Category: Covid-19 Vaccine

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Bill to ban government entities from requiring COVID-19 vaccines advances – WATE 6 On Your Side

April 1, 2021

NASHVILLE, Tenn. (WKRN) Should you be required to get a COVID-19 vaccination? Thats the question lawmakers are debating.

Its a conversation happening around the world and Tennessee is now advancing a bill that would restrict governmental entities from requiring a coronavirus shot.

Were not here to argue whether or not vaccines are good or bad were not here to argue the science behind COVID, were simply saying we are against a government mandate to a medical treatment especially without a religious exemption, said Gary Humble, organizer of the rally.

Currently, there is not a requirement for COVID-19 shots to be taken in Tennessee.

The approved U.S. vaccines have shown the doses are effective against severe illness and death.

The amended bill passed the Senate Health and Welfare committee by a party line vote 8-1.

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Bill to ban government entities from requiring COVID-19 vaccines advances - WATE 6 On Your Side

SpartanNash hosting two COVID-19 vaccine clinics – MLive.com

April 1, 2021

HUDSONVILLE, MI SpartanNash is hosting two vaccine clinics at its former Family Fare grocery store at 5221 Cherry Ave. in Hudsonville.

The clinics are scheduled from 9 a.m. to 7 p.m. on Friday, April 2 and Tuesday, April 6, the company said in a news release.

Appointments can be scheduled online and are available three days prior to each clinic. Both clinics are open to anyone 16 and older. To receive the vaccine, customers must have an appointment and complete a health screening.

Receiving a COVID-19 vaccination is the best way to help stop this virus and pandemic, Lori Raya, executive vice president and chief merchandising and marketing officer at SpartanNash, said in a statement. Getting vaccinated adds one more layer of protection for you, your coworkers, your family and your loved ones. SpartanNash and our family of retail pharmacies are here for our local communities, and we are committed to providing them with a safe, clean environment to receive this important vaccine.

Our pharmacists have and will continue to play an important role in the fight against the coronavirus, and we look forward to administering more than 2,200 total vaccines in the next week and beyond.

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SpartanNash hosting two COVID-19 vaccine clinics - MLive.com

Could COVID-19 vaccine passports be the ticket to pre-pandemic activities? – FOX 31 Denver

April 1, 2021

DENVER Starting Friday, anyone over 16 in Colorado can get a COVID-19 vaccine.

For many, that vaccination will provide a path to normalcy and a pre-pandemic way of life.

However, many are wondering whether businesses will be able to require proof of vaccination.

Everyone wants to feel safe and this is the easiest way to prove that, said Steve Herr, the General Manager of the Staples store in Glendale.

Herrs store has been busy laminating COVID-19 vaccination cards. Staples stores nationwide are offering the service free of charge right now.

Today it was probably close to 45 of them alone, he said.

Airlines, stadiums, and cruise ships could soon start requiring proof of vaccination. Even Red Rocks has explored the idea.

I think the industry as a whole is looking at how this might play out, explained Brian Kitts, with Denver Arts and Venues. Bluntly though, I dont think theres enough time or technology to get this going for this season.

However, implementing such a system is easier said than done.

Christian Hadigree is the Dean of the School of hospitality at Metropolitan State University in Denver.

She believes airlines and many foreign countries will likely start requiring proof of vaccination, especially for international travel, but says implementing such a system is easier said than done, especially at restaurants, stadiums, and in the workplace.

In the United States I cant see Kansas saying you have to have a passport to come to our state. I also think were going to see lawsuits. When are you infringing on rights to privacy? Do I have a right to be out in public engaging in these services? We are the freest country on the planet and the more you try to limit that, the more challenges youll have from the population as a whole,Hadigree said.

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Could COVID-19 vaccine passports be the ticket to pre-pandemic activities? - FOX 31 Denver

30% of Wisconsin residents have received COVID-19 vaccine – WEAU

April 1, 2021

MADISON, Wis. (WBAY, WEAU) - 3 out of 10 people in the state of Wisconsin have received a COVID-19 vaccine.

