The largest Alaska outbreak of the coronavirus pandemic so far is unfolding right now, within the walls of a prison in the Mat-Su Borough. At Goose Creek Correctional Center, 708 inmates had active coronavirus infections as of Monday.
Other jails face worsening outbreaks, too: 112 inmates at the Anchorage Correctional Complex and 68 in Yukon-Kuskokwim Correctional Center have the virus. Statewide, 19 incarcerated people have been hospitalized during the pandemic. Three have died.
With a limited supply of vaccines now arriving, a debate over when incarcerated people should receive the vaccine is playing out across the country -- and in Alaska. The question: Should prisoners be seen as a vulnerable population living in a congregate setting and given priority access to the vaccine?
In November, the American Medical Association called for people in jails and prisons to be prioritized for vaccination. Prisoners are at high-risk of contracting COVID-19 because the disease has spread so quickly in densely populated facilities, with devastating effects. At least 249,883 prisoners have been infected and 1,657 have died of COVID-19 in U.S. correctional facilities, according to The Marshall Project.
Being incarcerated or detained should not be synonymous with being left totally vulnerable to COVID-19, the medical association said.
Some states, such as Massachusetts, have made prisoners among the first to receive vaccines, prioritizing them alongside other people living in congregate settings, such as homeless shelters.
Groups such as the ACLU of Alaska have taken the position that prisoners should be prioritized for vaccines because they live in congregate settings with limited medical resources.
In the most favorable of circumstances, our prisons have a hard time maintaining health and sanitation standards, said Megan Edge, a spokeswoman for the ACLU of Alaska. Its a breeding ground.
According to the advocacy group Prison Policy Initiative, Alaska is one of 10 states where vaccination rollout plans are so far silent on when incarcerated people will be offered vaccines. Alaska hasnt made a decision yet about where incarcerated people will fall on the vaccine rollout plan, said Sarah Gallagher, a spokeswoman for the Department of Corrections.
This has not yet been determined, Gallagher said.
The idea of prioritizing prisoners while limited vaccine supplies exist has been politically unpalatable to some leaders nationally. In Colorado, Gov. Jared Polis told reporters that inmates shouldnt receive priority for vaccines.
Theres no way (the vaccine is) going to go to prisoners before it goes to people who havent committed any crime. Thats obvious, he said.
(A substantial proportion of incarcerated Alaskans are detained pre-trial, meaning they have been charged with a crime but not yet convicted.)
Gov. Mike Dunleavy did not respond to a request for comment about vaccination prioritization.
While the states plan isnt finalized yet, correctional officers and prison medical staff are considered first responders and will be prioritized with other first responders around the state, Gallagher said. As of Dec. 9, some 149 people who work in correctional facilities across the state have tested positive for COVID-19. That includes correctional officers as well as other workers.
And some of medically compromised prisoners living in hospital-level medical housing units will also get first crack at the vaccine. Staff and residents of prison medical infirmaries, along with front-line health care workers, emergency responders and long-term care resident facilities and staff will be among the first Alaskans to be offered vaccination, the Department of Health and Social Services said Monday.
People in infirmary and high risk people within the prison system are considered the equivalent to long term care facility as well as the staff who treat them, said state chief medical Dr. Anne Zink in a media call Monday.
Mark Carr is a regional ethicist for Providence Health & Services Alaska, and a member of a statewide task force making decisions about which populations will be given access to limited coronavirus vaccine supply, in which order.
The committee is very robust, its broad minded, its well represented, with persons and agencies all across the state, Carr said.
Public health is guided by a philosophy that makes decisions based on a utilitarian analysis, he said: Where the vaccine has the potential to make the biggest positive impact. Thats why essential health workers, crucial to the entire system of providing medical care, are first in line.
In response to a pandemic, (public health experts) are going to focus attention on instrumental value of persons in the society it has nothing to say about the moral value of a person, but whether or not a person is essential to the functioning of society, Carr said.
Vaccine allocation decisions have to be neutral, objective and data driven, by science, he said. On the other hand, deciding who gets a lifesaving vaccine first is an inherently political venture. Its not as if you can take the human out of it.
Theres several ways to analyze the question of when prisoners should be vaccinated, Carr said, speaking in general as a medical ethicist and not specifically about Alaskas plans.
In one version of that theoretical calculus, people in prisons arent essential workers in any way, and therefore should be lower priority. In that argument, those people, as dignified and valuable as we may want to assert they are, are not instrumental to the functioning of our society and therefore should fall in a lower tier of the rollout of the vaccine, he said. They are not going to keep food being delivered to grocery stores, planes in the air, fuel in vehicles, and so on and so forth.
Another approach could revolve around the notion that prisoners live in a dense congregate housing and should be prioritized as should people living in other dense housing say, the Begich Towers in Whittier, Carr said. In that analysis, you get a lot of bang for your buck by vaccinating people in big facilities, because vaccinating people could prevent a lot of disease spread.
