The FDA is expected to authorize Pfizer and BioNTechs Covid-19 vaccine candidate imminently, but President Donald Trump is nevertheless ratcheting up pressure on the agency to move faster, continuing a year of unprecedented political interference in regulatory decisions that have traditionally remained insulated from the White House.
On Friday morning, minutes after FDA commissioner Stephen Hahn and FDA vaccines and biologics chief Peter Marks announced they were finalizing an emergency use authorization for the vaccine, Trump tweeted an attack on the agency and its leader by name.
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The Food and Drug Administration is in the final steps of approving two COVID-19 vaccines prior to shipments being distributed throughout the country, including Nebraska.
Regional West expects the initial stock of the vaccine to be delivered in the next two to three weeks, said Paulette Schnell, Regional West Community Health Director and Scotts Bluff County Health Director.
The vaccine will be distributed in waves. The first wave will have three phases (A,B, and C).
Phase A distribution will go to healthcare and long term care facilities; Phase B will include first responders, the education sector, food and agriculture, corrections staff, and utilities and transportation; while Phase C will include people who are 65 years of age and older, vulnerable populations, and congregate living, including nursing homes.
Future waves of distribution have not been announced, however, vaccine distribution for the general public is anticipated in early spring 2021.
There are different types of vaccines. The first vaccines to provide immunity for the COVID-19 virus will not contain a live virus, but instead will introduce a protein associated with the virus to your bodys immune system. Your body will then create antibodies to combat the virus should you encounter it later, said Regional West Chief Medical Officer Matthew Bruner, MD, FACOG.
The vaccine will be given in two shots, spaced either 21 or 28 days apart, based on which vaccine you receive. You must receive the same vaccine for both shots for it to be effective. Through trials, both vaccines have proven to be 95% effective. That means of those vaccinated for the trials, only 5% developed COVID-19 when exposed to the virus and their symptoms were mild.
We need to continue to practice social distancing and wearing masks when in public, but having the vaccine available will be a game changer, said Dr. Bruner. This will help us move forward and help protect those who are the most vulnerable in our communities.
More information will be provided about general public clinics when available.
by: News Channel 11 Staff
JOHNSON CITY, Tenn. (WJHL) In a memo to employees, Ballad Health Chairman & CEO Alan Levine addressed the fast-approaching release of a COVID-19 vaccine, and if team members will be required to get immunized once the vaccine is available.
The short answer, was not immediately.
In the note to Ballad employees, Levine said in part, Remember, we are not making this vaccine mandatory for Ballad Health team members at this time. We do respect that some may have a desire to wait and see, and feel it is prudent to respect your health care decisions. As you know, we do require the flu vaccine, and that requirement remains in place. Over time, we may revisit this COVID vaccine policy once there is more data from which to provide comfort to those who would prefer to observe the experience of those who have been vaccinated.
Levine did note that when the COVID-19 vaccine becomes available for him, he plans to receive it.
So far, former Presidents Clinton, Bush and Obama have said they plan to take the vaccine on camera to promote its safety, and when it becomes available to me, I intend to do the same, Levine said.
It was mentioned in the memo that the Pfizer/BioNTech vaccine will begin shipping to states within the next 24 hours.
Highest priority will initially be given to hospital based front line health care workers with direct patient exposure or potentially infectious material, and to residents of long term care facilities. Vaccine supply is expected to increase steadily in 2021, and we will act quickly to make the vaccine available to everyone who wants it, Levine said.
In his message to employees Levine also addressed the safety of the vaccine saying in part, During its phase 3 trial of more than 43,000 participants, Pfizer/BioNTech announced its vaccine was 95% effective at preventing mild to severe COVID-19. This is remarkably good news which means we can expect excellent personal protection from vaccination. Studies released earlier this week show the vaccine has a good safety profile.
While Levine stressed the importance of the vaccine he also said, infection prevention measures such as mask wearing and physical distancing will continue to be vital in our fight against this pandemic.