The latest data from the Wisconsin Department of Health Services show 1,765,007 Wisconsin residents have received at least one dose, which is 38,488 more than reported the day before.

These include 1,040,039 people who are fully vaccinated, which is 26,426 more people since Tuesdays report. These can include vaccinations over the past couple days as vaccinators reports are still coming in to the DHS.

In all, vaccinators in the state have administered 2,813,475 shots of the Pfizer, Moderna or Johnson & Johnson vaccines.

By our calculations, the state is averaging 53,572 shots a day over the past 7 days (the record 7-day average set last week is 55,790 shots per day).

Percentages that received and completed their vaccinations so far, by age group:

Wednesday, the Wisconsin Supreme Court ruled the Evers administration exceeded its authorities with continual health emergencies during the COVID-19 pandemic, effectively striking down the statewide mask mandate (see related story). However, masks can still be required in municipalities that issued their own mask orders and in private businesses, including stores and restaurants (see related story).

Health officials says we cant led our guard down yet against the coronavirus. Wearing masks -- which have to be over the nose -- maintain 6 feet from anyone who isnt from your household, even visiting friends and relatives; and wash your hands more frequently or use sanitizer.

Tuesday, Gov. Evers announced everyone age 16 and older will be eligible for the vaccine starting next week on April 5, regardless of health condition or where they work. Making more teens and young adults eligible for the vaccine could help against virus outbreaks weve seen in our area and nationwide blamed on people of high school and college age getting together without wearing a face mask over their nose or social distancing. While these age groups are less likely to suffer serious effects of the coronavirus developing into COVID-19, they can be asymptomatic and spread the disease to more vulnerable people.

WEDNESDAYS VACCINATION TOTALS

WISCONSIN ALLOCATED: 3,002,745 ADMINISTERED: 2,813,475

PFIZER: 1,484,696 MODERNA: 1,269,862 JOHNSON & JOHNSON: 58,791

FIRST DOSE: 1,765,007 (30.3%) FULLY VACCINATED: 1,040,039 (17.9%)

EAU CLAIRE CO. FIRST DOSE: 34,169 (32.7%) FULLY VACCINATED: 23,218 (22.2%)

CHIPPEWA CO. FIRST DOSE: 19,869 (30.7%) FULLY VACCINATED: 12,965 (20.1%)

LA CROSSE CO. FIRST DOSE: 41,580 (35.2%) FULLY VACCINATED: 25,313 (21.4%)

DUNN CO. FIRST DOSE: 11,016 (24.3%) FULLY VACCINATED: 6,947 (15.3%)

CASES AND DEATHS

The Department of Health Services (DHS) reported 10 more deaths from COVID-19, the second straight day in double digits. The 7-day average held steady at 4 because eight days ago there were also 10 deaths which are no longer counted in the average. The death rate has been 1.15% of coronavirus cases for over three weeks.

Wisconsin reported an astounding 17,539 coronavirus test results, the first time weve seen testing over 10,000 since February 25, and the most results in a single day since November 21. We dont know the reason for the state having this many test results at this time. These only include people who are being tested for the first time or tested positive for the first time.

There were 563 positive tests in that batch, which is a mere 3.21% of the results.

Wisconsins average for new cases fell to 471, after rising to 501 yesterday, because last week Tuesdays 776 new cases are no longer counted in that 7-day average.

New cases were found in 57 of Wisconsins 72 counties. Another two counties (Forest and Kewaunee) had their case numbers revised.

New deaths were reported in Dodge, Kenosha, Lincoln, Milwaukee, Outagamie, Washington and Waukesha counties. The state revised death totals in Racine County.

The positivity rates 7-day average looking at all tests, including people whove been tested multiple times, held at 2.8% for a second day. Its been rising since March 11 after it reached a low of 2.0%.

