Late Trials, Short Supply and Hesitancy Hobble MI COVID Vaccine Rollout
By PAUL NATINSKY
The American Academy of Pediatrics began advocating for COVID vaccine trials for children back in November, but recent reports show that trials for children older than 12 years have just begun and data for children ages 1 to 11 is not expected until 2022. The COVID vaccine is currently approved for adults age 18 and older.
Vaccine-maker Moderna expects the company’s vaccine to be approved for children 12 years and older by the beginning of the 2021-2022 school year.
“For younger children, you have to go down in age very slowly and you have to start at a lower dose to make sure it is safe,” said Moderna CEO Stephane Bancel in November.
But AAP leaders write that children should be highly prioritized, and the sooner the better.
“It is counter to the ethical principle of distributive justice to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine, or to delay that benefit for an extended period of time, because they have not been included in vaccine trials,” stated AAP President Dr. Sara Goza in a Sept. 29 letter to FDA leadership.
“Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns,” she continued. “Questions about unknown safety concerns will not be answered by posing questions, but only through carefully designed trials which include children.”
Pediatricians Feel Shortage
In addition to frustrations about the pace of vaccine trials in children, pediatricians have concerns about access to the vaccines for themselves and other frontline healthcare providers.
“Pediatricians across the country are frustrated at the uneven and haphazard distribution of COVID-19 vaccines. Many AAP members and other physicians have no clear path to receiving the vaccine, especially those who do not work for a large medical center or hospital system,” reported the AAP Jan. 12.
Physician concerns on vaccine availability mirror those of society in general as the vaccine rollout suffers from changing guidelines, short supplies and a slow distribution system.
Michigan is 30th among states for administering an initial dose and 28th in getting both doses, according to a Jan. 16 report from the non-profit news source Bridge Michigan. Just under 350,000 statewide have received at least one dose and, of those, 57,000 have received the second.
While Michigan’s numbers for vaccine distribution are near the bottom, nationally, shortages and miscommunications from the federal government about how many doses were held in reserve lead Gov. Gretchen Whitmer and several of her Midwest gubernatorial colleagues to push for permission to buy vaccine directly from manufacturers.
Once supply and logistics problems are resolved and clinical trials complete, other longstanding problems wait on the horizon.
A number of healthcare professionals are reluctant to vaccinate themselves.
“We did a survey right before the vaccine came out ... basically as to where you work in the hospital, and would you or would you not get the vaccine when it is your turn? We came up with, 60 percent said yes, and 40 percent actually said no,” said Dr. Nikhila Juvvadi, the chief clinical officer at Chicago's Loretto Hospital in a Jan. 1 NPR report.
Juvvadi said some reasons for vaccine hesitation are reasonable, others perceived based on experiences, particularly for the staff at Loretto, majority-Black community on Chicago's West Side.
“There's a lot of different factors, but there's some things [that] are reasonable…Pregnant women or breastfeeding women can say that there's not enough research. So those type of things I tend to understand,” said Juvvadi.
“But then there's a wider hesitancy that almost is not rooted in the available science,” she continued “In the African-American population and to some extent in the Latino population, there are reasons for this…There's no transparency between pharmaceutical companies or research companies — or the government sometimes — on how many people from those communities were actually involved in the research. So they have — they have an issue with that.”
A Dec. 15 Kaiser Family Foundation report stated that about one-quarter of the general population was vaccine-hesitant, a number that had decreased from surveys taken last fall.
Outside of trepidation about the effects of a quickly developed new vaccine and legacy fears about government programs in minority communities, the growing “antivaxxer” movement adds a specific mistrust of all vaccines to the mix.
“Unfortunately, fear, mistrust, and misinformation about a potential SARS-CoV-2 vaccine is being spread from a vocal, well-established, and growing anti-vaccination movement,” stated Goza in her Sept. 29 letter to the FDA. “For a SARS-CoV-2 vaccine to be effective in controlling the pandemic, it must not only be safe and effective, but must also be embraced by medical providers and the public.
“For this to occur,” she continued,” Americans must have trust and confidence in the processes by which these vaccines are being tested for both safety and efficacy, and in the transparency of the scientific basis for licensure and recommendations for use. If that trust is jeopardized, mistrust of SARS-CoV-2 vaccines could become widespread and result not only in reduced uptake of SARS-CoV-2 vaccines but also in decreased confidence in all vaccines. If this were to happen, tens of millions of American lives would be at risk from the diseases prevented by our current vaccines.”
Help On The Way
Still, the biggest immediate problem is supply. State health officials reported Jan. 12 that more than 2.5 million Michigan residents are eligible to receive the COVID-19 vaccine, but there isn't enough available to vaccinate everyone who qualifies, according to reporting by the Detroit News.
An estimated 2,576,000 Michiganders are considered eligible for the vaccine, Michigan Department of Health and Human Services spokeswoman Lynn Sutfin said in an email to The News.
The News further reported about 802,000 of those are paid or unpaid health care workers and long-term care staff who qualified to be vaccinated during Phase 1a of the state's vaccine rollout. Another 702,000 people became eligible last Jan. 6 when Gov. Gretchen Whitmer opened vaccinations to everyone 65 or older.
"MDHHS is committed to accelerating vaccine delivery as we work to reach our goal of vaccinating 70 percent of Michiganders over age 16 as quickly as possible with the safe and effective COVID-19 vaccine," Sutfin told the News.
The state is working to make vaccine available to any Michigander over age 65 and accelerating vaccinations for our preK-12, day care staff and other essential frontline workers, according to published reports. Michigan health officials are collaborating with the federal pharmacy program to accelerate delivery and working to address vaccine hesitancy in nursing homes; and are accelerating distribution with the National Guard, according to reports.
Gov. Gretchen Whitmer asked the federal government for permission Jan. 11 for the state to make a one-time purchase of up to 100,000 doses of COVID-19 vaccine directly from Pfizer Inc.
Large-scale vaccination centers, which have been swiftly set up across the state, have the capacity to inoculate tens of thousands of people per day. But appointments have been dramatically limited to the number of doses on hand and are filling up as soon as they become available, health care providers have told The News.
Michigan expected to receive an allotment of 60,450 doses of the Pfizer vaccine by mid-January, according to reports.