We asked you to tell us your biggest questions about the COVID-19 vaccines. Here are some answers. USA TODAY
A committee crucial for clearing a COVID-19 vaccine will hold an all-day meeting Thursday, and depending on how it votes, the nation's first doses could ship as early as Friday.
The external expert committee will review data from Pfizer and German startup BioNTech on their vaccine, called BNT162b2, and by day's end will vote whether the U.S. Food and Drug Administration should authorize the countrys first COVID-19 vaccine.
The companies are requesting an emergency use authorization, shy of a full approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed. But corners, FDA says, have not been cut.
If the independent Vaccines and Related Biological Products Advisory Committee recommends that authorization, the FDA is expected to sign off on the vaccine, possibly as soon as late Thursday.
'Very inconsistent': 2 allergic reactions in the UK to COVID-19 vaccine puzzle researchers
Another committee, convened by the U.S. Centers for Disease Control and Prevention, will meet Friday and Sunday to officially determine who should receive the first doses. Depending on timing, the first Americans could start to be vaccinated by the weekend, though more likely Monday.
The VRBPAC meeting (pronounced verb-pack), is one of the final pieces in a process that began in January when workbegan on a vaccine to help end the global coronavirus pandemic. Just 10 months later, on Nov. 20, Pfizer and BioNTechbecame the first tosubmittheir application to FDA for general use in the U.S.
Another COVID-19 vaccine, developed by Cambridge, Massachusetts-based Moderna, will go through the same approval processnext week. Its candidate goes before the FDA committee Dec. 17.
No fully vetted vaccinehas ever been developed more quickly. The previous record was four years for one against the mumps.Vaccine developers saved time by conducting steps at the same time that are usually done in sequence.
Despite the swift pace, experts stress the process has been painstaking and methodical, and FDA's scientific experts will comb the data submitted by the companies.Everything is double-checkedand nothing is taken for granted.
They even go through it line by line and check all the math, do all the statistical analyses over again, saidDr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine.
"They're really making sure that no stone left goes left unturned in terms of evaluating the safety and the efficacy of these vaccines," said Dr. William Moss, an epidemiologist with the International Vaccine Access Center.
A vial of the COVID-19 candidate vaccine developed by BioNTech and Pfizer is displayed at the headquarters in Puurs, Belgium.(Photo: AP Images)
The unprecedented speed at which the COVID-19 vaccines have beenbrought to market belies the truth about vaccine development: Most efforts fail.
Only about 1 in 6 make it all the way through approval. Decades of tedious work can be upended by spectacular failuresand the most promising paths can turn into dead ends.
Nature gives up its secrets slowly and grudgingly. Its a constant struggle to prove that a product you think saves lives actually does, said Dr. Paul Offit,director of the Vaccine Education Center at Children's Hospital of Philadelphiaand a professor of vaccinology at the Perelman School of Medicine at the University of Pennsylvania.
Vaccines take years and sometimes decades to develop for a reason. There are so many hoops to jump thatits hard to even count the hundreds of points where something could go wrong and knock a candidate out of the running.
Getting a vaccine has been a huge undertaking. How all 50 states scramble to dole them out is the next massive challenge.
Everyone who works in the field knows they should never get their hopes up.
The nature of vaccine development is there are always surprises, said Poland. After four decades working the field, his advice is expect the unexpected.
Vaccines are first tested in cellsthen in animals.If things go well in animals, the company or researchers working on the vaccine apply to the FDA to test it in a very small number of humans to make sure it doesnt hurt people.
Those first humantests are wheremost vaccine creators hopes and dreams end. What works in animals, theyve learned the hard way, usually doesnt work in people.
The Phase 1 trial is where 90% of vaccines die, said Dr. Corey Casper, CEO of the Infectious Disease Research Institute in Seattle and a professor of global health at the University of Washington.
If a vaccine clears Phase 1, it still can be rejected in larger Phase 2 and the much larger Phase 3 human trials, which are guided by external expert committees with the power of life and death over the process.
Almost 15% of candidate vaccines get bad news when trials expand,according to research by the Massachusetts Institute of Technology.
