This story appeared in the Detroit Free Press. Read the full story here.
Health care workers will be the first people in Michigan to get a coronavirus vaccine, according to an interim priority plan state health officials released Tuesday evening for when a COVID-19 vaccine is green-lighted in the U.S.
After that, local health departments will distribute the vaccine in their communities, prioritizing the people most vulnerable to severe complications of COVID-19, according to a Michigan Department of Health and Human Services COVID-19 Vaccination Plan.
That would include first responders, people who live in or work at long-term care facilities, prisons or jails, homeless shelters or other congregate settings, people over age 65, and those with underlying chronic health conditions.
Because health officials anticipate high demand and shortages of the vaccine, especially initially, state public health departments were required to submit their plans to the U.S. Centers for Disease Control and Prevention by Oct. 16 as the race to develop an effective and safe vaccine enters the home stretch.
Phase 2 of Michigan’s plan also would include vaccinating essential workers at grocery stores, food distribution centers and other high-risk populations.
State health officials predict that the vaccine will be more accessible during Phase 3 of its plan, when it opens COVID-19 vaccination to the general public.
Vaccines would be available at pharmacies, local health clinics, hospitals and medical offices under the proposed plan.
Some of the COVID-19 vaccines under development will require a second, booster dose. Health officials say they’ll mail postcards to Michiganders and send text messages to remind them to get their second shot, and try to encourage people to get vaccinated through public health campaigns with the help of schools, churches and religious leaders, health insurance companies, employers, colleges and universities and local health departments.
But exactly when a successful coronavirus vaccine will be available and which company will be first to deliver it remain open questions.
Where COVID-19 vaccines stand
There are now at least 45 COVID-19 vaccine candidates in Phase 3 clinical trials worldwide, said Dr. Soumya Swaminathan, chief scientist at the World Health Organization, during a Monday news conference.
“We are looking at the beginning of next year, really, to start seeing data for many of the trials,” she said. “We may see one or two before the end of the year, but the majority will start reporting in early 2021. And that’s when we’ll be able to see the data.
“Many of these companies are already manufacturing several millions of doses. So as soon as the results are out, if it’s promising, companies will be able to start providing those doses.”
President Donald Trump announced Operation Warp Speed in May, a national effort to speed up the development, manufacturing and distribution of a COVID-19 vaccine with a goal of delivering 300 million doses starting in January.
Trump has criticized the WHO’s pandemic response, saying the global health organization was a tool of China. Trump formally cut U.S. ties with the WHO in July.
The United States also has refused to join an international collaboration of more than 170 countries to create a COVID-19 vaccine Global Access Facility, known as COVAX.
The mission of COVAX is to accelerate the development of coronavirus vaccines and guarantee equitable distribution once they are approved for use, prioritizing people at highest risk for severe illness and death worldwide. COVAX is led by the WHO, Gavi, the vaccine alliance, and the Coalition for Epidemic Preparedness and Innovations.
In explaining the U.S. refusal to join COVAX, White House spokesman Judd Deere told the Washington Post in September: “We will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China.”
That means America must count on its own companies to produce at least one safe and effective vaccine and to manufacture enough doses to distribute to all in this country who need it.
Public wary of vaccine safety
Even if clinical trials show that COVID-19 vaccines are safe and effective, whether Americans will believe that is another question.
A new survey from STAT News and The Harris Poll conducted Oct. 7-10 suggests Americans are increasingly wary. Of 2,050 people who were surveyed, 58% said they would get the vaccine as soon as it is available, down from 69% in mid-August.
The results showing rising vaccine hesitancy came after Trump campaigned on a promise that his administration would have a COVID-19 vaccine ready before Election Day, even though scientists have warned that safety protocols should not be rushed.
Pfizer Chairman and CEO Dr. Albert Bourla issued an open letter Oct. 16 to offer clarity and transparency about how the vaccine development process will work at Pfizer.
“We may know whether or not our vaccine is effective by the end of October,” he wrote. “To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates.”
Bourla said Pfizer will not apply for FDA emergency use authorization for its vaccine until the third week of November.