Since February 5, 2020, the state reports:

County-by-county case and death totals will be updated later in this article.

HOSPITAL READINESS

Within the past 24 hours, the DHS says 67 people were admitted for COVID-19, two more than Tuesday. The 7-day average is 49 new COVID-19 patients per day. The state says 4.8% of all coronavirus cases have resulted in hospitalization.

According to the Wisconsin Hospital Association (WHA), there are 233 currently hospitalized COVID-19 patients in 136 hospitals across the state, a decrease of 17 from Tuesday. There are 59 in ICU, which is seven fewer in the ICU than the day before. Changes in daily hospitalizations take discharges and deaths into account.

WEDNESDAYS COUNTY CASE AND DEATH UPDATES (counties with new cases or deaths are indicated in bold) *

Wisconsin

Adams 1,626 cases (+3) (10 deaths)

Ashland 1,200 cases (+2) (16 deaths)

Barron 5,524 cases (+7) (76 deaths)

Bayfield - 1,079 cases (19 deaths)

Brown 30,695 cases (+31) (232 deaths)

Buffalo 1,327 cases (+1) (7 deaths)

Burnett 1,232 cases (+2) (22 deaths)

Calumet 5,601 (+5) (46 deaths)

Chippewa 7,183 cases (+6) (93 deaths)

Clark 3,168 cases (+1) (58 deaths)

Columbia 5,176 cases (+4) (56 deaths)

Crawford 1,677 cases (17 deaths)

Dane 42,069 (+32) (288 deaths)

Dodge 11,558 cases (+2) (159 deaths) (+1)

Door 2,522 cases (+8) (21 deaths)

Douglas 3,750 cases (30 deaths)

Dunn 4,394 cases (+11) (30 deaths)

Eau Claire 11,247 cases (+20) (105 deaths)

Florence - 430 cases (12 deaths)

Fond du Lac 12,082 cases (+9) (104 deaths)

Forest - 936 cases (State revised, decrease of 1) (23 deaths)

Grant 4,737 cases (+9) (83 deaths)

Green 3,364 cases (+11) (16 deaths)

Green Lake - 1,536 cases (18 deaths)

Iowa - 1,952 cases (+2) (11 deaths)

Iron - 567 cases (21 deaths)

Jackson - 2,579 cases (+1) (26 deaths)

Jefferson 8,047 cases (+11) (105 deaths)

Juneau - 3,038 cases (21 deaths)

Kenosha 14,974 cases (+5) (304 deaths) (+1)

Kewaunee 2,304 cases (cases revised -2 by state) (24 deaths)

La Crosse 12,412 cases (+6) (80 deaths)

Lafayette - 1,499 cases (+2) (6 deaths)

Langlade - 1,943 cases (+1) (32 deaths)

Lincoln 2,947 cases (+3) (60 deaths) (+2)

Manitowoc 7,359 cases (+3) (68 deaths)

Marathon 13,886 cases (+14) (184 deaths)

Marinette - 4,001 cases (+1) (65 deaths)

Marquette 1,328 cases (21 deaths)

Menominee - 789 cases (11 deaths)

Milwaukee 100,722 (+116) (1,260 deaths) (+2)

Monroe 4,378 cases (+1) (34 deaths)

Oconto 4,314 cases (49 deaths)

Oneida - 3,502 cases (+4) (69 deaths)

Outagamie 19,884 cases (+28) (199 deaths) (+1)

Ozaukee 7,854 cases (+6) (81 deaths)

Pepin 817 cases (+1) (7 deaths)

Pierce 3,621 cases (+4) (35 deaths)

Polk 4,029 cases (+2) (44 deaths)

Portage 6,542 cases (+3) (66 deaths)

Price 1,175 cases (+1) (7 deaths)

Racine 20,673 cases (+13) (336 deaths) (State revised, decrease of 1)

Richland - 1,272 cases (15 deaths)