Its one of the most dejecting feelings. Its like getting a holiday present and theres nothing in the box, said Casper. You feel horrible. Youve done all this work, youve spent all this and youve gotten people to volunteer their time and their bodies and they didnt benefit."
The frontrunning COVID-19vaccines got lucky.
Data fromPfizer/BioNTech's Phase 3 trial showed itprevented 95% of people from becoming sick. Moderna's vaccine, based on the same messenger RNA technology, showed similar effectiveness. The findings bode well for their FDA blessing.
Phil Dormitzer, chief science officer for Pfizers viral vaccine research and development division, received the good news Nov. 9.
He wasat home in Nyack, New York, when he opened his email at 6:15 a.m.and saw the subject line.
Ill be honest with you, it was somewhat overwhelming. I was stopped in my tracks, it was a real rush of emotion, he said.
Later in the day his team held a brief celebratory teleconference but then they went back to work.
To actually get this vaccine authorized, manufactured and distributed," he said, "theres still a huge amount that has to be done."
Contact Elizabeth Weise at eweise@usatoday.com
Answers to your vaccine questions: Are there side effects to a COVID-19 vaccine? What are the 'ingredients'? The cost?
More: Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
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Two Wichita Falls hospitals to receive part of first shipment of COVID-19 vaccine in Texas Times Record News
Public health officials have confirmed that people will be given a COVID-19 Vaccination Record Card after they receive their first dose of the coronavirus vaccine, CNN reports. The documentation will help officials keep track of who has received the shot, and help people follow through with the second dose of their vaccination schedule, Kelly Moore, associate director of the Immunization Action Coalition, told the news outlet.
Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due, Moore explained. Lets do the simple, easy thing first. Everyones going to get that.
Clinics that offer the vaccine will also log patient information in their state immunization registries to track which shot was given, as two vaccine candidates from pharmaceutical giants Pfizer and Moderna are currently pending emergency use authorization from the FDA. This will make it easier for doctors and healthcare providers to find that information if a patient was unsure of their vaccination details, Moore says.
The card will be part of an overall vaccination kit, which will also include a needle and syringe, alcohol wipes, and a face mask.
U.S. Department of Defense
The cards were also mentioned in a press briefing with members of the federal governments Operation Warp Speed. Weve set up everything [in] a draconian process, where when we sent out the ancillary kits which have needles and syringes, weve included paper cards to be filled out and ... given to the individuals, reminding them of their next vaccine due date, Army Gen. Gustave Perna, Warp Speeds chief operating officer, said in the briefing. He added that people will be asked to take a photo of their vaccination cards or to keep them in their wallet.
This isnt a concept unique to COVID-19. Vaccination cards are already distributed when people are vaccinated against certain infectious diseases, including smallpox and yellow fever.
The World Health Organization (WHO) has an international certificate of vaccination or prophylaxis that can be carried by a person who has been vaccinated. I carry a yellow fever card around in my wallet, says infectious disease expert Amesh A. Adalja, M.D., senior scholar at the Johns Hopkins Center for Health Security.
There was a time when pediatricians were giving out vaccination cards to parents after routine childhood vaccines, but so many parents lost them and didnt keep up with them that people gave that up about 25 years ago, says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine. Now, for certain diseases, you have to have a vaccination certificate or card if youre going to certain countries.
A COVID-19 vaccination card will feature a persons first and last name, birthdate, the vaccines name and maker, and the dates of when the first and second dose were received, according to a sample image from the U.S. Department of Defense. (Both vaccines pending approval will require two doses.)
U.S. Department of Defense
Back in April, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said that there were talks of using vaccination cards or certificates for the COVID-19 vaccine. You know, thats possible, he said on CNNs New Day at the time. Its one of those things that we talk about when we want to make sure that we know who the vulnerable people are and not.
Its unclear at this point how COVID-19 vaccine cards will be used, but experts have confirmed that their main purpose is to simply make sure people follow through with the second dose of the vaccine. It will be very important ... for all Americans who get the Moderna or the Pfizer vaccine to have their first vaccine dose and then come back either three or four weeks later to get their second vaccine dose, to complete the immunization schedule, said Moncef Slaoui, M.D., Warp Speeds chief scientific adviser, per NPR.