Both approaches are focused on the consequences for our actions. A duty perspective might focus on vulnerability -- in the United Kingdom, the government is highlighting giving vaccine to the oldest among us, as a duty to protect, he said.
Carr declined to talk about the specifics of what the committee is discussing. But how to deal with incarcerated people is a topic of conversation.
We would be negligent not to, he said.
No matter where prisoners fall on the priority spectrum, DOC officials will face additional challenges in stemming outbreaks within facilities. Logistical complications to vaccinating in prisons could include the transiency of inmates, who cycle through jails and prisons for highly variable timeframes -- an extra big problem with a two-dose immunization. And theres also the question of whether inmates will choose to take a vaccine, if offered by their jailers.
1 in 5 in San Bernardino County had positive coronavirus tests after Thanksgiving San Bernardino County Sun
The care home committed an "error in judgment" in allowing the visit, the municipality of Mol in the Flanders region said in a statement Saturday.
"In-depth scientific research" would be needed to definitively say whether the visit was the cause of an outbreak at the Hemelrijck care home, the municipality said, adding that 61 residents and 14 staff members have tested positive so far.
One resident who was already receiving palliative care has died, and another resident with severe symptoms is being given oxygen therapy inside the care home, the municipality said. The "vast majority" of those infected are doing well and not showing symptoms, it added.
The man who played Sinterklaas, who is the son of a resident, tested positive for coronavirus after his visit.
He "was not feeling sick at the time of the visit" and "the activity was not cleared beforehand with the crisis center, otherwise negative advice would have been given," the municipality said.
CNN has reached out to the care home's operator, Armonea, for comment.
"Contrary to reports in the media, St. Nicholas did not visit every room. The management reassures us that the saint only visited common areas, including the seating areas," the municipality said.
"The saint maintained distance at all times from the residents, and didn't remain in any area longer than a few minutes. The saint did not hand out presents."
Belgium has been hit hard by the pandemic. The nation of 11.5 million has recorded 608,137 coronavirus cases and 17.951 deaths, according to data from Johns Hopkins University.
At the end of October, pressure on the health service was so great that health workers in some hospitals in Lige, Belgium's third largest city, were asked to continue working even if they tested positive for Covid-19 -- as long as they were not showing any symptoms of the disease.
1. How COVID-19 is affecting the globe
Confirmed cases of COVID-19 have now passed 72.8 million globally, according to the Johns Hopkins Coronavirus Resource Center. The number of confirmed deaths stands at more than 1.62 million.
Japan's economy won't return to pre-pandemic levels until at least early 2022, according to a Reuters poll of economists.
Jet fuel market profits have increased, thanks to increasing air cargo demand, gradually recovering passenger traffic and hopes that a COVID-19 vaccine will boost international travel next year.
A cautious takeoff?
Image: Reuters
Airlines are being warned to take extra care when reactivating planes left in extended storage as a result of the pandemic - with pilot rustiness, maintenance errors and even insect nests all cause for concern.
Moderna has said that some documents, related to pre-submission talks of its COVID-19 vaccine, were accessed in a cyberattack on the European Medicines Agency.
Sweden was close to an all-time high yesterday for the number of COVID-19 patients being treated in hospital.
Spain expects to start vaccinating people against the coronavirus by 4 or 5 of January, if the European Medicines Agency (EMA) gives the green light to a vaccine on 29 December, health minister Salvador Illa said on Monday.
Czech restaurants, hotels and indoor sports venues will close again on Friday, just two weeks after reopening. The measures have been taken as a result of rising cases.
The UK's capital, London, and some surrounding parts of the southeast of England will be put under stricter COVID-19 restrictions from Wednesday.
Announcing the new restrictions, Health Secretary Matt Hancock also said over 1,000 cases of a new coronavirus variant had been identified in the past few days in England. He said it was growing faster than the existing variants, but was "highly unlikely" it wouldn't respond to a vaccine.
In 2000, Gavi, the Vaccine Alliance was launched at the World Economic Forum's Annual Meeting in Davos, with an initial pledge of $750 million from the Bill and Melinda Gates Foundation.
The aim of Gavi is to make vaccines more accessible and affordable for all - wherever people live in the world.
Along with saving an estimated 10 million lives worldwide in less than 20 years,through the vaccination of nearly 700 million children, - Gavi has most recently ensured a life-saving vaccine for Ebola.
At Davos 2016, we announced Gavi's partnership with Merck to make the life-saving Ebola vaccine a reality.
The Ebola vaccine is the result of years of energy and commitment from Merck; the generosity of Canadas federal government; leadership by WHO; strong support to test the vaccine from both NGOs such as MSF and the countries affected by the West Africa outbreak; and the rapid response and dedication of the DRC Minister of Health. Without these efforts, it is unlikely this vaccine would be available for several years, if at all.
