids.

MEDIA CONTACTS: Barry Ciccocioppo, Health, ra-dhpressoffice@pa.gov Ali Gantz, DDAP, ra-dapressoffice@pa.gov Joan Nissley, DMVA, jnissley@pa.gov

# # #


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Norway to speed up first COVID-19 jabs by delaying second dose – Reuters

Norway to speed up first COVID-19 jabs by delaying second dose – Reuters

April 30, 2021

Norway said on Friday it will extend the time between first and second doses of COVID-19 vaccines to 12 from six weeks for most adults under the age of 65 in order to reach its first vaccination target sooner than planned.

The decision could allow all adults in Norway to receive a first jab by July 25 the Institute of Public Health (FHI) and health ministry said in a statement.

The extension relates to both the Pfizer-BioNTech (PFE.N), (22UAy.DE) and Moderna (MRNA.O) vaccines, which are the only ones currently used in Norway.

Norway's FHI had previously estimated that all adults would be offered their first dose by Aug 29.

"Increasing the interval will allow many more to be vaccinated earlier. This will prevent serious illness and death, and reduce the overall level of infection in society," Health Minister Bent Hoeie said.

Studies have shown that the difference in effect from extending the interval at which the two doses are given is minimal, the ministry added.

If Norway decides to also use COVID-19 vaccines made by AstraZeneca (AZN.L) and Johnson & Johnson (JNJ.N), this could speed up the process further.

Norwegian authorities last month suspended the rollout of the AstraZeneca vaccine after a small number of younger, inoculated people were hospitalised for a combination of blood clots, bleeding and a low count of platelets.

Some later died. read more

A decision on whether to use Johnson & Johnson's vaccine is on hold over similar concerns and a government-appointed commission is due to advise on the potential use of both vaccines by May 10.

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Norway to speed up first COVID-19 jabs by delaying second dose - Reuters
Conn. Has Lowest Increase in COVID-19 Cases in 6 Months: Governor – NBC Connecticut

Conn. Has Lowest Increase in COVID-19 Cases in 6 Months: Governor – NBC Connecticut

April 30, 2021

The governor said Connecticut has the lowest increase in COVID-19 cases that's been seen in six months. He said this may be a result of more residents getting vaccinated against the virus.

The state's positivity rate is at 1.34% and 486 people tested positive out of 36,200 tests performed since Wednesday.

Daily coronavirus cases have seen a decrease of approximately 50% over the past couple of weeks, according to Chief Operating Officer Josh Geballe.

Full coverage of the COVID-19 outbreak and how it impacts you

Net hospitalizations are down by four at 403. That's the lowest number seen in more than a month.

Four more virus-related deaths have been reported. The death toll is now at 8,084, state officials said.

The state's positivity rate was 2.29% on Wednesday.

Starting Saturday, some COVID-19 restrictions across Connecticut will be lifted. This includes moving the business curfew back to 12 a.m. and lifting outdoor restrictions. There will be no table size limit and alcohol without food will be allowed.

The CDC doesn't want you going out with friends right after full vaccination, but is encouraging waiting two weeks for coronavirus antibodies to kick in. NBC News Medical Correspondent Dr. John Torres weighs in on those guidelines and also discusses the COVID-19 crisis in India, where hundreds of thousands of cases are being reported each day, and oxygen and ventilators are in high demand.

Governor Ned Lamont said all colleges in the state have completed first dose clinics.

There are over 100 vaccination clinics offering walk-up appointments. For a list of these clinics, click here.

Nearly 1.9 million first doses of the COVID-19 vaccine have been administered across the state. A total of 1.32 million people are fully vaccinated, according to state officials.

The Johnson & Johnson vaccine is once again being administered at clinics across Connecticut. Approximately 5,000 doses have been given out since the pause was lifted last week.

Large event and large employer vaccine clinics are available, according to the governor.