Moore told CNN that vaccine distribution sites will likely ask you for your cell phone number, so you can also receive a text message to remind you to get your next dose.
Richard Watkins, M.D., an infectious disease physician and professor of internal medicine at the Northeast Ohio Medical University, says the cards might be especially useful for workers that interact with the public and vulnerable populations frequently, like healthcare providers, restaurant servers, and teachers.
Officials have not confirmed that the cards will be used for travel or large events.
Overall, experts say vaccination cards will bring us one step closer to ending the pandemic. Both Pfizer and Moderna have vaccine candidates that are reported to be more than 90% effective at preventing COVID-19 infection in people whole participated in phase 3 clinical trials. The White House Coronavirus Task Force expects the first doses to be administered to healthcare workers and elderly residents of long-term care facilities as soon as mid-December.
It is unlikely that the general public will have access to the vaccine until late spring to summer of 2021, Dr. Adalja says. But when it becomes available to you, its crucial that you get it. Nearly 300,000 Americans have died of COVID-19 so farand getting vaccinated will help save lives. I would be proud to show my coronavirus vaccine card to people, Dr. Adalja says.
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TAHLEQUAH, Okla. (KFOR) A tribal nation says it is set to receive its first doses of the COVID-19 vaccine next week.
The Cherokee Nation says it will receive 975 of the first doses of the Pfizer COVID-19 vaccine next week.
We have been working with IHS and following CDC guidelines to create a prioritization plan that will include our frontline health care workers and those who are at high risk of infection to be among the first to receive the vaccine so that we can get our most vulnerable and at-risk populations vaccinated, said Brian Hail, Deputy Executive Director of External Operations for Cherokee Nation Health Services.
Tribal leaders say they will vaccinate frontline healthcare workers, emergency responders, Cherokee speakers, Cherokee National Treasures, and elders over the age of 65.
Taking a COVID-19 vaccine is another step forward to saving lives among our Cherokee people and helping stop the spread of this deadly virus in our Cherokee communities, Cherokee Nation Principal Chief Chuck Hoskin Jr. said. I know some of our Cherokee elders may have reservations about taking the vaccine, but it will save our elders, our speakers, our National Treasures and frontline workers. As we continue our phased plan and get more doses into 2021 to begin vaccinating our employees and citizens, we can begin the process of healing from what we know is the worst public health crisis our tribe has faced in generations.
Officials say they have made several updates to their facilities in order to keep the COVID-19 vaccines stored properly.
The vaccine will be given in two doses with the second dose given exactly 21 days after the first.
The more of our frontline staff that receive the vaccine puts us in line to receive larger allocations in the future. Use of this first allocation and the time in which we administer it, is very important to benefit our communities moving forward, said Dr. R. Stephen Jones, Executive Director of Cherokee Nation Health Services.
Once the first group of Cherokee citizens is vaccinated, officials say they plan to provide vaccines to non- healthcare critical staff like teachers, childcare providers, food security staff, shelter staff, and those with underlying health conditions.
So far, the Cherokee Nation has had nearly 7,000 positive cases of COVID-19 and 50 deaths, including 20 Cherokee speakers within its health system.
As the COVID-19 vaccine becomes more readily available, the tribe encourages everyone to continue to wear a mask, wash their hands regularly and observe social distancing. The benefit provided by the vaccine will take several months before it decreases the amount of community spread and impact to Cherokee families and communities.
Others who are eager to get the vaccine fret about being low on the priority list. LaMont C. Brown II, a bus driver in Detroit, said the pandemic had exposed just how little his profession was appreciated. While police officers, firefighters and medical workers are treated as heroes, he hears little celebration of drivers who interact with the public, potentially risking their health.
Now he worries that the same dynamic will play out with vaccines.
He has heard that medical workers and other emergency personnel will be first in line. But he has heard nothing about making sure that drivers get vaccinated soon not from his union, from the citys Department of Transportation or from city leaders, he said.
Were basically second-class citizens, Mr. Brown, 55, said.
