COVID-19 vaccine begins to roll out
The first COVID-19 vaccines have already been administered overseas as FDA approval is still underway in the U.S.
A 90-year-old woman in the United Kingdom was the first Briton to receive the first of two doses on Monday at University Hospital in Coventry. The vaccine being administered at the UK hospital is the one released by Pfizer-BioNTech, which still hasn’t cleared all regulatory hurdles here in the U.S.
As of Tuesday morning, the Food and Drug Administration website still states that no COVID vaccine has been approved or authorized by the FDA.
“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake,” said Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research.
Back in July, the U.S. announced a deal with Pfizer and BioNTech to purchase 100 million doses of the vaccine, which is enough to vaccinate about 50 million people with two doses each, but that’s only 15 percent of the U.S. population. The U.S. also has a $1.5 billion deal with Moderna to purchase another 100 million vaccine doses.
Johnson & Johnson, Novavax and AstraZeneca have also produced vaccines, but according to a Forbes article, those are unlikely to receive emergency use authorization from the FDA before the end of 2020.
An FDA advisory committee and the Center for Biologics Evaluation and Research is set to meet Dec. 10 to discuss the Emergency Use Authorization for the Pfizer-BioNTech vaccine in people 16 and older. Another meeting will be held Dec. 17 to discuss emergency use authorization for the Moderna vaccine.
While the elderly patients in Great Britain were quoted as being honored and happy to be the first to receive the vaccine, many Americans don’t have the same enthusiasm and are concerned about its safety due to the rapid development and testing. Typically, vaccines require years of research and testing before being approved, but the U.S.’s Operation Warp Speed has the COVID-19 vaccine on the fast track.
“We understand that some people may be concerned about getting vaccinated once a COVID-19 vaccine is available in the United States,” the CDC website states. “While these vaccines are being developed as quickly as possible, routine processes and procedures remain in place to ensure the safety of any vaccine that is authorized or approved for use. Safety is a top priority, and there are many reasons to get vaccinated.”
According to a New York Times vaccine tracker, 41 vaccines were tested for safety and dosage in phase one, 17 vaccines moved on to phase two for expanded safety trials, 13 vaccines moved into phase three for large-scale efficacy tests and seven vaccines were approved for early or limited use.
In phase three, the vaccine is given to thousands of people to see how many become infected compared to volunteers who were given a placebo. In June, the FDA told vaccine producers that it wanted evidence that the vaccine would protect at least 50 percent of those who received it. According to the CDC, China and Russia approved COVID vaccines before waiting for results of phase 3, which poses serious risks.
On Nov. 9, Pfizer and BioNTech presented preliminary data indicating their vaccine was more than 90 percent effective. Just a week later, Moderna reported similar data and results. Now both companies are requesting emergency use authorization from the FDA before it can begin distributing the vaccine in the U.S.
The CDC and the FDA have expanded safety monitoring systems to be able to evaluate the vaccine in real time. V-SAFE is a new Smartphone-based health checker for people to use after they receive the vaccine. V-SAFE will use text messaging and web surveys from the CDC to check in with the health of recipients after being vaccinated. The CDC will also utilize the National Healthcare Safety Network to monitor acute care and long-term care facilities and reporting to the Vaccine Adverse Event Reporting System.
The FDA will use other large insurer/payer databases, a system of administrative and claims-based data for surveillance and research purposes. There are also a number of existing safety monitoring systems (www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html) in place for the CDC and FDA to follow.
Access to the vaccine will be limited at first until more doses become available in early 2021. In the meantime, more vulnerable populations will receive first priority for the vaccine. Based on recommendation from the Advisory Committee on Immunization Practices, the CDC made an official recommendation Dec. 2 that healthcare personnel and long-term care facility residents should be the first people offered the vaccination.
Vaccine doses purchased with U.S. tax dollars will be free to Americans, but the CDC says providers can charge administration fees for giving someone the shot. The fee may be reimbursed by a patient’s insurance provider.
North Carolina’s plan
North Carolina released its interim COVID-19 vaccination plan on Oct. 16. According to N.C. Department of Health and Human Services website, vaccine testing was “thorough and successful” with more than 70,000 people participating in clinical trials for two vaccines and a 95 percent efficacy rate in preventing the virus.
“There is no COVID-19 virus in the vaccine. The vaccine imitates the infection so that our bodies think a germ like the virus is attacking. This creates the antibody defenses we need to fight off COVID-19 if and when the real germ attacks,” the DHHS website stated. “No major side effects. Some people may have temporary reactions after being vaccinated, such as swelling from the injection, tiredness or feeling off for a day or two.”
Once health care workers and nursing home patients receive the vaccine, adults with the highest risk of illness and those at highest risk of exposure receive the next priority. This includes adults with cancer, COPD, serious heart conditions, sickle cell disease, type 2 diabetes and more. Those at highest risk of exposure include front line workers like police, food processing, teachers, those incarcerated in prison, people staying at homeless shelters and people with chronic conditions living in migrant housing.
Third priority will be adults 65 and older with chronic conditions; fourth priority will be K-12 and college students and critical industry workers and finally everyone who wants a vaccine can get it in stage 5.
In a recent press conference, Gov. Roy Cooper said he expected to receive about 85,000 doses in the first shipment of the Pfizer-BioNTech vaccine. The vaccine, which has to be kept in extreme cold storage until it’s used, will first be sent to hospitals across the state that have the greatest capacity for the cold storage.
NCDHHS plans to ship the first doses to
• Bladen Healthcare LLC (Bladen County Hospital)
• Caldwell Memorial Hospital
• CarolinaEast Medical Center
• Catawba Valley Medical Center
• Cumberland County Hospital System Inc (Cape Fear Valley Health System)
• Duke University Health System
• Henderson County Hospital Corporation (Margaret R. Pardee Memorial Hospital)
• Hoke Healthcare LLC (Hoke Hospital)
• The Charlotte-Mecklenburg Hospital Authority (CMC Enterprise)
• University of North Carolina Shared Services Agreement
• Wake Forest Baptist Health
Expecting “vaccine hesitancy” to be high, N.C. plans to focus on public education to build a foundation of trust. Key initial goals will be to increase knowledge of the vaccine and the development process; set expectations for limited availability at the onset of the vaccine delivery; raise awareness and recognition of historical injustices to mitigate vaccine hesitancy.
There’s also been a lot of talk about whether COVID-19 vaccines will be mandatory either on the state or federal level. The N.C. DHHS has stated it has no plans to make vaccines mandatory, but private businesses do have the ability to mandate employees to get vaccinated if they choose to do so. Many health care providers already require their employees to be immunized for certain diseases and viruses, including influenza.