Follow this link: Conn. Has Lowest Increase in COVID-19 Cases in 6 Months: Governor - NBC Connecticut
COVID-19 variants believed to be cause of virus outbreak at local middle school – KUTV 2News
Amish In Ohio Aren’t Getting Vaccinated Despite High COVID Infections, Deaths : Shots – Health News – NPR

Amish In Ohio Aren’t Getting Vaccinated Despite High COVID Infections, Deaths : Shots – Health News – NPR

April 30, 2021

Holmes County, Ohio, General Health District staff members (from left) Michael Derr, Jennifer Talkington and Abbie Benton prepare materials for a COVID-19 vaccine clinic this month inside St. Peter's Catholic Church in Millersburg. Anna Huntsman/WCPN hide caption

Holmes County, Ohio, General Health District staff members (from left) Michael Derr, Jennifer Talkington and Abbie Benton prepare materials for a COVID-19 vaccine clinic this month inside St. Peter's Catholic Church in Millersburg.

The Amish communities of northeast Ohio engage in textbook communal living. Families eat, work and go to church together, and through the pandemic, mask-wearing and social distancing have been spotty. As a result, these communities have experienced some of the state's highest rates of infection and deaths.

Nevertheless, health officials are struggling to get residents vaccinated. Holmes County, where half of the population is Amish, has the lowest vaccination rate in Ohio, with just 10% of its roughly 44,000 residents fully vaccinated.

Less than 1% of Amish have received any doses of vaccine, according to Michael Derr, the county's health commissioner.

In an effort to increase that number, health officials are holding vaccination clinics in rural areas. They've also reached out to bishops and community leaders to spread the word about the safety of the vaccines. Still, few Amish residents are showing up to the health department's clinics.

Marcus Yoder, who lives in Holmes County, was born Amish and is now Mennonite and still has close ties to the Amish community. He says the few Amish who are getting vaccinated are doing so privately through doctors' offices and small rural clinics and they are keeping it to themselves.

"There were Amish people getting the vaccination the same day I was ... and we all kind of looked at each other and smiled underneath our masks and assumed that we wouldn't say that we saw them," Yoder says.

He says many Amish don't want to get vaccinated because they already had COVID-19 and believe the area has reached herd immunity.

Another main driving force is "the misinformation about COVID itself that it's not more serious than the flu," says Yoder, who runs a history center about the Amish and Mennonite. "They're saying, 'Well, it didn't affect me that much. Look at all these old people who survived.' "

A man zips by on a walking and biking trail in Holmes County, home to one of the largest settlements of Amish in the United States. Anna Huntsman/WCPN hide caption

A man zips by on a walking and biking trail in Holmes County, home to one of the largest settlements of Amish in the United States.

Some Amish residents are skeptical of the safety and effectiveness of the vaccines, and anti-vaccination conspiracy theories also spread throughout the community. There is also a lack of awareness about the more contagious variants spreading across the country, Yoder says.

"I think we're going to see some more cases in our community, unfortunately, because of this," he says. "There simply is a lot of COVID news fatigue. They simply do not want to hear about it, and that's really unfortunate."

While some sort of herd immunity could explain why Holmes currently has a low incidence of new cases, Derr at the health department is concerned that those who previously had the virus may not be protected.

"As a region, we definitely surged over the winter, and we know that that happened about 90 days ago," Derr says. "We're primed and ready for another surge because we're not vaccinating enough."

Health officials in Indiana and Pennsylvania which, combined with Ohio account for the largest Amish communities also are ramping up outreach in heavily Amish areas. Local health departments in Pennsylvania's Lancaster County, home to the largest Amish population in the country, are connecting with Amish bishops to try to spread the word about the vaccines.

The widespread reluctance to get vaccinated in Amish communities is not surprising to West Virginia University sociologist Rachel Stein, who studies Amish populations across the country.

"We as non-Amish are more on board with preventative medicine," Stein says. "They certainly don't have that mindset that we need to do things to stop this from happening."

Instead, she says there's an acceptance that people will get sick and get better or not. While childhood vaccinations have increased in Ohio's Amish communities in recent years, adults are still more hesitant, she adds.

"There's oftentimes frequent breakouts of whooping cough in a settlement, and it's just like ... 'This is happening now. We're in whooping cough season, and so it's time to deal with this sort of thing,' " she says.

