The U.S. Centers for Disease Control and Prevention has confirmed that it has informed public health officials in all 50 states and several large cities to be prepared to distribute a coronavirus vaccine by November 1, two days before the presidential election.
The McClatchy news service was the first to report Wednesday that the CDC had sent out a four-page memo on August 27 for health departments to draft vaccination plans by October 1to coincide with the earliest possible release of COVID-19 vaccine.
The New York Timessays the memo from Dr. Robert Redfield, the director of the CDC, was also sent to public health officials in all U.S. territories, as well as New York City, Chicago, Philadelphia, Houston and San Antonio.
The CDC memo said health care professionals, employees of long-term care facilities and other essential workers, plus national security employees, should receive initial priority for a possible new vaccine.
The Timessaid the CDC also gave priority to Americans 65 years old or older, people from racial and ethnic minority populations, Native Americans and incarcerated individuals.
Dr. Redfield also urged health officials to quickly approve permit applications from McKesson Corp., the firm that has contracted with the CDC to distribute vaccines to sites including state and local health departments and hospitals, and if necessary.consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.
Fauci's take on potential vaccine
News of the CDC memo coincided with remarks made Wednesday by Dr. Anthony Fauci, thedirector of the National Institute of Allergy and Infectious Diseases, who said that he is confident there will be a safe and effective COVID-19 vaccine by the end of the year.
However Faucialso said in an interview last week with Reuters news agency that"the one thing that you would not want to see with a vaccine is getting an[emergency approval of a vaccine]before you have a signal of efficacy."
"One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial," he said.
Otherhealth experts havealsoexpressedskepticismaboutrolling outa vaccine before the completion of clinical trials, saying hasteningits distributionto the publiccould pose safety risksanddeepen anti-vaccination sentiments.
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Safety checks
Patricia Zettler, a former Food and Drug Administration associate chief counsel told the Washington Post this week, I think its extremely critical we have rigorous evidence of safety and effectiveness supporting a vaccine before the FDA gives its okay. Zettler is currently a law professor at Ohio State University.
Somestatehealth departmentssaythey lack the staff, money and tools to educate people about vaccines and then to distribute, administer and track hundreds of millions of doses, according to the Associated Press.
There is a tremendous amount of work to be done to be prepared for this vaccination program, and it will not be complete by Nov. 1, Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition, a national vaccine education and advocacy organization in Minnesota, told the AP. States will need more financial resources than they have now.
Only half of Americans trust vaccine
A recent poll from AP-NOR Center for Public Affairs Research found that only about half of Americans said they would get vaccinated.
The United States leads the world with 6.1 million total COVID-19 cases and 863,445 deaths. A surge of new cases across the countryis attributed tocollege students taking part in large off-campus parties as they return toschoolfor the start of the academic year, ignoring guidelines to wear face masks and observe social distancing. The latest outbreak is at the University of South Carolina in Charleston, where more than 1,000 students tested positive for COVID-19 in August, bringing the positivity rate to nearly 28 percent.
The university has placed nine fraternity and sorority houses under a 14-day quarantine after some students tested positive. The school has also suspended 15 students for throwing off-campus parties. Hundreds of students were also spotted crammed together at a large pool party off-campus that the local fire chief described as almost like Mardi Gras, a reference to the large and boisterous street celebrations held before the Christian season of Lent.
COVID death linked to South Dakota rally
Meanwhile, a resident of the northern state of Minnesota is believed to be the first person to have died of the coronavirus after attending a huge motorcycle rally in the neighboring state of South Dakota last month.
Health officials in Minnesota say the man was in his 60s and had underlying health conditions. He was one of hundreds of motorcycle enthusiasts who converged on the small town of Sturgis for 10 days, many of them also refusing to wear face masks or observe social distancing.
At least 260 new COVID-19 infections in 11 states have been tied directly to the event, according to the Washington Post.
Your body might produce antibodies to battle the novel coronavirus for four months and fade away slowly thereafter, which raises new hopes for the COVID-19 vaccine, according to a new study.
The new research published in the New England Journal of Medicine looked at more than 30,500 COVID-19 patients in Iceland.