Rock 14,782 cases (+19) (164 deaths)

Rusk - 1,273 cases (16 deaths)

Sauk 5,483 cases (+8) (44 deaths)

Sawyer - 1,571 cases (+5) (23 deaths)

Shawano 4,607 cases (+1) (69 deaths)

Sheboygan 13,264 cases (+21) (133 deaths)

St. Croix 6,775 cases (+18) (47 deaths)

Taylor - 1,810 cases (+5) (23 deaths)

Trempealeau 3,460 cases (+2) (38 deaths)

Vernon 1,875 cases (38 deaths)

Vilas - 2,193 cases (39 deaths)

Walworth 9,043 cases (+12) (135 deaths)

Washburn 1,354 cases (+4) (18 deaths)

Washington 14,065 cases (+7) (141 deaths) (+2)

Waukesha 42,031 cases (+56) (501 deaths) (+2)

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30% of Wisconsin residents have received COVID-19 vaccine - WEAU

Covid-19 Vaccination Cards Are the Only Proof of Shots, Soon an Essential – The Wall Street Journal

April 1, 2021

Millions of adults vaccinated against Covid-19 have little to prove it beyond a paper card they received at inoculation sites.

The U.S. has no central database for immunizations. States maintain an incomplete patchwork of records. Nor is there standard proof of Covid-19 vaccinations like the yellow-fever cards that are required for travel to many countries where that disease remains prevalent.

With some countries and businesses preparing to make digital proof of vaccination a requirement for entry and travel, the paper cards may be the only ticket to access those platforms. Proof is already being requested on some first dates and at weddings.

Im glad we prioritized getting shots in arms, said Ami Parekh, chief medical officer at digital healthcare company Grand Rounds Inc., which acts as a kind of medical concierge for patients. But putting in rules about being vaccinated without giving people a way to properly track it is a little bit backwards.

The cards themselves are a patchwork of formats. The Centers for Disease Control and Prevention has designed a version, which many locations use, but it isnt required. State and local authorities and even individual sites are devising their own cards to hand out. With no official standard, it may be hard to say what constitutes proof.

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Covid-19 Vaccination Cards Are the Only Proof of Shots, Soon an Essential - The Wall Street Journal

Covid-19 vaccines finally reach CNY doctors offices, where familiar faces give the shots – syracuse.com

April 1, 2021

Syracuse, N.Y. The St. Josephs Health primary care offices placed an order Jan. 11 for 1,200 Covid-19 vaccines for patients at its six physicians offices.

On Friday, the first batch of 600 doses finally arrived, and theyll all be gone by this week.

Over the past week, Central New York doctors offices have received the first shipment of vaccines to directly administer in their offices. The hundreds of doses are a trickle compared to the state-run mass vaccination sites that give thousands of shots a day, but its a big relief for patients intimidated by online signups and sprawling, busy clinics like the state fairgrounds.

This is reaching patients who want to get it from their physician directly, said Julianne Himes, chief executive officer of St. Josephs Physicians. Some of our older patients feel more comfortable having it from somebody theyre familiar with, from the nurse who always gives them their shots.

Many elderly patients also dont drive or have other transportation issues, and they are often uncomfortable going to the big vaccination sites like the OnCenter or fairgrounds.

They see them as big and daunting, and theyre worried about parking, said Himes, a physician assistant.

Doctors have been clambering for the vaccines since the first doses were released in December. The state Department of Health chose instead to funnel the vaccine to large sites capable of giving thousands of shots a day. In a 48-hour period earlier this month, the Expo Center clinic at the state fairgrounds administered more than 18,600 Pfizer and Johnson & Johnson vaccines.

While doctors waited for doses in February and March, Onondaga County allotted a selected number of vaccine appointments to doctors offices to get their most vulnerable patients vaccinated. The St. Josephs practice got 100 slots, so they worked the phones to schedule patients, Himes said.