In 2014, a measles outbreak spread rapidly through Ohio's largely unvaccinated Amish communities. Even after this experience, many Amish residents still choose not to vaccinate their children against other diseases.

The low vaccination interest in Holmes County tracks national trends showing residents of rural areas are less likely to consider getting vaccinated.

A recent poll from the Kaiser Family Foundation found 3 in 10 rural residents will "definitely not" get the COVID-19 vaccine unless it is mandated.

Yoder says he thinks the best path forward is to encourage Amish residents who were vaccinated to talk openly about their positive experience getting the shots.

"I think that hammering people for not doing it will not get us anywhere," Yoder says. "Some of the local business leaders have done very, very well at saying, 'Look, let's get the vaccination so we don't have to wear masks in the future, so we don't have to worry about social distancing as much in the future.' And they've used that tact and that has been a healthy way to approach it."

Derr, the Holmes County health commissioner, is trying to get business owners who employ Amish workers to encourage their staff to get the shot. Officials hope eventually to hold vaccine clinics at these businesses and take the shots to them, but not every business owner is on board with that yet, he says.

"People are going to listen to their friends and their family, people who they interact with more, and it's going to be that telephone effect," Derr says. "The more and more people we tell about it and the better experiences they have, word will get around."

Derr expects more Amish will get vaccinated in the fall after the shots have been around for some time but worries the community could see a spike in cases long before then.

This story comes from NPR's partnership with Cleveland's ideastream and Kaiser Health News.


Original post: Amish In Ohio Aren't Getting Vaccinated Despite High COVID Infections, Deaths : Shots - Health News - NPR
Tracking COVID-19 in Alaska: 161 cases and no deaths reported Thursday – Anchorage Daily News

Tracking COVID-19 in Alaska: 161 cases and no deaths reported Thursday – Anchorage Daily News

April 30, 2021

We're making this important information available without a subscription as a public service. But we depend on reader support to do this work. Please consider supporting independent journalism in Alaska, at just $1.99 for the first month of your subscription.

A slight increase in the daily case rate since March has somewhat plateaued. However, most regions in the state are still in the highest alert category based on their current per capita rate of infection, and health officials continue to encourage Alaskans to wear face coverings in public, avoid large gatherings, wash their hands frequently and get vaccinated against COVID-19 to prevent further spread.

By Thursday, there were 54 people with confirmed or suspected cases of COVID-19 in hospitals throughout the state, far below a peak in late 2020 but slightly up compared to recent days.

By Thursday, 308,040 people about half of all Alaskans eligible for a shot had received at least their first dose. At least 261,074 people about 44% of Alaskans 16 and older were considered fully vaccinated, according to the states vaccine monitoring dashboard.

Alaska in January led the country in per capita vaccinations, but has now fallen to 22nd place among all 50 states and Washington, D.C., according to data from the U.S. Centers for Disease Control and Prevention.

You can visit covidvax.alaska.gov or call 907-646-3322 to sign up for a vaccine appointment; new appointments are added regularly. The phone line is staffed 9 a.m. to 6:30 p.m. on weekdays and 9 a.m. to 4:30 p.m. on weekends.

Of the 158 cases reported among Alaska residents on Thursday, there were 49 in Anchorage plus six in Eagle River; 34 in Fairbanks; 20 in Wasilla; 16 in North Pole; nine in Palmer; four in Soldotna; two in Kodiak; two in Ketchikan; one in Kenai; one in Seward; one in Sterling; one in Delta Junction; one in Houston; one in Utqiagvik; one in Juneau; one in Unalaska; and one in Chevak.

Among communities smaller than 1,000 people that arent named to protect residents privacy, there were two in the Fairbanks North Star Borough; one in the Prince of Wales and Hyder Census Area; one in the Aleutians East Borough; one in the Bethel Census Area; and two in the Kusilvak Census Area.

There were also three new cases among nonresidents: one in Wasilla, one in Juneau and one in an unidentified region of the state.

While people might get tested more than once, each case reported by the state health department represents only one person.

The states data doesnt specify whether people testing positive for COVID-19 have symptoms. More than half of the nations infections are transmitted from asymptomatic people, according to CDC estimates.