This new research means there is hope that host immunity to this unpredictable and highly contagious virus may not be fleeting and may be similar to that elicited by most other viral infections, the researchers wrote in an editorial on the study.
Infections and vaccines generate two waves of antibodies: The first wave is generated by early short-lived plasma cells, poised to populate the systemic circulation, but this wave subsides rapidly after resolution of acute infection, wrote researchers Galit Alter and Robert Seder in the editorial.
Researchers admitted two hiccups more research needs to be done to confirm this happens. And its unclear if the antibodies really prevent reinfection or not, according to the New York Post.
Once safe and effective COVID-19 vaccines are available, tough choices will need to be made about who gets the first shots.
A committee of the National Academies of Sciences, Engineering, and Medicine at the behest of the Centers for Disease Control and Prevention and National Institutes of Health has proposed an equitable way to allocate the vaccine.
They recommend first responders and health care workers take top priority. Older adults in congregate living situations would also be part of a first vaccination phase, according to the plan.
We are faculty at Johns Hopkins University and the University of Southern California who have spent decades studying health economics and epidemiology. One of us is a member of the National Academy of Medicine.
Having seen firsthand the real risks of rapid, asymptomatic spread of COVID-19 among younger adults, we disagree with some of the recommendations. Asymptomatic spread is shutting down schools and universities nationwide and threatening surrounding communities.
We argue that this pandemic requires a different model for making vaccination choices. After taking care of essential workers, vaccinations should be given to the biggest transmitters of the virus mostly the young and only then to the most vulnerable.
The textbook vaccine model goes out the window when novel viruses emerge.
Some lessons can be drawn from the 2009 H1N1 flu epidemic, which killed an estimated 500,000 people around the world. In the U.S, President Barack Obama declared the spread a national emergency.
A vaccine was developed as early as the fall of 2009. However, only 16 million doses were initially available. The CDC was required to make some difficult decisions about allocation. Some states requested 10 times the amount they were allocated.
In the end, the CDC allocated the vaccine strictly in proportion to a states population that is, on a per capita basis. States then allocated them, often with priority to infants and the elderly, along with people at high risk.
This priority to protect the most frail has been public policy since at least the 1957-1958 influenza pandemic.
Later studies, however, have shown that a better way to protect older people was to control spread among the young, which often has meant vaccinating school-age children early.
One of the lessons from these past pandemics is that vaccinating the likely asymptomatic spreaders early can avert multiple infections with others.
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The experience of the past few months has shown how important it is to check transmission with COVID-19. A recent study found that as few as 10% of those infected lead to 80% of the infection cases. What has made it more difficult is that up to 40% of those who carry the virus, often known as superspreaders, show no symptoms at all.
Very few of the COVID-19 superspreaders are elderly. It is the younger people who have a much greater propensity to resume social lives at schools and in other venues.
Among the young are a subset of highly social people with wide circles of friends who become the most fertile ground for the spread of COVID-19. These young people also have a much lower risk of death or even severe symptoms, which also means they are more likely to infect others.
Cases have been spiking in the 15- to 25-year-old age group, another likely sign that they are propelling the spread of the virus. A recent outbreak on the University of Southern Californias fraternity row infected at least 40 people.
The American Academy of Pediatrics and the Childrens Hospital Association reports that at least 338,000 children have tested positive for the virus through July 30, with more than a quarter of that number having tested positive in just the last two weeks of that month.
More broadly, younger residents in the virus hot spot of Los Angeles County make up the majority of positive new cases. In California, young people between 18 to 34 years of age account for more than one-third of cases.
Anticipating that young people will engage in activities that spread the virus, many universities put their fall classes exclusively online. Some that decided to go in-person had to close after as little as a week on campus.
With or without a vaccine, the best strategy for older Americans, especially those with underlying medical conditions, is avoiding contact with potential carriers.
Optimally, older people will drive down deaths by staying home in large numbers, and younger people will drive down infections by getting vaccinated in even larger numbers. It all works if the vaccine is effective and enough people take it.
We predict the pressures and politics around prioritizing vaccine distribution will be intense. We argue that they key will be to take the most beneficial route, not the most obvious one. With a full-scale public health campaign behind it, that will mean prioritizing those who are driving transmission, not those who are most vulnerable.