“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency,” Bourla said. “The timelines above reflect our best estimates of when these important milestones could be achieved.”
Similarly, AstraZeneca CEO Pascal Soriot issued a statement Aug. 31, insisting that patient safety comes first.
“In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible COVID-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work,” he said. “We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVD-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around world.”
Dr. Adnan Munkarah, chief clinical officer and executive vice president of the Henry Ford Health System, said public opinion about vaccine safety is crucial.
“If our community does not believe in the vaccine, we can do all the planning that we want to do, … but people are not going to come and get the vaccines because they feel that they won’t be safe,” he said.
“So the more we are consistent in our messaging, … the more we follow what the data and science are telling us, the better off we are.”
Pfizer manufactures thousands of COVID-19 vaccine doses
Pfizer’s vaccine, known as BNT162b2, was developed in conjunction with BioNTech, a German biotechnology company that until now has focused primarily on cancer treatments.
The potential vaccine uses a tiny piece of the coronavirus’ RNA, its genetic code, to trick the body into making proteins and mount an immune response that could protect people when they are exposed to COVID-19.
A successful mRNA vaccine has never before been developed and brought to market.
The Michigan Center for Medical Research in Farmington Hills is among 120 sites globally conducting the Phase 3 controlled, randomized trials of the Pfizer vaccine that will enroll as many as 30,000 people.
One-half of patients in the trial are getting injections of a placebo; the other half are getting two doses of the vaccine spaced either three weeks apart or two months apart. The Michigan arm of the trial is no longer enrolling new patients in the study, which will follow participants for two years to see whether they develop an immune response to COVID-19 or show any signs of infection.
In an earlier Phase I/2 randomized trial, all patients who received the Pfizer vaccine developed an immune response and had antibodies to SARS-CoV-2. No serious side effects were indicated, though some patients who received the vaccine reported fever, fatigue and chills.
Pfizer has readied “hundreds of thousands of doses” of its potential COVID-19 vaccine at its sites in Kalamazoo and Puur, Belgium, spokeswoman Kim Bencker told the Free Press Monday.
If the clinical studies show the vaccine is safe and effective, the company has already established how it will distribute the vaccine.
“Our contracts are with the governments and we’ll be providing doses according to their preferred channel and designated vaccination locations,” Bencker said. “We seek to work with governments to support distribution to their defined priority groups and we anticipate that points of vaccination will vary but may include hospitals, outpatient clinics, community vaccination locations and pharmacies.”
Moderna scales up manufacturing for its COVID-19 vaccine, too
Another potential mRNA vaccine for COVID-19 that shows promise was developed by Massachusetts-based biotech company Moderna in conjunction with scientists from the National Institute of Allergy and Infectious Diseases.
Its vaccine candidate, called mRNA-1273, is being tested at about 90 sites nationally as part of Phase 3 clinical trials. As of Oct. 16, the company reported 29,521 participants had enrolled.
Detroit-based Henry Ford Health System is among the U.S. sites that enrolled patients earlier this year in the randomized, placebo-controlled Coronavirus Efficacy (COVE) study.
Half the patients who enrolled received the vaccine; the other half received a placebo.
Those who got the vaccine were injected with two, 100-microgram doses, spaced 28 days apart, and are to be followed for two years to see whether the vaccine offers protection from contracting the virus or reduces the severity of the disease.
The results of the Phase 1 trial suggest it might. Preliminary data published in the New England Journal of Medicine showed that two doses of the vaccine given to 45 people one month apart produced a “rapid and robust” immune response.
Side effects from the lower doses of the vaccine were mild, and included fatigue, chills, headache or muscle pain. Some people reported fever after getting the second vaccine dose at the higher levels.
Moderna is scaling up its global manufacturing with a plan to deliver about 500 million doses per year — and possibly up to 1 billion doses per year — beginning in 2021.
More:First Michigan patients get Moderna’s COVID-19 vaccine candidate through Henry Ford study
Both the Moderna vaccine and Pfizer’s are mRNA vaccines, which present a challenge in they must be stored and transported under extremely cold conditions.