Of all the tests conducted over the past week, 2.8% came back positive.


See the article here: Tracking COVID-19 in Alaska: 161 cases and no deaths reported Thursday - Anchorage Daily News
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review – FDA.gov

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review – FDA.gov

April 30, 2021

For Immediate Release: April 23, 2021

Espaol

Following a thorough safety review, including two meetings of the CDCs Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

The two agencies have determined the following:

CDCs independent Advisory Committee on Immunization Practices met today to discuss the latest data on TTS, hearing from the vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (VaST) Subgroup, as well as a risk benefit analysis. ACIP is committed to be vigilant and responsive to additional information that could impact the risk benefit analysis of any of these vaccines. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed.

Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to workidentifying even these small number of cases. Weve lifted the pause based on the FDA and CDCs review of all available data and in consultation with medical experts and based on recommendations from the CDCs Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider, said Janet Woodcock, M.D., Acting FDA Commissioner.

Above all else, health and safety are at the forefront of our decisions, said CDC Director Dr. Rochelle P. Walensky. Our vaccine safety systems are working. We identified exceptionally rare events out of millions of doses of the Janssen COVID-19 administered and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.

Assessment of Available Data

Medical and scientific teams at the FDA and CDC reviewed several sources of information and data related to the Janssen COVID-19 Vaccine to reach todays decision.

Specifically, the agencies assessed reports submitted to the Vaccine Adverse Event Reporting System (VAERS), reviewed the medical literature and considered the information from global regulatory partners about thrombosis with thrombocytopenia that have been reported following use of a similar, yet not identical, COVID-19 vaccine using a virus from the adenovirus family that has been modified to contain the gene for making a protein from SARS-CoV-2.

Update on Adverse Events

On April 13, the FDA and CDC announced that, out of more than 6.8 million doses administered, six reports of a rare and severe type of blood clot combined with low blood platelet levels occurring in people after receiving the Janssen COVID-19 Vaccine had been reported to VAERS. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

Today, the agencies can confirm that a total of 15 cases of TTS have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination.

Monitoring for Safety Will Continue

The surveillance systems that are in place to monitor the safety of COVID-19 vaccines authorized for emergency use are working, as demonstrated by both agencies quick work to identify and investigate these rare, but serious adverse events. The FDA and CDC will continue with these efforts to closely monitor the safety of these vaccines.

Reports of adverse events following vaccination can be made to the Vaccine Adverse Event Reporting System.

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Read more from the original source: FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review - FDA.gov
Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, officials say – CNN

Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, officials say – CNN

April 30, 2021

These vaccines have been in use since mid-December under emergency use authorizations, known as EUAs. During the pandemic, real-world data have shown the vaccines are effective against the coronavirus that causes Covid-19.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Jim Sciutto on Wednesday he hopes Covid-19 vaccines will receive full FDA approval "very soon," and that the FDA will work "as expeditiously as possible" on approval applications for coronavirus vaccines as they come in.

Progressing from authorized to approved would allow manufacturers to market and directly distribute their vaccines. It could also have an impact on vaccine mandates -- and perhaps sway skeptics hesitant to get the vaccines now.

Currently, the three Covid-19 vaccines distributed in the United States -- made by Pfizer/BioNTech, Moderna and Johnson & Johnson -- are authorized, but not approved.

CNN has contacted Pfizer/BioNTech, Moderna and Johnson & Johnson -- the most recent Covid-19 vaccine to be authorized -- about their plans to apply for full approval of their vaccines. None provided a timeline.

The FDA also requires vaccine manufacturers to submit data to support their manufacturing processes, facilities, product characterization and demonstration that the vaccine can be produced reliably and consistently.

Once all of that is complete -- both the clinical trials and manufacturing details -- companies can submit a Biologics License Application or BLA to the FDA.

"FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States."

After all, as spread of the virus is reduced, the nation may no longer be under an emergency situation and the vaccines will need a different type of green light under the FDA.

The agency is "the gold standard of a safety and regulatory organization throughout the world," said Fauci, chief medical adviser to President Biden. "I hope they do it quickly."