Read more about the Vaccine Alliance, and how you can contribute to the improvement of access to vaccines globally - in our Impact Story.
2. US and Canada begin inoculations
An intensive care unit nurse in New York City yesterday became the first person in the United States to receive a COVID-19 vaccine.
It didnt feel any different from taking any other vaccine, Sandra Lindsay said. I feel hopeful today, relieved. I feel like healing is coming. I hope this marks the beginning of the end of a very painful time in our history."
It comes as the virus's death toll in the United States passed 300,000 - nearly 120,000 more than any other country in the world.
US deaths have passed 300,000.
Image: Our World in Data
Canada also began its innoculation programme yesterday. Frontline healthcare workers and elderly nursing home residents were among the first to receive the jab.
3. Netherlands to enter new lockdown
Dutch Prime Minister, Mark Rutte, has announced that the Netherlands will go into a second lockdown. Schools and shops will close until 19 January.
The Netherlands is closing down, he said to the sound of protesters banging pots and pans outside his office in The Hague. We realise the gravity of our decisions, right before Christmas.
Gatherings are also limited to no more than two people. An exception will be made for three days across the Christmas period, when three adult visitors will be permitted.
Residents were advised to stay at home, not to travel to work and to avoid contact with other people as much as possible.
The less contacts we have, the better. We have to do everything to get to a better place. And yes, it will get better.
The unprecedented effort to identify one or more safe and effective vaccines for COVID-19 includes more than 180 candidates in development (1), with at least 12 in phase 3 trials (2). The testing of so many vaccine candidates, in a pandemic of a disease for which there are to date limited treatment options, raises a critical challenge: What should researchers do if a vaccine candidate is judged to be safe and efficacious? Guidance from the U.S. Food and Drug Administration (FDA) states that in the event that a COVID-19 vaccine candidate is judged to be safe and effective, discussion may be necessary to address ethical arguments to break the blind and offer vaccine to placebo recipients (3). We consider here two questions raised by this guidance: First, if a vaccine candidate is found to be safe and efficacious in a placebo-controlled trial, should the researchers continue that trial as designed? Second, should researchers continue to test other vaccine candidates using placebo-controlled trials? These two questions are especially timely given recent announcements by Pfizer and Moderna that their vaccine candidates have been found to be efficacious in preventing symptomatic COVID-19 (4, 5).
A finding of efficacy occurs when a vaccine candidate being tested in a phase 3 trial meets its efficacy end point, either during an interim analysis or after study completion. The primary efficacy end point of current phase 3 trials is whether the vaccine candidate prevents symptomatic COVID-19 in individuals newly infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (6). A finding of efficacy in these trials thus implies that the vaccine candidate protects infected individuals from experiencing symptoms. A finding of safety occurs when there is sufficient data on the impact of the vaccine candidate to conclude that its potential benefits justify its risks in the target population.
A single finding of safety and efficacy may not be sufficient for a vaccine candidate to receive FDA approval. Depending on the strength of the data, it may be important to conduct additional research to learn more about the vaccine candidate and gain greater confidence in its safety and efficacy before offering it to millions of people. For example, the FDA frequently requires a finding of efficacy in two phase 3 trials before approving medical interventions for marketing to the public.
Still, a finding of safety and efficacy in a phase 3 trial is an ethically critical point in the vaccine development process. From that point, receiving the vaccine candidate is known to offer protection to many individuals. Hence, receiving a placebo instead is contrary to their interests, even though it may be necessary to collecting socially valuable data.
This tension between protecting research participants and gathering data that may benefit others is common to clinical research, and there is substantial literature on how to address it (7). Although this literature applies to the ethics of vaccine trials, the present situation is unparalleled.
There is a global crisis for which there are currently limited treatment options. Hence, billions of individuals could benefit from a safe and efficacious vaccine. And having so many vaccine candidates in development substantially increases the chances that one or more will be found to be safe and efficacious while others are still being tested. Limitations on current treatment options mean that it is in each individual's interests to receive the first vaccine found to be safe and efficacious, rather than participate in vaccine trials where they might receive placebo or an unproven vaccine candidate.
In addition, given the challenges of manufacturing sufficient supply for so many people, and given that different vaccine candidates may be efficacious in different populations, several vaccines may be needed to meet the global need. This highlights the potential social value of conducting additional trials after one or more vaccine candidates are found to be safe and efficacious.
Moreover, vaccine candidates typically have not been widely available until after they receive marketing approval by the FDA. However, the FDA has indicated that it may take the unprecedented step of making a vaccine candidate that is found to be safe and efficacious widely available through an emergency use authorization (EUA) before marketing approval. An EUA involves the FDA commissioner allowing unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives (8).