As counterintuitive as such a strategy may appear, plenty of evidence shows this would be the right approach.
ALBANY, N.Y. (WROC) On a conference call with media Thursday morning, Gov. Andrew Cuomo said the New York State Department of Health would review any COVID-19 vaccine that is approved for use by the federal government.
The federal government has told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1. The timeline raised concern among public health experts about an October surprise a vaccine approval driven by political considerations ahead of a presidential election, rather than science.
The governor recommends that New Yorkers wait on taking any federally approved vaccine until it is reviewed by the state department of health.
The President says hes going to have a vaccine, Gov. Cuomo said. CDC is talking about a vaccine in early November. How convenient. Its going to be an Election Day miracle drug. Some people are concerned that the vaccine may wind up being hydroxychloroquine, so the State Department of Health before we recommend that New Yorkers take a vaccine, the State Department of Health will be reviewing all the protocol and research by the FDA and whatever federal authorities say its safe and effective. So, we will, before we recommend New Yorkers take any vaccine, we will have the state Department of Health review it.
The governor also announced Thursday that state-approved casinos could reopen September 9 with proper safety protocol in place.
MOSCOWIn April, as Covid-19 cases surged across Russia, President Vladimir Putin called a meeting of the countrys top scientists and health officials over video link to deliver an urgent directive: Do whatever you need to create a national vaccine as soon as possible.
Four weeks later, Alexander Gintsburg, director of the state-run Gamaleya Institute for Epidemiology and Microbiology, told state television that his researchers had developed one. They were so sure it was safe, he said, the researchers had tested it on themselves.
Governor Charlie Baker said Thursday that it is incredibly important that clinical trials of a vaccine against COVID-19 are not rushed and are run with tried and true procedures.
Bakers comments came after reports Wednesday that CDC Director Robert Redfield wrote to governors last week about the urgent need to have vaccine distribution sites running by Nov. 1. The timing immediately led to skepticism among some that the administration of Republican President Donald Trump could be rushing a vaccine, or at least the promise of one, to win political points ahead of the presidential election on Nov. 3.
This shouldnt be based on a date, said Baker, who is a Republican, during a State House news conference Thursday afternoon. It should be based on a process and a set of protocols that are pretty standard operating procedure.
Baker noted that the clinical trials associated with this vaccine typically involve 30,000 people, adding, I have no idea how long those trials are going to take. But those trials need to be able to run completely through their course.
Baker also said the big issue for him is that these be done right, and that the process gives people comfort and confidence that this thing is going to be safe and effective.
The last thing we should do . . . is change the way these processes work. I know everybody wants to get there in a hurry, and I understand why, he said. But we have a tried and true process for developing these kinds of things, and it needs to be pursued according to the rules and protocols and standards that have always been in place before.
When Baker was asked point-blank by a reporter if he thought having a vaccine by late October was rushing it, the governor replied, I dont know the answer to that, and Im not going to speak to it.
Massachusetts Secretary of Health and Human Services Marylou Sudders said that the Department of Public Health has an internal working group to make sure a reliable infrastructure is in place for vaccine distribution.
We distribute presently about 3.2 million doses of vaccine on an annual basis, so we have a well-established process for distribution of vaccines in the Commonwealth, she said. So we have a good platform and infrastructure to build from.
As for who gets priority in receiving the vaccine once its ready, Sudders said the department would also seek input from a group of people outside of government to help ensure we have an equitable lens in the distribution, adding that the federal government will also likely have requirements around prioritization.
Material from The Associated Press is included in this report.