If history is any indication, skepticism -- if not outright mistrust -- about an unapproved vaccine is nothing new.


Read the original: Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, officials say - CNN
What Covid-19 Vaccine Skeptics Have in Common – The New York Times

What Covid-19 Vaccine Skeptics Have in Common – The New York Times

April 30, 2021

For years, scientists and doctors have treated vaccine skepticism as a knowledge problem. If patients were hesitant to get vaccinated, the thinking went, they simply needed more information.

But as public health officials now work to convince Americans to get Covid-19 vaccines as quickly as possible, new social science research suggests that a set of deeply held beliefs is at the heart of many peoples resistance, complicating efforts to bring the coronavirus pandemic under control.

The instinct from the medical community was, If only we could educate them, said Dr. Saad Omer, director of the Yale Institute for Global Health, who studies vaccine skepticism. It was patronizing and, as it turns out, not true.

About a third of American adults are still resisting vaccines. Polling shows that Republicans make up a substantial part of that group. Given how deeply the country is divided by politics, it is perhaps not surprising that they have dug in, particularly with a Democrat in the White House. But political polarization is only part of the story.

In recent years, epidemiologists have teamed up with social psychologists to look more deeply into the why behind vaccine hesitancy. They wanted to find out whether there was anything that vaccine skeptics had in common, in order to better understand how to persuade them.

They borrowed a concept from social psychology the idea that a small set of moral intuitions forms the foundations upon which complex moral worldviews are constructed and applied it to their study of vaccine skepticism.

What they discovered was a clear set of psychological traits offering a new lens through which to understand skepticism and potentially new tools for public health officials scrambling to try to persuade people to get vaccinated.

Dr. Omer and a team of scientists found that skeptics were much more likely than nonskeptics to have a highly developed sensitivity for liberty the rights of individuals and to have less deference to those in positions of power.

Skeptics were also twice as likely to care a lot about the purity of their bodies and their minds. They disapprove of things they consider disgusting, and the mind-set defies neat categorization: It could be religious halal or kosher or entirely secular, like people who care deeply about toxins in foods or in the environment.

Scientists have found similar patterns among skeptics in Australia and Israel, and in a broad sample of vaccine-hesitant people in 24 countries in 2018.

At the root are these moral intuitions these gut feelings and they are very strong, said Jeff Huntsinger, a social psychologist at Loyola University Chicago who studies emotion and decision-making and collaborated with Dr. Omers team. Its very hard to override them with facts and information. You cant reason with them in that way.

These qualities tend to predominate among conservatives but they are present among liberals too. They are also present among people with no politics at all.

Kasheem Delesbore, a warehouse worker in northeastern Pennsylvania, is neither conservative nor liberal. He does not consider himself political and has never voted. But he is skeptical of the vaccines along with many institutions of American power.

Mr. Delesbore, 26, has seen information online that a vaccine might harm his body. He is not sure what to make of it. But his faith in God gives him confidence: Whatever happens is Gods will. There is little he can do to influence it. (Manufacturers of the three vaccines approved for emergency use by the Food and Drug Administration say they are safe.)

The vaccines have also raised a fundamental question of power. There are many things in Mr. Delesbores life that he does not control. Not the schedule at the warehouse where he works. Or the way he is treated by the customers at his other job, a Burger King. The decision about whether to get vaccinated, he believes, should be one of them.

April 30, 2021, 12:50 p.m. ET

I have that choice to decide whether I put something in my own body, Mr. Delesbore said. Anybody should.

Mr. Delesbore has had many jobs, most of them through temporary agencies at a park concession stand, at an auto parts warehouse, at a FedEx warehouse, and at a frozen food warehouse. He is sometimes overcome by a sense that he will never be able to get beyond the stress of living paycheck to paycheck. He remembers once breaking down to his parents.

I told them, what am I supposed to do? he said. How are we supposed to make a living? Buy a house and start a family? How?

Like many people interviewed for this article, Mr. Delesbore spends a lot of time online. He is hungry to make sense of the world, but it often seems rigged and it is hard to trust things. He is especially suspicious of how fast the vaccines were developed. He used to work at a factory of the drug company Sanofi, so he knows a bit about the process. He believes there is a lot that Americans are not being told. Vaccines are just one small piece of the picture.

