FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines – FDA.gov

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines – FDA.gov

Data shows Ohio’s COVID-19 vaccination rollout beginning to pick up steam – News 5 Cleveland

Data shows Ohio’s COVID-19 vaccination rollout beginning to pick up steam – News 5 Cleveland

January 5, 2021

CLEVELAND After what Gov. Mike DeWine characterized last week as a slow start to the COVID-19 vaccine rollout across Ohio, the inoculation effort has started to pick up steam, according to state vaccination data. In less than a week, the number of Ohioans to receive the vaccine has more than doubled to just over 162,000.

ODH

Although the total number of people vaccinated still accounts for only a small part of the population, the progress reflects a positive turning point in the creation of the infrastructure needed to keep the largest vaccination effort in state and US history moving. The vaccination progress made on the state level is also mirrored on the local level, said Dr. Dan Simon of University Hospitals.

I think we have really picked up a head of steam now. We will exhaust our first vaccine allocation by Thursday, Dr. Simon said. We will have vaccinated over 14,000 healthcare workers by Thursday.

The state of Ohio received and shipped a total of 341,000 first doses of the Moderna vaccine and nearly 10,000 first doses of the Pfizer vaccine. Ohio has also recently shipped nearly 10,000 doses of the second round of the Pfizer vaccine. The remaining 170,000 vaccines the state has distributed have been designated as part of the long term care program.

Last week, Gov. DeWine implored health departments and hospital systems to increase the rate at which people are vaccinated, stressing that it was their moral imperative' to move as quickly as possible.

We call it around here go slow to go fast. You want a deliberate method that gets the glitches out before you open the doors, Dr. Simon said. It's like that saying, measure twice, cut once. If you are careful upfront and you get it right, you can really power through. Today, well do 1,800 (vaccinations) across the health system.

Health leaders across the state and nation have stressed that the initial rollout of the vaccine is one of the largest logistical endeavors in recent memory. In addition to shipping and storing the vaccines, which require special refrigeration considerations, the logistics involved in distributing the doses rely simply on having the vaccine available, Dr. Simon said.

The critical thing from a health system standpoint is vaccine delivery. You cant schedule appointments its a logistical nightmare to just cancel them if you dont have the vaccines on hand, Dr. Simon said. Having vaccine in hand is the critical piece right now. The disappointing issue is vaccinating 20 million people by Dec. 31st just didnt happen because there werent 20 million doses.

The actual vaccination process also includes a 15-minute observation period for people with no history of allergic reactions. A 30-minute observation period is required for those with histories of severe allergic reaction.

In a virtual press briefing on New Years Eve, Cuyahoga County Health Commissioner Terry Allan stressed that the initial rollout of the vaccination effort will come with some bumps in the road, but the agency has grown accustomed to working with its partners. As of Monday, more than 18,000 people have been vaccinated, according to state data. The CCBH received its allotment of 4,000 Moderna vaccines just before Christmas.

Weve never done this type of pandemic response for vaccination. Its been 100 years, Allan said. Were learning and building as we go along. Its going to require patience from all of us.


Read more from the original source:
Data shows Ohio's COVID-19 vaccination rollout beginning to pick up steam - News 5 Cleveland
CT Healthcare Workers Get Second Dose of COVID-19 Vaccine – NBC Connecticut

CT Healthcare Workers Get Second Dose of COVID-19 Vaccine – NBC Connecticut

January 5, 2021

Some Connecticut healthcare workers who received their COVID-19 vaccine a few weeks ago received their second dose Monday.

Officials from Hartford HealthCare began to administer the second and final dose of the Pfizer BioNTech vaccineto the first group of frontline health care workers Monday.

The state is focused on the COVID-19 vaccine rollout and by the end of this week, thousands of nursing home residents are expected to receive their first dose.

Health care workers and residents and staff of nursing homes are in the first group in Connecticut to receive the vaccination.

Keith Grant, senior system director of infection prevention atHartford HealthCare, was among the the first people in the state to get the vaccine.

"I've had no side effects," Grant said on Monday at a news conference. He said the majority of the people who have received the vaccine had had some discomfort at the injection site that subsides within 24 to 48 hours.