Pfizer recently announced that at the first interim analysis, its vaccine candidate was found to be 95% effective at preventing symptomatic COVID-19 (4, 5). A week later, Moderna announced that its vaccine candidate was found to be 94.5% effective. At that point, the trials had enrolled more than 43,000 and 30,000 participants, respectively, of whom 94 and 95 developed symptomatic disease. If these findings are confirmed, they will represent an important public health advance, and provision of the vaccine candidates would be in the interests of many individuals. The FDA may thus grant an EUA, making either or both vaccines available before each study's completion and also before FDA marketing approval.
Some commentators argue that clinical trials are ethically acceptable only as long as there is insufficient evidence that the intervention offered in one arm is superior to what is offered in another arm, or to what is available outside the trial (9). This view implies that it would be unethical to continue Pfizer's and Moderna's placebo-controlled trials given the findings of efficacy. It also implies it would be unethical to test other unproven vaccine candidates against placebo.
Proponents defend this view on the grounds that it provides a way to protect participants from excessive risks. They argue further that researchers conducting clinical trials are obligated to treat participants consistent with their clinical interests and conclude that it is unethical to give participants a placebo once a safe and efficacious vaccine has been identified.
We disagree. This view fails to recognize that the obligations researchers have to their participants are distinct from the obligations that clinicians have to their patients (9). It further ignores the existence of other mechanisms, including independent review and informed consent, to protect research participants from excessive risks. The differences between the ethics of clinical research and clinical care are reflected in the consensus that it can be ethically appropriate to invite research participants to accept some risks to collect socially valuable data. In particular, codes and guidelines around the world permit researchers to expose participants in clinical trials, including vaccine trials, to some risks to collect socially valuable data that cannot be obtained in a less risky way (10).
These guidelines have a critical implication for COVID-19 vaccine trial ethics: Researchers are not obligated to provide placebo recipients with a safe and efficacious vaccine once one has been identified. Instead, researchers are obligated to ensure that any plans to conduct placebo-controlled trials remain ethically appropriate given current evidence. Such plans must be reviewed and approved by an independent board, known as an institutional review board (IRB) in the United States, which must find that a number of conditions are satisfied (11). Two of these conditions are particularly important for determining the acceptability of conducting placebo-controlled trials after a vaccine candidate has been found to be safe and efficacious: Is the trial's risk-benefit profile still acceptable? Do participants consent?
Continuing a blinded, placebo-controlled trial after the vaccine candidate being tested has been found to be safe and efficacious is justified only when the trial's risk-benefit profile remains acceptable. Making this determination requires answering three questions: (i) What is the social value of continuing the trial? (ii) What are the risks to participants of continuing the trial? (iii) Are the risks to participants sufficiently low and justified by the social value of continuing the trial?
Continuing a trial after the vaccine candidate has been found to be safe and efficacious can provide an opportunity to collect several types of socially valuable data. Of greatest importance, it can provide greater confidence in and a more precise point estimate of the vaccine's efficacy and offer an opportunity to collect additional safety data, including data on any uncommon or delayed side effects. It can also help to assess how long the vaccine's protective effect lasts; offer insight into the vaccine's impact in various subgroups, such as older individuals or those with comorbidities; and evaluate whether the vaccine candidate protects against infection itself.
Once a vaccine candidate is found to be efficacious, participants in the placebo arm are known to be at higher risk of symptomatic disease than those in the active arm. The degree of risk depends on the chances that participants in the placebo arm will become infected, the risks they face if they are, and how much protection the vaccine candidate offers.
A volunteer receives an injection as part of a phase 3 trial of the vaccine candidate developed by Pfizer and BioNTech.
The chances that participants in the placebo arm will be infected depends on the local transmission rate, preventive measures they adopt, and the amount of time they remain on placebo. When participants are on placebo for a short time, the chances of infection are correspondingly low. For example, Moderna plans to continue its placebo-controlled trial until 151 cases of symptomatic disease are identified (5). Given current transmission rates, this may take as little as a few weeks.
Remaining on placebo for a few weeks, rather than accessing an efficacious vaccine, poses a low chance of substantial harm. Continuing on placebo for even longer periods also poses a low chance of substantial harm to individuals at low risk for severe disease.
Remaining on placebo for an extended period can pose considerable risks to individuals at high risk of severe disease. The extent of these risks depends critically on what options are available to them. In the setting of few effective treatments and potentially strained hospital systems, receiving placebo for an extended period rather than a safe and efficacious vaccine can pose substantial risks. However, if high-risk individuals would not have access to a safe and efficacious vaccine outside of researchfor example, there is only enough supply for the trial or they are not part of a prioritized group that will receive the vaccine during the time of the trialreceiving placebo in a clinical trial poses few additional risks to them.
There is no algorithm for determining how much social value a given clinical trial has and whether its social value justifies the risks participants face. As a result, IRBs tend to focus on ensuring that a trial has the potential to collect important data and that the risks of substantial harm are low.