Jaclyn Reiss can be reached at jaclyn.reiss@globe.com. Follow her on Twitter: @JaclynReiss
The presidents of Dillard and Xavier University have signed up for the COVID-19 vaccine trial and are encouraging others to do so as well.Presidents C. Reynold Verret and Walter Kimbrough have received injections as part of the Ochsner Medical Systems study.In a letter they penned to students, they encouraged others in the Black community to also participate. The letter read in part: "It is of upmost importance that a significant number of black and brown subjects participate so that the effectiveness of these vaccines be understood across the many diverse populations the compromise the United States." Verret and Kimbrough said they both have received their first injections and have been monitoring and reporting any symptoms they have. Both said they understood the possible risks by participating in the trial. They close the letter by appealing to students, faculty and staff to consider participating in the trial. About the Ochsner Vaccine TrialOchsner is participating as a study site for the Phase 2/3 global study sponsored by Pfizer Inc. and BioNTech SE of an investigational vaccine, BNT162b2, against COVID-19. Ochsner is one of only 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants. The site is one of two locations in Louisiana to offer the study.Led by Ochsner Principal Investigator Dr. Julia Garcia-Diaz, the study will enroll a limited number of randomized participants from across Louisiana who previously expressed interest in COVID-19 research.The trials goals will be prevention of COVID-19 in those who have not been infected prior to immunization, prevention of COVID-19 regardless of whether participants have previously been infected and the prevention of severe COVID-19 in those groups.If you are interested in learning more or participating, please email COVIDVaccine@ochsner.orgor leave a message at (504) 703-8283
The presidents of Dillard and Xavier University have signed up for the COVID-19 vaccine trial and are encouraging others to do so as well.
Presidents C. Reynold Verret and Walter Kimbrough have received injections as part of the Ochsner Medical Systems study.
In a letter they penned to students, they encouraged others in the Black community to also participate.
The letter read in part:
"It is of upmost importance that a significant number of black and brown subjects participate so that the effectiveness of these vaccines be understood across the many diverse populations the compromise the United States."
Verret and Kimbrough said they both have received their first injections and have been monitoring and reporting any symptoms they have.
Both said they understood the possible risks by participating in the trial.
They close the letter by appealing to students, faculty and staff to consider participating in the trial.
About the Ochsner Vaccine Trial
Ochsner is participating as a study site for the Phase 2/3 global study sponsored by Pfizer Inc. and BioNTech SE of an investigational vaccine, BNT162b2, against COVID-19. Ochsner is one of only 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants. The site is one of two locations in Louisiana to offer the study.
Led by Ochsner Principal Investigator Dr. Julia Garcia-Diaz, the study will enroll a limited number of randomized participants from across Louisiana who previously expressed interest in COVID-19 research.
The trials goals will be prevention of COVID-19 in those who have not been infected prior to immunization, prevention of COVID-19 regardless of whether participants have previously been infected and the prevention of severe COVID-19 in those groups.
If you are interested in learning more or participating, please email COVIDVaccine@ochsner.orgor leave a message at (504) 703-8283
Gov. Chris Sununu is pictured speaking at his news conference Thursday in Concord.
CONCORD, NH Gov. Chris Sununu said New Hampshire will be ready once a COVID-19 vaccine is available in response to questions about a letter from the CDC to governors telling them to be prepared to distribute vaccines as soon as Nov. 1.
Sununu also announced at his regular press conference Thursday that he signed a new emergency order requiring learning center verification.
As to the vaccine, Sununu said: The federal government is saying a vaccine is likely on its way and wants to make sure were ready on our end for whenever that may come.
He said he doesnt think a vaccine will be ready by then, but the state will be ready in case. No vaccine has been approved, although there are trials underway.
Sununu said the bigger question will be the quantity of the vaccine doses and the timing of when they could arrive in New Hampshire, although the state will definitely be ready Nov. 1. There is also the question of prioritizing who will be among the first to be vaccinated, Sununu said.
They just want to make sure the states have crossed all their Ts and dotted their Is so when a vaccine is available, were ready to distribute it as fast as we possibly can, Sununu said.
The state wont get 1.3 million doses right away which would be enough for everyone, Sununu said.
Were assuming we might have to prioritize, Sununu said, adding that could include people in high-risk groups.
Sununu also said he just signed a new emergency order requiring remote learning center verification.
This will ensure that parents or legal guardians who may be in a situation where the school district has gone to remote or hybrid learning models have safe options for their kids should they choose to use a learning center or learning pod as they are sometimes called.
Sign up for those begin on Tuesday.
The Department of Health and Human Services will administer this program within the Child Care Licensing Unit.
The order states: A remote learning center shall be defined as any person, corporation, partnership, voluntary association or other organization, either established for profit or otherwise, which provides a space for children in kindergarten through grade 12 to participate in remote instruction through a public or private elementary or secondary school system or institution of higher learning.