Hartford HealthCare officials said they have vaccinated more than 13,000 people so far and expect the speed of distribution to continue to increase.

An advisory group is expected to recommend to Gov. Ned Lamont this week which Connecticut residents should receive the next round of COVID-19 vaccinations.

Dr. Deidre Gifford, the acting public health commissioner, said the Centers for Disease Control and Preventions immunization advisory committees recommendation that frontline essential workers and people over the age of 75 be included in phase 1B will be the foundation for Connecticuts plan.

They may opt to make some additions to that group. But I dont want to speculate on what theyre going to advise until after theyve met, said Gifford, who expects Lamont will have the recommendations by Thursday. The group is scheduled to meet Tuesday.

State officials previously said they expected critical workers, those living in other congregate settings, adults over age 65 and high-risk people under age 65 would be eligible for vaccination in the phases between January and May, but the list had not yet been finalized.

LX, or Local X stands, for the exponential possibilities of storytelling in our communities.

Lamont said last week that he is pleased so far with the pace of vaccinations in Connecticut, despite reports of a slow rollout in other parts of the country.


See the original post here:
CT Healthcare Workers Get Second Dose of COVID-19 Vaccine - NBC Connecticut
France struggles with public’s wariness of COVID-19 vaccine – Los Angeles Times

France struggles with public’s wariness of COVID-19 vaccine – Los Angeles Times

January 5, 2021

When 66-year-old cardiologist Jean-Jacques Monsuez slipped one arm out of his blue-and-white checked shirt and offered it to a nurse holding a syringe filled with the Pfizer COVID-19 vaccine, he was doing what many in the world plan to do as soon as they have the chance.

Just not in France.

This may be the land of Louis Pasteur, the scientist renowned for discovering the principles of vaccination. But it is also one of the most reluctant nations in the world to get the COVID-19 shot, leading to the lowest uptake so far of any developed country to start inoculating its citizens.

In the first six days after the vaccine was rolled out Dec. 27 across Europe in a coordinated European Union effort, just 516 people received shots in France such a low number out of a population of 67 million that it is statistically indistinguishable from zero. By contrast, Germany vaccinated more than 200,000 of its residents in the first week and Italy more than 100,000.

For Monsuez, the decision to get the injection was an obvious one, both for his own safety and that of his family and patients.

There is a duty. You see one sick person after another, he said, adding: It didnt hurt. I felt the same before and after.

But many of his compatriots appear not to agree. In a poll conducted last month by Ipsos Global Advisor, in conjunction with the World Economic Forum, only 40% of French residents said they intended to get vaccinated. That put France dead last out of the 15 nations surveyed, in stark contrast to countries such as Britain and the U.S., where 77% and 69% of respondents, respectively, are eager to be inoculated.

The Gallic hesitancy springs from various factors. Many here cite concern over potential side effects and the speed with which the vaccines were developed. Distrust of the government has risen following missteps in its handling of the pandemic and from memories of previous health and vaccine scandals in France.

A cumbersome consent process has bogged down the vaccination campaign in some instances. And prominent healthcare professionals have complained of the lack of a clear official strategy for rolling out the vaccines and for convincing people of their value and efficacy.

Over the weekend, President Emmanuel Macron who survived his own bout with COVID-19 promised that the pace of vaccination would pick up quickly and powerfully, and authorities added healthcare workers over 50 to the list of those eligible for the shot.

Anne Muraro, an art advisor, is in no hurry to join the queue. We dont know the secondary effects, said Muraro, 50. Its too fast. There is not enough hindsight.

Muraro cited the new messenger RNA technology in the Pfizer-BioNTech vaccine as a cause for unease. The same technology is also used in the Moderna COVID-19 vaccine, which has not yet been authorized for use in Europe. Many in France worry that the vaccine was rushed to the market in part for the financial benefit of big pharmaceutical companies.

While such qualms might be understandable given the relatively short time the vaccine has been in circulation, they dont reflect the medical communitys understanding of vaccine development and approval, said Catherine Hill, a retired epidemiologist in Paris. And the gravity of the public health emergency facing France demands that people step up for the COVID-19 shots, she said.