Trials with the potential to collect data helpful for addressing a global pandemic have considerable social value. Inviting competent adults to participate in such trials can be ethical when doing so poses a small increase in their risk of experiencing substantial harm. This suggests that it can be ethically acceptable to continue a placebo-controlled trial for a short period after the vaccine candidate has been found to be safe and efficacious, even when participants might be able to access the vaccine candidate outside the trial, for example, through an EUA (12). By contrast, if continuing the trial does not offer the opportunity to collect socially valuable data, or comparable data can be obtained in less risky ways, continuing the trial with a placebo arm for any length of time would be ethically problematic.
Inviting participants who are at low risk of severe disease to remain blinded and stay in the trial for a longer period can be acceptable when it offers the potential to collect data that might be helpful for addressing the pandemic. In most cases, continuing a blinded, placebo-controlled design with high-risk individuals for longer periods will not yield data of sufficient value to justify it. Exceptions might include when the individuals cannot access an efficacious vaccine outside the trial and their participation is needed to collect valuable data, or they are in a group for whom no efficacious vaccine candidate has been identified. Otherwise, individuals at high risk of severe disease should be unblinded and those on the placebo arm offered the vaccine within a redesigned study or given the opportunity to seek the vaccine outside the trial.
When the value of the data to be collected does not justify the risks of continuing the trial as designed, researchers have several options. They can unblind participants; offer placebo recipients the vaccine, possibly as part of an expanded access program; and follow them to collect additional data (13). Alternatively, researchers might redesign the trial, for example, to include a crossover in which the blind is maintained and those on the placebo arm receive the vaccine after they complete the placebo arm. Finally, in some cases, it may make sense to simply stop the trial and unblind participants, thus allowing those in the placebo arm to seek the vaccine elsewhere.
Even when a vaccine candidate is found to be safe and efficacious, there are likely to be good reasons to study others. Another vaccine candidate might be more effective, generate longer-lasting immunity, work better in certain subpopulations, provide greater protection against severe disease, or prevent infection better. Other candidates may also be superior with respect to cost or other practical considerations. For example, Pfizer's vaccine candidate must be stored at very low temperatures until 5 days before administration, a requirement which will reduce its availability in many parts of the world.
When there are safe and effective interventions available, the default is to use them rather than placebo as the comparator in clinical trials. Thus, if the Pfizer or Moderna vaccine candidates, or others, are confirmed to be safe and efficacious, researchers should consider whether their trials can be redesigned as a comparison between the vaccine candidate they are testing and a safe and efficacious vaccine. When making this decision, researchers and IRBs should take into account that an active comparison trial is likely to require larger sample sizes and extend the duration of the trial.
Redesigning ongoing trials to include an efficacious vaccine as an active comparator may not always be feasible or valuable. If continuing to evaluate the vaccine candidate nonetheless offers important social value, participants at low risk of severe disease might be invited to stay blinded and remain in the placebo-controlled trial. If continued participation appreciably increases participants' risk of severe disease, researchers should discuss participants' options for obtaining an efficacious vaccine outside research.
Researchers are ethically obligated to inform participants of developments that might influence their willingness to remain in a clinical trial. Clearly, that a vaccine candidate has been found to be safe and efficacious meets this standard. Hence, investigators should inform participants in all trials of such a finding. This information should include the vaccine's safety record, the level of protection it provides, the populations for which it has been found to be safe and efficacious, and whether it might be available through an EUA or other means.
Researchers should then explain the plans for their trial going forward and solicit participants' consent. To minimize potential confusion and distrust (14), participants should understand the rationale behind the plan and that their prior consent does not obligate them to continue to participate. If researchers intend to continue with a placebo-controlled design, participants can be encouraged to remain in the trial. However, once a safe and efficacious vaccine candidate is available, knowing whether they received placebo or vaccine becomes relevant to a participant's decision whether to seek the vaccine outside research. Hence, participants who choose to leave the trial should be informed whether they received the vaccine candidate or placebo.
If one or more efficacious vaccines become widely available outside research, continuing a blinded, placebo-controlled trial might result in participants in both the active and placebo arms dropping out and seeking the vaccine elsewhere. Researchers should anticipate this possibility and consider whether they might unblind participants, offer an efficacious vaccine to the placebo recipients, and follow everyone. Alternatively, it might make sense to continue the blinded, placebo-controlled trial with a guarantee that individuals in the placebo arm will receive an efficacious vaccine once their participation in the study is completed. With careful planning and systematic assessment of the social value and risks, we believe it can be ethical to conduct some placebo-controlled trials of vaccine candidates for COVID-19 even after we have an efficacious vaccine. Doing so may be necessary to effectively address a pandemic that is causing so much harm around the world.