Munkarah told the Free Press Tuesday that the Detroit-based health system is planning now for those logistical challenges.
“I would say that the hospital systems are at a little bit of an advantage because we have the infrastructure” to store the doses at the proper temperature, Munkarah said.
His bigger question is how widespread vaccination of those mRNA vaccines will be handled in places like community centers and public health clinics where there isn’t access to freezers to properly store the doses.
The MDHHS Vaccination Plan outlines the protocol, saying the state agency will “ensure ultracold shipments are only delivered to sites that can appropriately store and handle such vaccine.”
It details the use of dry ice in coolers as well as ways to monitor the temperature inside those coolers to ensure the vaccines are properly stored and handled.
Johnson & Johnson pauses trials
The University of Michigan announced last week that it would partner with Janssen Pharmaceutical Companies, a division of Johnson & Johnson, to host a Phase 3 trial called the ENSEMBLE study of another potential coronavirus vaccine.
But hours later, Johnson & Johnson temporarily halted the study because of an unexplained illness in a participant.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians,” the company said in a statement.
The Johnson & Johnson vaccine is known as a recombinant vector vaccine. It was created by modifying a human adenovirus, which causes the common cold, with the genetic spike protein found in SARS-CoV-2. It’s the same method used to create an Ebola vaccine that’s recently been granted authorization by the European Commission.
Serious adverse reactions “are not uncommon in clinical trials, and the number … can reasonably be expected to increase in trials involving large numbers of participants,” the company said. “Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”
The company did not disclose what kind of illness was reported, saying in a statement: “It’s important to have all the facts before we share additional information.”
If or when the trial resumes, half the participants will get a single injection of the vaccine. The other half will receive a placebo.
Phase 1/2a trials showed that 99% of participants ages 18-55 developed detectable coronavirus antibodies after one injection. And 29 days after they were vaccinated with a single dose, 98% had neutralizing antibodies against SARS-CoV-2. The vaccine also was shown to create T-cell responses.
Side effects reported in early trials of the Johnson & Johnson vaccine were mild to moderate and generally included fever, headache, injection site pain, fatigue and aches and pains.
AstraZeneca’s U.S. trial still halted
Another COVID-19 vaccine Phase 3 trial hosted at the University of Michigan also has been stymied by a temporary pause to investigate reports of unexplained illness.
AstraZeneca also halted the Phase 3 trials of its investigational COVID-19 vaccine in early September, following reports that a patient in the United Kingdom had developed an unexplained neurological illness.
That announcement came just days after Michigan Medicine announced it was recruiting patients to enroll in the trials of the vaccine, AZD1222.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” AstraZeneca said in a statement.
“In large clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”
The AstraZeneca vaccine candidate, which was created by the British pharmaceutical company in conjunction with researchers at the University of Oxford and its spinoff company, Vaccitech, is a recombinant vector vaccine.
It uses a modified version of a chimpanzee common-cold virus (adenovirus) containing the genetic spike protein found in SARS-CoV-2.
AstraZeneca has resumed international Phase 3 trials, but has yet to restart in the United States.
“AstraZeneca continues to work with the Food & Drug Administration to facilitate review of the information needed to make a decision regarding resumption of the US trial,” the company said in an Oct. 2 statement. “The safety of trial participants is of paramount importance and we are committed to upholding the highest standards of conduct in clinical trials.”
The AstraZeneca vaccine is given in two doses, spaced about a month apart. One-third of people who enroll in the randomized, placebo-controlled trial get the placebo and two-thirds get the vaccine.
Participants in both studies will be followed for about two years after they receive their injections to see whether they develop antibodies to COVID-19 or whether they contract the virus.
The outcome of earlier phases of AZD1222 trials were published in The Lancet in July, and showed the vaccine produced a “robust” immune response, including SARS-CoV-2 antibodies, in all evaluated participants. A second booster dose of the vaccine elicited neutralizing antibody titers.
Mild to moderate side-effects included fatigue, headache, fever, chills and body aches.
If its vaccine is successful, AstraZeneca said it plans to supply 3 billion doses worldwide to partners in Russia, South Korea, Japan, China, Latin America and Brazil.