Having the doses in the office gives patients more comfort and flexibility, doctors say. Marcellus Family Medicine this week got its first 100 doses of the Johnson & Johnson vaccines, and theyre already spoken for.

Its not much, but its definitely been able to allow us to vaccinate people who have not been able to get signed up, said Dr. John Alley, one of two doctors at the Marcellus practice. Its also allowed us to vaccinate some of our homebound, at-risk patients who cannot get to a vaccination center.

Alley drove to the homes of two patients to administer their shots.

We make house calls, he said.

The Johnson & Johnson vaccine makes those house calls a little easier because its just one shot, unlike the Pfizer and Moderna, which each require two injections given weeks apart.

Giving Covid-19 shots in the office is a logistical challenge. A vial of Moderna, the vaccine being used by St. Josephs, contains 10 doses that must be used within six hours of opening. To make sure doses dont go to waste, St. Josephs created a separate area and dedicated staff to in-office vaccination clinics at its busiest locations, Liverpool and Fayetteville.

There have been a handful of no-shows, Himes said, but those extra doses were given to other patients who met the states eligibility criteria, she said.

We have pulled patients from the practice who were there for a visit with their doctor and asked if they wanted to receive the vaccine, she said. In all cases we were able to use our doses from those.

Medical practices said they dont know when theyll get more vaccines. Demand is likely to increase next week, when the state opens eligibility to all New Yorkers 16 years and older.

While family doctors are giving few shots now, they may become increasingly important as the supply of vaccine exceeds those who want or are willing to get one. Some experts fear that vaccine hesitancy the reluctance or refusal of people to get what some consider a rushed or incompletely tested medicine could slow efforts to bring the pandemic under control.

Through trusted relationships with patients, doctors can chip away at that hesitancy, said Dr. Mitchell Brodey, chief executive officer of the Family Medical Care Group.

When you go to your doctor, you trust the doctor, said Brodey, whose sprawling group started giving vaccines last week. If your doctor says do it, youll do it.

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Covid-19 vaccines finally reach CNY doctors offices, where familiar faces give the shots - syracuse.com

29 March 2021 The J&J COVID-19 vaccine: What you need to know – World Health Organization

April 1, 2021

The WHO Strategic Advisory Group of Experts (SAGE) on Immunisation has issued Interim recommendations for the use of the Janssen Ad26.CoV2.S vaccine against COVID-19.

Here is what you need to know.

This article provides a summary of the interim recommendations; the interim recommendations and the background document are also available.

While COVID-19 vaccine supplies are limited, health workers at high risk of exposure and older people should be prioritised for vaccination.

Countries can refer to the WHO Prioritization Roadmap and the WHO Values Framework as guidance for their prioritization of target groups.

The vaccine is safe and effective in people with known medical conditions associated with increased risk of severe disease, such as hypertension, chronic lung disease, significant cardiac disease, obesity, and diabetes.

Persons living with human immunodeficiency virus (HIV) are at higher risk of severe COVID-19 disease. This population group was included in clinical trials and no safety concerns were observed. It is recommended that known HIV-positive vaccine recipients be provided with information and counselling prior to vaccination. Further studies are needed to assess vaccine efficacy for persons with HIV; it is possible that the immune response to the vaccine may be reduced which would lower the vaccines effectiveness.

The J&J vaccine can be offered to people who have had COVID-19 in the past. But individuals may wish to defer their own COVID-19 vaccination for up to six months from the time of SARS-CoV-2 infection, to allow others who may need the vaccine more urgently to go first.

This vaccine can be offered to a breastfeeding woman who is part of a group recommended for the vaccination (e.g. health workers); discontinuing breastfeeding after vaccination is not currently recommended.

While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.

Pregnant women may receive the vaccine if the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks.

For this reason, pregnant women at high risk of exposure to SARS-CoV-2 (e.g. health workers) or who have comorbidities which add to their risk of severe disease, may be vaccinated in consultation with their health care provider.