Acknowledgments: Thanks to E. Erbelding for valuable discussion of this issue. This work was funded by the Intramural Research Program at the U.S. National Institutes of Health Clinical Center. The authors declare no competing interests. Disclaimer: The opinions expressed are the authors' own. They do not represent the position or policy of the National Institutes of Health, the U.S. Public Health Service, or the U.S. Department of Health and Human Services.
Update: The Department of Veterans Affairs released a preliminary COVID-19 vaccine distribution plan Thursday morning on Dec. 10, 2020. The plan lists the 37 VA sites that will administer the Pfizer vaccine once it receives approval from the Food and Drug Administration. The list can be found here.
The Department of Veterans Affairs is preparing to distribute a COVID-19 vaccine as soon as its approved, but the agency acknowledged Wednesday it may initially struggle to reach healthcare workers and veterans in remote and rural locations.
VA so far has ordered 73,000 doses of the Pfizer vaccine and another 122,000 doses from Moderna, said Richard Stone, the departments acting undersecretary for health. Both COVID-19 vaccines require two shots per person.
The Pfizer vaccine, which is currently under review at the Food and Drug Administration, may receive emergency-use authorization by the end of the week.
Once it does receive authorization, VA is expecting a shipment of Pfizer doses nationwide, possibly as soon as this weekend, Stone said.
Can you handle the distribution, and then is that an adequate amount for the largest healthcare system in the nation? Jon Tester (D-Mont.), ranking member of the Senate Veterans Affairs Committee, said Wednesday at a hearing on VAs COVID-19 response.
It is not an adequate amount, and this will be a long process for us to reach all 7 million veterans who we believe will want vaccination from us, as well as all 400,000 employees of the agency, Stone told the committee. We do anticipate weekly distribution, and it remains to be seen how robust that weekly distribution will be.
VA hasnt yet released a comprehensive COVID-19 vaccine distribution plan, but it has offered a few details in a series of frequently-asked-questions for veterans posted on its website. VA health care employees at highest risk of contracting COVID-19 will receive the vaccine first.
Committee members are especially interested in VAs distribution plan, with some expressing some concern that the department hadnt released one publicly.
The Pentagon on Wednesday described its plans under a pilot program to distribute an initial 44,000 doses to 16 military sites, where mostly defense health workers will be first line to receive them.
Our vaccine plan is with the CDC, Stone said. That vaccine plan is still dependent on our ability to move the Pfizer vaccine, which requires a -70 degrees Fahrenheit refrigeration and freezing, across the nation.
As of Wednesday, 37 VA sites were equipped with the proper freezers needed to support the Pfizer vaccine. Stone said hes expecting a shipment of another 36 freezers, meaning VA may eventually have a total of 73 sites that are equipped to receive an initial shipment of Pfizer vaccines, once its approved.
We do anticipate that shipment will occur across the nation, and then it will depend upon on whether we can secondarily ship that -70 degree vaccine further, Stone said of the Pfizer doses. That decision has not been made by CDC, which is why you havent seen our really robust vaccine distribution plan.
The department also has 188 sites that can accept the Moderna vaccine once its approved, Stone added.
All VA medical centers have completed simulation exercises, where theyve walked through how they might distribute, receive and then administer the COVID-19 vaccine. The department does have some practice in distributing and administering new vaccinations, Stone reminded senators.
VA has annual influenza inoculation program, and its administered 1 million flu shots to veterans so far this year.
Still, Stone said hes especially concerned about VAs ability to deliver the COVID-19 vaccine to rural and remote locations. The 73 sites VA anticipates it will have to administer an approved vaccine from Pfizer arent nearly enough, and Stone said the department will have to rely on the Moderna supply to reach more remote facilities.
This morning I had a conversation about our ability to obtain short-runway aircraft to go into rural areas, where we could bring small amounts of vaccine into those rural areas where theres 20, 30, 50 or 100 veterans, Stone said. I believe were going to need to have that kind of creativity and innovation in order to deliver this effectively.
Like the rest of the country, VA is experiencing a surge in active COVID-19 cases, though Stone said the department had beds and spots within its intensive-care units open and available for veterans and members of the public.
VA on Wednesday was tracking 16,449 active cases, including 1,300 employees. A total of 77 employees within the Veterans Health Administration have died from complications due to COVID-19 since the start of the pandemic, according to the departments public data.
To respond to the pandemic, VHA received $17.4 billion through the Coronavirus Aid, Relief and Economic Security (CARES Act) back in March. VAs health administration has spent about $8 billion of that so far, but Stone said he anticipates needing more resources.
Well consume the rest of that through the rest of this fiscal year, but I do believe that theres a lot we cant see about vaccine distribution, he said. I think were still probably three-to-four weeks ahead of the peak of what were going to see in this escalation of cases across the nation.
Beyond the additional funding, VA is hopeful Congress will also extend additional authorities that helped the department more quickly hire new health professionals.