The country is one of the hardest-hit in Europe, with 2.7 million confirmed coronavirus cases and 65,164 deaths, according to a tally by Johns Hopkins University. After two complete lockdowns, residents are currently under curfew, and bars, restaurants and cultural attractions remain closed. Officials have promised to ease these restrictions once the number of new cases drops below 5,000 per day, a target that still seems a long way off.

This virus is killing 400 people per day in France, Hill said. Imagine a big airplane falling out of the sky every day.

In a television interview over the weekend, French Health Minister Olivier Veran defended the slow pace of vaccinations and said France would catch up with its European neighbors by the end of the month.

Verans management of the coronavirus crisis has inspired some mistrust among his compatriots. Early on, he said masks were unnecessary for the general public. Mask-wearing has since become mandatory, and many in France believe his initial counsel against it rose from a supply shortage that the government didnt want to exacerbate rather than out of sound health policy.

As for vaccinations, a spokeswoman for the health department said it would not be useful to start a public information campaign now because most in France wont be eligible for a shot until the spring, after priority is given to residents in nursing homes and to front-line healthcare workers.

French Health Minister Olivier Veran, left, talks to a woman as he arrives to attend the vaccination of health workers at the Hotel Dieu hospital in Paris on Monday.

(Martin Bureau / AFP/Getty Images)

The countrys recent history with new vaccines has sparked some public skepticism. In late 2009, the French government ordered far too many doses of the H1N1 flu vaccine, for which there was little demand, leading to accusations of financial mismanagement.

More pertinently, there were concerns that the hepatitis B vaccine being given in France in the 1990s was tied to an increase in multiple sclerosis. Multiple studies examined the link, with varying conclusions. In 2002, the World Health Organization affirmed that, despite a slightly elevated odds ratio observed in the initial studies, none showed a statistically significantly elevated risk. Many here remain unconvinced.

Edvart Vignots sister developed MS after receiving the hepatitis B vaccine, which is partly why he prefers to wait to see what side effects the COVID-19 vaccine may have before letting anyone stick a needle in his arm. Vignot, who is Muraros partner, also wants to hear what scientists not linked to governments or pharmaceutical companies have to say.

We need other people, he said, independent experts.

Also key is winning over family doctors and pharmacists, on whom the French lean heavily for advice. Eliette Gauthier, who lives in a suburb of Bordeaux, said she is still not sure whether she will get vaccinated, largely because her doctor told her he doesnt yet have enough information to counsel her one way or the other.

We dont have enough information about the composition of the shots, the 71-year-old retired schoolteacher said. Im going to see what my doctor advises.

Frances inoculation campaign has further been bogged down by a complex consent process that has mandated pre-vaccination consultations with patients to ensure their consent. Because the campaign is currently targeting the elderly in retirement homes, some of whom suffer from cognitive issues, the process has been particularly laborious.

In the meantime, both Muraro and Vignot are taking other preventive measures, such as observing social distancing, wearing masks and taking vitamin D, which some experts believe helps ward off infection. The couple has long since given up shaking hands or greeting friends with kisses on the cheek, as was the French habit until the pandemic broke out.

Newsletter

Get our free Coronavirus Today newsletter

Sign up for the latest news, best stories and what they mean for you, plus answers to your questions.

Enter Email Address

Sign Me Up

You may occasionally receive promotional content from the Los Angeles Times.

And both have already had the coronavirus, leading them to believe that they probably have some level of immunity for the time being.

Muraro said she would revisit taking the vaccine in the fall, when she will likely be eligible and when the risk of transmission is likely to rise as colder weather spurs people to move indoors.

Frederic Adnet, head of the emergency medicine at the Avicenne Hospital in the suburbs north of Paris, believes that most people in France are like Muraro and Vignot: not flat-out refusing to take the vaccine but adopting a wait-and-see approach.

When they see its effective and safe, opinions will change, Adnet said, adding that high rates of vaccination in the U.S. and the U.K. should help boost public confidence here. I think the French are reasonable, and in two months you will see that we are all yelling that there isnt enough vaccine.

El-Faizy is a special correspondent.


Read more:
France struggles with public's wariness of COVID-19 vaccine - Los Angeles Times
UAB researcher develops technology to aid COVID-19 vaccine immunity monitoring – The Mix

UAB researcher develops technology to aid COVID-19 vaccine immunity monitoring – The Mix

January 5, 2021

In advance of public vaccination, a quick and accurate COVID-19 antibody test will help determine the presence of neutralizing antibodies, the molecules that aid in protection against the virus.