Who is the vaccine not recommended for?

Individuals with a history of anaphylaxis to any component of the vaccine should not take it.

Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever.

The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies in that age group.

SAGE recommends the use of Janssen Ad26.CoV2.S as one dose (0.5 ml) given intramuscularly.

There should be a minimum interval of 14 days between the administration of this vaccine and any other vaccine against other health conditions. This recommendation may be amended as data on co-administration with other vaccines become available.

How does this vaccine compare to the dual dose vaccines already in use?

We cannot compare the vaccines head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19.

SAGE has thoroughly assessed the data on quality, safety and efficacy of the vaccine and has recommended its use for people aged 18 and above.

This vaccine has also undergone review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) and found to be safe for use.

28 days after inoculation Janssen Ad26.CoV2.S was found to have an efficacy of 85.4% against severe disease and hospitalisation.

A dose of Janssen Ad26.COV2.S was found in clinical trials to have an efficacy of 66.9% against symptomatic moderate and severe SARS-CoV-2 infection.

SAGE has reviewed all available data on the performance of the vaccine in the settings of the variants of concern. In clinical trials this vaccine has been tested against a variety of SARS-CoV-2 virus variants, including B1.351 (first identified in South Africa) and P.2 (first identified in Brazil), and found to be effective.

SAGE currently recommends using this vaccine, according to the WHO Prioritization Roadmap, even if variants of concern are present in a country. As new data becomes available, WHO will update recommendations accordingly.

There is currently no substantive data available related to the impact of Ad26.COV2.S on transmission of virus that causes COVID-19 disease.

In the meantime, we must maintain and strengthen public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds and ensuring good ventilation.

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29 March 2021 The J&J COVID-19 vaccine: What you need to know - World Health Organization

Why U.S. Approval of the AstraZeneca Covid-19 Vaccine Is Taking So Long – Smithsonian Magazine

April 1, 2021

On the evening of March 24, AstraZeneca announced its Covid-19 vaccine is 76 percent effective at preventing symptomatic disease, based on its Phase III trial of over 32,000 participants mostly in the United States. The results concluded a whirlwind of news stories about the AstraZeneca vaccine in March.

At this point, the vaccine has been approved for use in the United Kingdom and several European Union countries since December. It has not yet been approved in the U.S. because the Food and Drug Administration (FDA) asked the company to provide results from a large-scale trial, Umair Irfan reports for Vox. Experts have expected the data to show that the vaccine is safe and effective, but worry how AstraZenecas recent hurdles might impact its reputation around the world.

I think the way that the ship will be righted is by having the FDAs scrutiny, says biostatistician Stephen Evans of the London School of Hygiene & Tropical Medicine to Smriti Mallapaty and Ewen Callaway at Nature. Evans expects the vaccine will be approved when the FDA is able to review the raw data.

On March 18, the European Medicines Agency (EMA) completed its review of the AstraZeneca vaccine, which is made in partnership with Oxford University, and concluded that it is safe and effective, BBC News reports. The E.U.s medical regulation agency had revisited the vaccines safety because, out of about 17 million people who had gotten the shot by early March, 37 people developed unusual blood clots.

More than 20 countries suspended use of the vaccine while the EMA reviewed the cases, Kai Kupferschmidt and Gretchen Vogel report for Science magazine. Most countries resumed vaccine use after the EMA concluded that it is safe, but last week Friday, Norway extended its suspension of the vaccine until April 15, Gwladys Fouche and Terje Solsvik report for Reuters. Norwegian officials hope more data about the cause of the blood clots will become available soon.

On March 22, AstraZeneca released its initial results of the Phase III trial, which showed slightly higher effectiveness at preventing Covid-19 than the latest results. The results were long-awaited. The FDA asked the company to conduct a larger trial in order to get clearer data than they gathered in their first rounds of testing. In the first trials in the U.K., some participants unexpectedly received half-doses of the first shot in the vaccine, and the early trials did not include enough people older than 65, reports the Washington Post.