Stone described the hiring waivers VA received from the Office of Personnel Management as absolutely critical in helping the department bring on more than 66,000 new employees since the pandemic began.
Should we expire in those authorities, it will make it very difficult for us to sustain this workforce in the manner that we have, he said.
PHOENIX (3TV/CBS 5) -- The first doses of the Pfizer vaccine are expected to arrive in Arizona between Monday, Dec. 14 and Wednesday, Dec. 16. The first doses of the Moderna vaccine, once approved, should arrive the week of Dec. 21.
Arizona is expected to get 384,350 doses of the vaccine, but not all at once, and only the first dose. The second doses will arrive later.
Dr. Cara Christ, Director of the Arizona Department of Health Services (AZDHS), said the planned turnaround times from the doses arriving in Arizona to patients given the vaccine would be 24-48 hours.
A: While there have been a couple of cases in Britain in which patients had an allergic reaction to the vaccine, Pfizer, the manufacturer, says it appears to be safe.
Dr. Christ said when people get the vaccine, they will need to stay put with their provider for about 15 minutes to make sure they do not have an adverse reaction.
Neither Pfizer nor Moderna reported any serious side effects during their clinical trials. The most common side effects, according to the manufactures, are not unusual with vaccines.
"We need to let everybody know that the vaccine is safe, effective, and it's for everyone's benefit," Dr. Christ said.
There are several things, however, that cannot be known yet, including what, if any, long-term effects the vaccine might have.
It's also not clear if the vaccine can prevent transmission of the coronavirus that causes COVID-19 or if it only prevents people from getting sick.
An expert committee endorsed the Pfizer vaccine on Thursday. Dec. 11. The Food and Drug Administration was expected to quickly green-light the vaccine for emergency use based on the panel's recommendations.
The FDA is scheduled to look at the Moderna vaccine on Dec. 17.
A: Two. The second dose comes 21 or 28 days after the first.
A: Not fully.
"While some protection will be obtained two weeks after the first dose, full protection will not be achieved until one to two weeks after the second dose," Dr. Christ said. "That second dose is very important."
A: There's no certain answer to that yet, but medical experts seem to be leaning toward an annual shot like the flu vaccine. Viruses mutate over time and vaccines have be adjusted to be as effective as possible against current strains. It's probably not a one-vaccine-fixes-everything-forever approach. Medical researchers are still learning about the body's responses to the coronavirus and how the antibodies to it work. There's still quite a bit that's unknown.
A: The short answer is possibly.
If you have an underlying medical condition, you might be exempt under the Americans with Disabilities Act. Title VII of the Civil Rights Act provides similar protection for people with "sincerely held" religious believes against vaccines.
If you are exempt, you and your employer would need to work together to come up with "reasonable accommodations." What that looks like varies. It could be remote work or it could be using personal protective equipment (PPE) at the workplace.
Absent those two exceptions, you will be taking a risk against your employer's mandate. Employers have the right to enforce their requirements.
"If your employer requires it, and you don't do it, then it is likely you'll lose your job," said attorney Logan Elia with Rose Law Group.
A: The vaccine is being rolled out in phases before it becomes available to the general population.
A: It depends. The first doses will go to frontline workers, essential workers, and people at high risk for developing complications from COVID-19. The vaccine will likely not be available to the general public until spring of 2021.
The Maricopa County Health Department created a COVID-19 Vaccine Prescreen for health care workers and others in Phase1A to register. To learn more, click here.
The New York Times created a tool to help people determine their "place in line" to get the vaccine. It looks at at four specific factors -- your age, where you live, your profession, and underlying conditions. This is not a reservation or registration for the vaccine. It's merely meant to give you and idea where you might fall in what's going to be a massive vaccination effort.
A: Nothing is certain except death and taxes, but Pfizer says its vaccine is 95% percent effective at preventing COVID-19. Moderna puts its vaccine's efficacy at 94.5%.
If you do develop the disease, you probably will not get as sick as you might have otherwise.
A: "There are no clinical trials yet conducted in children or pregnant women," Dr. Christ said. "As we get more information, will be adding more information about kids and pregnant women."
A: Medical experts say yes. While Pfizer says its vaccine is effective at preventing people from getting COVID-19, it's not clear yet if it has any effect on transmitting the virus. So, even if you do not get sick, you could still be contagious.
"It will be important for everyone to continue taking precautions, even after being vaccinated, to ensure that we are protecting our loved ones and those around us," according to Dr. Christ.
Medical experts worldwide have made it clear that masks are not just to protect the wearer but also to protect everyone around them.
A: It's free.
A: No
After Shirley Flores, a postmaster and mother of three, died in Las Cruces, N.M., her family noted in her obituary: She died a very painful lonely death because we werent allowed in to hold her hand and sit with her. Please take Covid-19 seriously, protect yourself and those you love.