Conspiratorial thinking is another predictor of vaccine hesitancy, according to the 2018 study. Conspiracy theories can be comforting, a way to get ones bearings during rapid change in the culture or the economy, by providing narratives that bring order. They are finding fertile ground because of a decades-long decline in trust in government, and a sharp rise in inequality that has led to a sense, among many Americans, that the government is no longer working on their behalf.

Theres a whole world of secrets and stuff that we dont see in our everyday lives, Mr. Delesbore said. Its politics, its entertainment, its history. Everything is a facade.

The moral preference for liberty and individual rights that the social psychologists found to be common among skeptics has been strengthened by the countrys deepening political polarization. Branden Mirro, a Republican in Nazareth, Pa., has been skeptical of nearly everything concerning the pandemic. He believes that mask requirements impinge on his rights and does not plan to get vaccinated. In fact, he sees the very timing of the virus as suspicious.

This whole thing was a sham, he said. They planned it to cause mass panic and get Trump out of office.

Mr. Mirro, who is 30, grew up in a large Italian-American family in northeastern Pennsylvania. His father owned a landscaping business and later invested in real estate. His mother battled a yearslong addiction to methamphetamine. He said she died this year with fentanyl in her bloodstream.

From an early age, politics was an outlet that brought meaning and importance. He has volunteered for presidential campaigns, watched inaugurations, and gone to rallies for Donald J. Trump. He even went to Washington on Jan. 6, the day of the riot at the U.S. Capitol.

He said that he went because he wanted to stand up for his freedoms, and that he did not go inside the Capitol or support the violence that happened. He also said he believed that Democrats have been hypocritical in how they responded to that event, compared with the unrest in cities last summer following the murder of George Floyd.

Democrats, he said, used to fight for things that were good. He has a picture of John F. Kennedy up on his wall. But they have become dangerous, he said, canceling people and creating racial divisions by what he sees as a relentless emphasis on racial differences.

This isnt the country I grew up in, he said. I have a love for this country, but its turning into something ugly.

Vaccine skeptics are sometimes just as wary of the medical establishment as they are about the government.

Brittany Richey, a tutor in Las Vegas, does not want to get one of the vaccines because she does not trust the drug companies that produced them. She pointed to studies that she said described pharmaceutical companies paying doctors to suppress unfavorable trial results. She keeps a folder on her computer of them.

Ms. Richey said that when she was 19, she was put into a line of girls waiting for the HPV vaccine, which protects against cervical and other cancers, after a routine doctors appointment. She said she did not fully understand what the shot was and why she was being asked to get it.

Thats not informed consent, thats coercion, said Ms. Richey, who is now 33.

Ms. Richey is also worried about the ingredients of the vaccines. She is trying to get pregnant, and she knows that pregnant women were excluded from vaccine trials. She does not want to risk it.

A portion of those who are hesitant will eventually get vaccinated. According to Drew Linzer, the director of the polling firm Civiqs, fewer people are unsure about the vaccines now than in the fall, but the percentage of hard noes has remained fairly constant. As of last week, about 7 percent say they are unsure, he said, and about 24 percent say they will never take it.

Mary Beth Sefton, a retired nurse in Wyoming, Mich., who is a moderate conservative, is not opposed to all vaccines: She usually gets a flu shot. But she worries that the Covid-19 vaccines were developed so quickly that there might be side effects that have not surfaced yet. So she has not gotten a vaccine yet despite being eligible for several months.

Ms. Sefton, who is 73 and describes herself as a person who doesnt like being told what to do, says the politicization of the virus has made it hard to find information she trusts.

The polarization makes it much harder to figure out what is real, she said.

She thinks she might eventually get a vaccine. Her husband is bedridden and she is his primary caregiver. And she would be cut off from some in her family if she remains unvaccinated. But she is nervous.

I still feel exceedingly cautious, she said. It is a basic gut feeling.


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What Covid-19 Vaccine Skeptics Have in Common - The New York Times