By the morning of March 23, officials at the National Institute of Allergy and Infectious Diseases released a letter from its data and safety monitoring board that's been examining the AstraZeneca trial, Andrew Joseph reports for STAT News. The letter stated that AstraZeneca had used outdated data to reach its efficacy number. The move was unprecedented; usually, monitoring boards keep their correspondence with companies private.

We just felt we could not remain silent. Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didnt want to be in that position, says Anthony Fauci, director of the NIAID, to STAT News. In my mind, its an unforced error by the company.

AstraZeneca explained the initial results included data gathered until February 17, per Nature.

Within 48 hours, AstraZeneca released its revised results with updated data. According to the statement, the vaccine has 76 percent efficacy at reducing symptomatic Covid-19 overall, and 85 percent efficacy in people 65 years old and older. A specific review of the 32,000 participants in the U.S. trial found no cases of the unusual blood clots that caused hesitation in Europe, per STAT News.

The benefits of these results will mainly be for the rest of the world, where confidence in the AstraZeneca vaccine has been eroded, said Evans to the New York Times.

AstraZeneca plans to submit the data for emergency use authorization in the coming weeks and then the FDA additional time to review the data and make its decision.

The AstraZeneca vaccine may not have a large role in vaccinating people in the United States because the three companies already approved to supply vaccines in the country agreed to provide enough doses for anyone who wants one this year. But AstraZeneca is participating in the COVAX program to provide doses to low- and middle-income countries for no profit, and FDA approval is a global gold-standard for safety of medications.

At the end of the day, the FDA looks at the data, not the press releases, says the FDAs former chief scientist Jesse Goodman to Vox. Looking at that data and doing their own analysis is whats going to determine whether this vaccine gets an [emergency use authorization], whether the benefits outweigh the risk.

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Why U.S. Approval of the AstraZeneca Covid-19 Vaccine Is Taking So Long - Smithsonian Magazine

COVID-19 vaccine 90% effective in real-world study in Duluth, seven other sites – Minneapolis Star Tribune

March 30, 2021

A federal study with support from Duluth researchers has tracked the first two COVID-19 vaccines approved in the U.S. and found that they were 90% effective in real-world conditions and prevented asymptomatic infections.

Clinical trials of the Moderna and Pfizer vaccines looked only at prevention of symptomatic infections, so the latest study of their effectiveness in health care and emergency medical workers is a significant advance, said Dr. Harmony Tyner, an infectious disease specialist at St. Luke's Regional Health Care System in Duluth.

"It protects against asymptomatic infections as well," said Tyner, a co-author of the study published Monday by the U.S. Centers for Disease Control and Prevention. "We know it kept people alive, we know it kept people from dying, but [the clinical trials] didn't test against asymptomatic infections, which is huge."

The finding is a boost for aggressive vaccination as a key response to the pandemic in Minnesota, where there have been 6,835 COVID-19 deaths and 516,608 diagnosed infections with the novel coronavirus that causes the disease. The totals include five deaths and 1,550 infections reported on Monday amid continued signs of a new COVID-19 wave in Minnesota.

The state on Monday reported that 1,609,277 people have received a first dose of COVID-19 vaccine and 990,854 have completed the series either by receiving two Moderna and Pfizer shots or a single-dose of Johnson & Johnson vaccine.

All Minnesotans 16 and older will technically be eligible Tuesday to receive vaccine, but quantities remain limited and many medical providers are continuing to reserve doses for those at greatest risk of viral exposure or severe COVID-19 illness.

Gov. Tim Walz and former Gov. Tim Pawlenty are publicly receiving J&J vaccine shots on Tuesday.

The state reported that 81% of senior citizens and at least 66% of K-12 and child-care educators have received vaccine. They were initial priority groups in Minnesota along with long-term care residents, health care workers and non-elderly adults with qualifying medical conditions or front-line occupations.