The obituary of Shirley Rowe, a 67-year-old Michigan resident, said that she had fought for her life after contracting the virus, but her body was overpowered by Covid-19. Ms. Rowe was a loving grandmother and the life of every party, her family said, and believed she caught the coronavirus from a guest at her home.
It is our familys firm belief that she would still be here if restrictions hadnt been lifted so soon for society, and the person that gave her the virus would have taken precautions more seriously, they wrote. This is not how my moms story should have ended.
Judy Fuller, 76, of Blue Grass, Iowa, died from the coronavirus in September, after she and her husband, Ron, fell ill at the same time. Ms. Fuller was known for her bright smile, her love of fashion and the outdoors, and her devotion to her job handling staffing at the hospital, where she worked for nearly four decades.
In lieu of flowers or donations, we just ask to take the Covid-19 virus seriously and please spend time with your loved ones, her family wrote. Life is short, enjoy time with your family while you can.
Mr. Fuller, who is currently nursing his son back to health after he contracted the coronavirus, said that he had wanted to send a quiet but urgent message in the obituary.
What's the point: The effort to vaccinate Americans to prevent them from getting the coronavirus will be a complicated effort. There will need to be enough vaccines, a plan to get Americans those vaccines and, finally, Americans willing to take them.
The first two parts of that equation are largely out of everyday Americans' hands.
The good news is that when it comes to the third and final crucial step, the percentage of Americans who say they'll get the vaccine continues to climb higher.
Take the Marist College poll, for example. The 61% who indicated that they'd get vaccinated is up from 49% in September. Pew's shift is in the positive direction as well going from 51% in September to 60% now.
Most promising perhaps is what Gallup is showing. The percentage of Americans said they'd agree to get the vaccine went from 50% in late September to 58% in late October to 63% in late November. In other words, we're seeing a steady, not just one time, incline.
We'll have to see how well these poll results actually capture future reality.
That's why it's so important to pay attention to the trendline. A rise in that is good news no matter what the actual baseline is.
It's possible baseline questions such as these may actually be underestimating the number of Americans who'd be willing to get vaccinated. What polls agree upon is that Americans want to see is that the vaccine works and is safe.
The Quinnipiac poll found that just 37% of registered voters said they'd get a coronavirus vaccine as soon it became available. Another 41% said they'd wait a few months. A mere 20% said they'd never take it.
In sum, 78% of voters say they'd get when given the option to wait a few months. That's higher than the 61% who said they'd get when posed a binary yes or no by Quinnipiac.
Still, there's work to be done when it comes to convincing Americans to get vaccinated. Some of the skepticism seems to be concentrated in certain groups.
There also seems to be a widening partisan gap on the vaccine. In the Gallup poll, 75% of Democrats compared to 50% of Republicans said they'd get it.
Beyond that, things don't break down so neatly. Women (54% in the Pew poll) are less likely than men (67% in the Pew poll) to say they'd definitely or probably take the vaccine, even though women are more likely to be Democrats.
We may need concentrated messages aimed at all of these groups to overcome their unwillingness to get vaccinated.
That's why the next few months will be crucial in ensuring enough Americans take the vaccine. There needs to be coordination in messaging, not just in delivering the vaccines themselves.
Eventually he was directed to an emergency room in his city, which was expecting him. He was given an infusion of the drug on Monday. He is feeling much better, he said.
Both Mr. Trump and Mr. Christie, a longtime friend of his and former New Jersey governor, got the antibodies before they were approved by the F.D.A. Dr. Caplan, the medical ethicist, said he had no problem with Mr. Trump, 74, getting the therapy he is, after all, the president, a special person unto him- or herself.
But Mr. Christies access appeared to be extraordinary. Mr. Christie, 58, was offered participation in a Regeneron clinical trial but turned it down, a person familiar with his treatment said, fearing he might receive a placebo. Instead, he received the Eli Lilly treatment. He is overweight and has asthma, and thus may have been a good candidate, Dr. Caplan said, though he wondered if similarly situated patients would have gotten the drug.
Dr. Carson, 69, got the Regeneron cocktail after it was approved, then took to Facebook last month to say he was desperately ill with the coronavirus until the president intervened.
President Trump was following my condition and cleared me for the monoclonal antibody therapy that he had previously received, which I am convinced saved my life, he wrote, adding that we must prioritize getting comparable treatments and care to everyone as soon as possible.
Mr. Giulianis treatment is less clear. Calling into ABC Radio from his hospital bed on Tuesday, he said specifically that he had received two drugs remdesivir, which has F.D.A. approval for treatment of Covid-19, and dexamethasone, a steroid.
But he also said he had received the same treatment cocktail as the president: Exactly the same, his doctor sent me here; he talked me into it, Mr. Giuliani said of Mr. Trumps physician, adding, The minute I took the cocktail yesterday, I felt 100 percent better. It works very quickly, wow.