In advance of public vaccination, a quick and accurate COVID-19 antibody test will help determine the presence of neutralizing antibodies, the molecules that aid in protection against the virus.As the COVID-19 vaccine becomes available to the public, immunity monitoring will play an important role in determining whether the vaccine is effective for an individual, and for how long. Benjamin Larimer, Ph.D., researcher at the University of Alabama at Birmingham, has developed a technology with potential use as an in-home antibody test.

Larimers diagnostic test is an accurate and reliable method for determining whether individuals are protected against COVID-19. The technology identifies neutralizing antibodies those that block the virus from infecting cells. Emerging research suggests neutralizing antibodies offer the best protection against the virus.

The most widely used antibody tests today do not specifically identify neutralizing antibodies. Currently, these neutralizing antibodies can only be measured at a high level of accuracy using complicated and time-consuming laboratory tests not available to the general public.

According to Larimer, existing antibody tests use a broad approach to locating antibodies, which attach to very small and distinct pieces of the virus. Current tests can mistake antibodies for other viruses, such as the common cold, for COVID-19 antibodies, leading to possible false-positive results.

To create the new test, Larimer began breaking down the COVID-19 virus into small pieces to identify the exact locations where antibodies attached to the virus. The results were better than Larimers team anticipated, with the test detecting 20 percent more positive cases than the current gold-standard clinical antibody test. The ability to specifically recognize even small amounts of antibodies accurately is an important achievement, according to Larimer.

The goal of every vaccine is to get the body to produce antibodies, which serve as a first line of defense against the virus, said Larimer, an assistant professor in the UAB Department of Radiology Division of Advanced Medical Imaging Research. Tests that specifically detect these antibodies can be used to measure whether a vaccine works, and possibly predict how long its protection will last.

Benjamin Larimer, Ph.D.Immunity to COVID-19 is not anticipated to last forever, and immunity monitoring could continue for several years, even after widespread administration of a vaccine.

Clinical trials indicated that COVID-19 vaccines may be remarkably successful; however, even 95 percent effectiveness will leave millions of Americans unprotected. Antibody testing helps determine efficacy and should help indicate whether a person is protected against the virus.

Larimer hopes to transition his teams technology to an inexpensive and easy-to-use test that will provide in-home immunity monitoring for the general public.

P3 Diagnostics, LLC, was formed in 2020 by Larimer and co-founders Joe Gay and Chris Paule. The startup serves to foster the business development of technology created under the direction of Larimer and the Larimer Lab.


Read more here: UAB researcher develops technology to aid COVID-19 vaccine immunity monitoring - The Mix
Teachers will receive COVID-19 vaccine in phase 1B – WLOX

Teachers will receive COVID-19 vaccine in phase 1B – WLOX

January 5, 2021

I believe its a good thing. Itll get the kids back. Our goal is to get all the kids back into the classroom, Banks said. So me taking the vaccine, it will make my job a lot better, a lot less stressful, to know that Im protected.


Visit link:
Teachers will receive COVID-19 vaccine in phase 1B - WLOX
Covid-19 Vaccines Are in High Demand, but Thousands More Workers Are Needed to Make Them – The Wall Street Journal

Covid-19 Vaccines Are in High Demand, but Thousands More Workers Are Needed to Make Them – The Wall Street Journal

January 5, 2021

SEOULContract-manufacturing companies working to accelerate the global availability of Covid-19 vaccines are struggling with a shortage of their own: There arent enough workers to meet this years big production push.

The talent pool is so tight that Emergent BioSolutions Inc., a Covid-19 contractor based in Gaithersburg, Md., for AstraZeneca PLC and Johnson & Johnson , enlisted its CEO and a half-dozen other senior executives to pitch potential hires at a virtual career fair in October. More than 550 people attended.

Not enough of them were swayed. More than two months later, Emergent still has roughly 200 openings for warehouse associates, quality-assurance analysts and even a supply-chain management director. Hiring and ramping up has become challenging, said Sean Kirk, an Emergent executive vice president, who spoke at the event.