Duluth is among eight locations that took part in one of the first real-world COVID-19 vaccine effectiveness studies in the U.S. The Minnesota site provided 448 volunteers, mostly clinic and hospital workers but some first responders as well, who submitted to COVID-19 testing every week before and after they were vaccinated.

Only 12 infections were detected between Dec. 14 and March 13 in the local study group, which included 47 people who were unvaccinated. That 2.7% infection rate was one of the lowest in the study and could have been due to the high vaccination rate in the group or due to higher viral transmission during the study period in other locations such as Arizona, Florida and Texas, Tyner said.

Among the 3,950 participants from all eight U.S. sites, 205 SARS-CoV-2 infections were identified a rate of 5.2%. One-fourth of the study group remained unvaccinated during the study period.

The results showed 90% effectiveness for people who had been fully vaccinated which means it had been 14 days after their final doses and 80% effectiveness for partially vaccinated individuals, according to the CDC report. Clinical trials of the Moderna and Pfizer vaccine had shown about 95% effectiveness for fully vaccinated individuals.

"These findings should offer hope to the millions of Americans receiving COVID-19 vaccines each day and to those who will have the opportunity to roll up their sleeves and get vaccinated in the weeks ahead. The authorized vaccines are the key tool that will help bring an end to this devastating pandemic," Dr. Rochelle Walensky, CDC director, said in a statement.

The study also found a much lower rate, at 10% of infections, with the SARS-CoV-2 virus that were asymptomatic. Estimates of such cases had been at 40% or higher, but Tyner said most people in the study who tested positive in the absence of symptoms ended up developing them later on.

Positive vaccine news could bolster new Minnesota advocacy campaigns, which were delayed until the state expanded access. Roughly 3.5 million Minnesotans already are eligible, but the latest expansion added 900,000 mostly young, healthy adults. The Minnesota Twins on Monday posted a "roll up your sleeves" social media message featuring Nelson Cruz and other star players.

Minnesota is gradually rolling back mobility restrictions designed to limit COVID-19 transmission with the latest changes coming Thursday with allowances for large indoor and outdoor events at limited capacities. That includes Twins games for up to 10,000 fans, which is roughly 25% of the capacity of Target Field.

Proof that vaccines reduce asymptomatic infections could affect other public health responses, including mask-wearing practices for vaccinated people.

The CDC recently permitted unmasked visits without social distancing between fully vaccinated people, who also could visit with unvaccinated people at low risk of developing severe COVID-19.

However, the CDC has recommended mask-wearing in public for fully vaccinated people out of caution because there was no evidence about their risks of spreading the virus through asymptomatic infection and Minnesota's mask mandate applied to them as well.

The CDC study, titled HEROES-RECOVER, is ongoing and will continue to assess vaccine effectiveness over time. Tyner said the Duluth arm is looking for more volunteers in health care and first-responder roles who haven't been vaccinated yet and are willing to be tested regularly. Send a note to recoverstudy@slhduluth.com to sign up.

Health officials remain concerned about a new wave of COVID-19 fueled in part by spring break travels as well as the spread of more infectious variants of the novel coronavirus. Genomic sequencing has shown an increasing rate of infections in Minnesota due to a B.1.1.7 variant that has been problematic in Europe.

Daily pandemic totals in Minnesota have always been lower on Mondays due to reduced testing and reporting activities on weekends. Monday's total was the highest for a Monday since Jan. 4.

The key question for state health officials is whether the increase in diagnosed infections will be followed by more hospitalizations and then deaths a pattern in the spring and fall that might not be repeated due to vaccination progress.

COVID-19 hospitalizations in Minnesota had increased from 210 on March 6 to 366 on March 26. The total dropped to 343 on Sunday.

Jeremy Olson 612-673-7744

Original post:

COVID-19 vaccine 90% effective in real-world study in Duluth, seven other sites - Minneapolis Star Tribune

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