The Department of Health and Human Services will develop a standard form for verification of a remote learning center. At a minimum, this form will include certification from the remote learning center that no individual working with any child:
a. Has a criminal conviction for an offense involving causing or threatening direct physical injury to any individual;
b. Has a criminal conviction for an offense involving causing or threatening harm of any nature to any child or children;
c. Has a felony conviction in the previous ten years;
d. Is listed on the New Hampshire Registration of Criminal Offenders Website (hltp ://business.nh.gov/NSOR/);
e. Is listed on the National Sex Offender Public Website (https://www.nsopw.gov/); and
f. Is ineligible for employment pursuant to RSA 189:13-a, V. 4.
The following are not considered remote centers: a. Daytime programs operated by a public or private elementary or secondary school system or institution of higher learning; b. Private homes in which the only children in care are the providers own children, children related to the provider or others. See the full list in Emergency Order #67here.
Health and Human Services Commissioner Lori Shibinette provided more details on the states preparedness for delivering COVID-19 vaccinations.
The state has been preparing for delivering COVID-19 vaccinations since June, Shibinette said. And beyond that the state has for a long time had plans in place and continuing drills on prioritizing and delivering vaccines for other illnesses.
Were in a good place for mass vaccination, Shibinette said.
Shibinette also announced 41 new positive COVID-19 cases on Thursday, bringing the states total to 7,347 cases. She said there were no new hospitalizations and no new deaths to report. The state has had a total of 432 COVID-19 deaths since the beginning of the pandemic in March.
The state is closing the outbreak at Evergreen Place in Manchester leaving only one outbreak open the one at Mountain View in Ossipee, Shibinette said. An outbreak means there are three or more cases.
Sununu said hundreds of businesses have thousands of jobs available. He focused Thursday on job openings at schools. Check out those listings athttp://nhjobs.nh.gov, Sununu said.
Related
The director of infectious diseases at the University of Alabama at Birmingham says right now she would not take one of the COVID-19 vaccines currently in phase three clinical trials across the country.
During a press conference Thursday, Dr. Jeanne Marrazzo addressed the Centers for Disease Controls announcement that a vaccine could be ready by the end of October. She said the vaccines have been fast-tracked and not much is known about their long term effects or success rates.
Yes, I know theres urgency, but we should not sacrifice our convenience for the rush to get a product that we just dont know is really truly safe, Marrazzo said. We deserve the best. We deserve better. I mean people have been through hell with this thing.
Efficacy trials, or better known as phase three trials, help determine if a vaccine works. In the case of COVID-19, for a phase three trial to be successful it must show that the vaccine reduces the number of actual infections in people and that participants are able to make antibodies against the virus over time.
But now, Marrazzo said, those efficacy standards may change with the release of data from a vaccine trial in the United Kingdom earlier this week.
My big concern about this timeline thats now out there is that not only do we not have the kind of evidence for efficacy, yet. Yet. Im saying yet because maybe they know something I dont know. Thats always possible, Marrazzo said. But do we really have confidence that we can go out there and vaccinate everybody safely without knowing the longer-term benefits or side effects of this vaccine?
Marrazzo said she is also concerned that there is not enough information yet about long-lasting immunity to COVID-19, especially given recent reports of people being reinfected with the virus. She noted that the vaccines are based on a totally new technology.
We have never had a messenger RNA vaccine in a human population before these trials, Marrazzo said. We think its safe, but we dont know.
She added that vaccines can have serious side effects. Marrazzo said phase three trials typically follow participants for at least a year, if not longer, to track possible side effects. If a vaccine is released in late October, it would have only been studied in humans for eight months at most.
We need iron-clad proof and assurance to the extent that anybody can get it in any vaccine study or any medical study that whatever product we make widely available to our citizens is as safe and effective as humanly possible, Marrazzo said. We are not there, right now. Theres no way I have seen, myself, and I know that most experts have seen enough data to feel like not only today theres something to roll out but in seven short weeks that there would be something to roll out.
Marrazzo said ultimately the decision to get the vaccine is a risk-benefit analysis, but she will not get oneunless it is backed by the Advisory Committee on Immunization Practices. Meanwhile, Marrazzo said she plans on volunteering for a vaccine clinical trial.
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