The arrival of a vaccine is also nurturing talk of a return to normalcy, or something resembling it. Tani G. Cantil-Sakauye, Californias chief justice, said she was imagining how the vaccine could change things for the nations largest court system, which is grappling with a huge backlog as many crucial proceedings are pushed online.
If you envision the Supreme Court, every door is open, people are in the hall leaning against doorjambs, talking, chatting, laughing, Chief Justice Cantil-Sakauye told reporters on a Zoom call this week. Thats now completely absent, and the place is silent.
She and her colleagues have debated whether judges and other court officers should be given priority for a vaccine. No one, after all, would deny that the courts were an essential function of society.
But Chief Justice Cantil-Sakauye said she ultimately came to believe that judges could not stand on title and be vaccinated before emergency workers and nursing home residents.
We think that others need to go first, she said.
Bryan Diaz, 15, of Nuevo, Calif., is also yearning for normalcy. Distance learning has been difficult with his 7-year-old brother, Kevin, vying for his attention, and he misses playing video games and kicking a soccer ball with a friend he has not seen since early in the year.
Pennsylvania, New Jersey, and Delaware officials have said they anticipate receiving vaccine doses by mid- to late December. Philadelphia, with a population of 1.5 million, will receive just tens of thousands of doses at first. Most people, including those with high-risk conditions, should not expect to be vaccinated this year, Farley said.
Health care workers could potentially receive the first shots the vaccine as early as next week.
PORTLAND, Ore Legacy Health in Portland expects to get a shipment of the Pfizer COVID-19 vaccine sometime this weekend, Dec. 12-13, with the possibility of administering the first injections by next Wednesday.
A super cold freezer inside a Legacy building will hold 2,000 doses of the vaccine.
Dr. Dominic Chan, a pharmacist by training, is in charge of the vaccine rollout for the Legacy Health system. He said the vials at will be kept at minus 75-degrees Celsius, which is minus 103-degrees Fahrenheit.
Weve gotten a shipment confirmation, so we are watching those shipment tracking with pretty baited breath and excitement, Dr. Chan said.
You can see the entire interview with Dr. Chan here.
The first vaccines will be for health care workers. But with 13,000 people who work for Legacy Health, deciding who will get the first 2,000 doses is not an easy task.
Dr. Chan said the philosophy is guided by equity, not titles.
"The hospitals cant operate if we dont have the individuals that are keeping the hygiene between patients within a room our environmental services people," he said. "Our patients need to eat, so our dietary food services have to be prioritized as well. Our lab services. The people that go and admit these patients and counsel these patients, bring the coffee up. They are just as equal in importance as our physicians and nurses, so its a very -- I just want to say its a high priority for us to establish equity in our approach to who we vaccinate.
After FDA approval, another federal group of doctors will review the Pfizer vaccine and so will a group of doctors in the western states. It should all happen very quickly and may be completed by the end of the weekend.
Dr. Chan stressed that Legacy will not rush to get the first doses out. He wants to make sure its done right.
We are going to give ourselves a couple days to read the documents and read to the very syllable and sentence of all the final recommendations," he said, "just to make sure all the operations that we have been standing up will be aligned and we wont be caught flat-footed with one small one-degree pivot that the regulatory bodies have stated. So, probably days. Days not weeks. Couple, few days after, Dr. Chan said.
He said that "Wednesday through Tuesday" is a likely timeframe for the rollout to begin.
Kaiser Permanente expects to get 1,000 doses of the vaccine and could begin injections as soon as Friday, Dec. 18.
A spokesman for Providence Health systems also expects a shipment very soon, although the exact amount is not clear. That system is preparing to give shots to its frontline workers as soon as next week.
State officials at the Oregon Health Authority said the state expects a total of 35,000 doses will be delivered by Dec. 15, with 10,725 being sent to pharmacies that will administer the injections at skilled nursing facilities.
Because all 35,000 doses will be the Pfizer vaccine, which needs to be stored at minus 70-degrees Celsius, they will be delivered along the I-5 corridor, where hospitals and universities have freezers that can safely store the vaccine.
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