Outsourcing companies such as Emergent make about one-sixth of complex treatments including vaccines, but the scale and abruptness of Covid-19 shots is likely to boost that share much higher, say industry executives and experts. With demand dwarfing supply, Pfizer Inc., Moderna Inc. and others are turning to contract manufacturers for assistance in what is the largest pharmaceutical rollout in modern history.

But those helping drugmakers need more help themselves. More than 5,000 open jobs exist at the worlds 10 largest companies that have won Covid-19 outsourcing work, according to a Wall Street Journal analysis of the companies websites. The firms were ranked by production capacity.


See the original post: Covid-19 Vaccines Are in High Demand, but Thousands More Workers Are Needed to Make Them - The Wall Street Journal
Gavin Newsom press conference today: Governor explains why COVID-19 vaccine rollout is going slowly in California – KABC-TV
Many frustrated with how fast COVID-19 vaccine appointments fill up – WAFB

Many frustrated with how fast COVID-19 vaccine appointments fill up – WAFB

January 5, 2021

Its been a crazy day, our phone has been ringing off the hook, in fact, we had so many phone calls come in today that it shut down our phone system for a while. But were back up and running and weve gotten over 100 phone calls from people that are interested in getting the vaccine, said Michelle McCalope the Communications Director at CareSouth Medical and Dental in Baton Rouge.


See the article here:
Many frustrated with how fast COVID-19 vaccine appointments fill up - WAFB
Here’s how you can sign up for the COVID-19 vaccine in Winnebago County – WREX-TV

Here’s how you can sign up for the COVID-19 vaccine in Winnebago County – WREX-TV

January 5, 2021

WINNEBAGO COUNTY (WREX) We continue to learn more about the plan to administer the COVID-19 vaccine to the general population in Winnebago County.

Dr. Sandra Martell, the Public Administrator with the Winnebago County Health Department, says the health department launched an online registration tool for the vaccine over the holiday weekend.

RELATED: COVID-19 positivity rate increases three straight days in Region 1; now over 10 percent

Dr. Martell says it is not a first-come-first-serve basis for those who register, but it will help determine those who will get vaccinated based off someone's risk/occupation. Dr. Martell says because of this, households may not get vaccinated at the same time.

The online registration tool is designed to help set reminders for appointments and recalls for those who miss appointments. The tool was also designed to enable trust with the community, according to Dr. Martell.

It was also set up to help eliminate data entry errors by health officials.

Once you sign up through the registration tool, the information will go to the state's database as well, to ensure no one is getting the vaccination more than once.

More than 4,500 people have registered as of Monday afternoon, according to Dr. Martell.

The registration site does support multiple languages.

To register for the COVID-19 vaccine, click either one of the links below:

"We're hoping this will allow us to have efficient use of our staff as well to provide vaccination, rather than to set up appointments and scheduling and having people sign up and stand in line like they are in Florida or Texas lining up in cars. Our goal is to be efficient with the use of your time and the use of staff time to effectively use our staff to vaccinate," Dr. Martell said.

The state is currently still in phase 1A for giving the vaccine, meaning healthcare workers and those on the frontlines. Dr. Martell says the state is likely to be in phase 1A through mid-January at least.

Dr. Martell says there's been approximately 6,200 people in Winnebago County who have received the vaccine thus far.

Also on Monday, health officials announced 424 new cases of the virus in Winnebago County from Friday-Monday, including a 7-month-old child. There's now been 23,309 confirmed cases in Winnebago County since the pandemic started.

The county also reported 3 more deaths, bringing the county's death toll up to 361 since the pandemic started.


Read the original: Here's how you can sign up for the COVID-19 vaccine in Winnebago County - WREX-TV
Will COVID-19 vaccines accelerate a return to the office? – Chicago Tribune

Will COVID-19 vaccines accelerate a return to the office? – Chicago Tribune

January 5, 2021

Sikich senior auditor Priyank Shah works alone in a 25,000-square-foot space at the company's office in downtown Chicago, as most of his co-workers work from home, on Aug. 18, 2020. Sikich took the dramatic step of saying its employees could continue remote work indefinitely. (Antonio Perez / Chicago Tribune)


Link:
Will COVID-19 vaccines accelerate a return to the office? - Chicago Tribune