As Michigan marked its worst day yet in the coronavirus pandemic, with newly confirmed cases hitting 6,473 Tuesday, Beaumont Health announced a trial of a potential vaccine on the heels of promising news about the effectiveness of Pfizer’s vaccine candidate.
Beaumont Health is now recruiting volunteers for a Phase 3 trial of AstraZeneca’s potential coronavirus vaccine, joining four other Michigan health care companies with ongoing studies in the race to find a safe and effective coronavirus vaccine.
The late-stage study of the vaccine, AZD1222, will take place at Beaumont’s Royal Oak hospital, and seeks people ages 18 or older in good health or with stable underlying conditions to join the trial.
“This large-scale study definitely has the potential to save lives across our state, the nation and across the globe,” said Dr. Matthew Sims, director of infectious diseases research at Beaumont Health.
No coronavirus vaccine candidate has received Food and Drug Administration authorization yet, though Pfizer announced Monday the potential vaccine it’s producing, BNT162b2, could be as much as 90% effective at preventing coronavirus infection in its trial participants based on early data.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” said Pfizer Chairman and CEO Albert Bourla in a prepared statement. “We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
Coronavirus cases are surging again in Michigan along with hospitalizations. So far in the pandemic, 7,724 Michiganders have died and 223,277 have had confirmed cases, according to state health data. The percentage of positive coronavirus tests rose above 14% on Monday — its highest point since April.
The United States has reported more than 10 million cases and 238,000 deaths from the virus, according to Johns Hopkins University’s COVID-19 Global Case Tracker.
How AstraZeneca’s vaccine trials work
AstraZeneca’s investigational coronavirus vaccine was created by the British pharmaceutical company with researchers at the University of Oxford and its spinoff company, Vaccitech.
In all, AstraZeneca is seeking about 40,000 volunteers for its study in the United States who have not had the coronavirus and are not enrolled in any other coronavirus vaccine trials.
In Michigan, both Beaumont and Michigan Medicine at the University of Michigan in Ann Arbor are hosting trials.
Those who take part in the AZD1222 trials are not told whether they are receiving the investigational vaccine or a placebo. Two-thirds of the study volunteers will receive the vaccine, and the other one-third will receive a placebo.
Volunteers who receive the recombinant vector vaccine get two injections spaced about four weeks apart. AZD1222 uses a modified version of a chimpanzee common-cold virus (adenovirus) containing the genetic spike protein found in SARS-CoV-2.
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.
AstraZeneca paused its trials of AZD1222 around the world in September because of a report of a serious illness in a study participant. Last month, the FDA gave the company permission to resume its trials in the United States, determining the illness could not be definitively tied to the vaccine.
If its vaccine is successful, AstraZeneca said it plans to supply 3 billion doses worldwide to the United States and partners in Russia, South Korea, Japan, China, Latin America and Brazil.
To learn more about the Beaumont trial or to enroll, go to www.beaumont.org/covid-trial.
To learn more about enrolling in Michigan Medicine’s trial, go to https://www.uofmhealth.org/covid19-vaccine.
Pfizer’s vaccine makes hopeful advances
With positive results coming from early data in Pfizer’s Phase 3 trial of BNT162b2, the company announced it ought to have enough information to seek FDA approval by the third week in November for its mRNA coronavirus vaccine.
Pfizer’s 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 the virus.
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 the patients who are enrolled 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 the coronavirus 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 already manufactured “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 last month.
If the clinical studies show the vaccine is safe and effective, the company has already established how it will distribute the vaccine.
New early data from the Phase 3 trials show that more people who received the placebo than the vaccine came down with COVID-19. They were protected a week after the second dose of the vaccine. As the large Phase 3 study continues, the level of effectiveness may vary.
Volunteers needed for Janssen study, too
Henry Ford Health System announced last week that it also is recruiting volunteers for a Phase 3 trial of a vaccine in development by Janssen Pharmaceutical Companies, a division of Johnson & Johnson.
Michigan Medicine and Cherry Health also have partnered with Janssen to offer this vaccine trial, which is called the Ensemble study.
Like AstraZeneca’s vaccine candidate, Janssen’s also is 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 has recently been granted authorization by the European Commission.
Half the participants will get a single injection of the vaccine in the double-blind trial. The other half will receive a placebo. Janssen is seeking 60,000 adults worldwide for the trials, with a significant portion older than age 60.
“We believe participating in this latest trial is an important part of our effort to stop this global pandemic,” said Dr. Adnan Munkarah, Henry Ford’s executive vice president and chief clinical officer in a statement.
“We hope southeast Michigan residents will consider taking part in the vaccine trial, particularly people who are at a higher risk of coming in contact with the virus, and people who have a higher likelihood of developing severe symptoms. I’d like to thank everyone who volunteers for contributing to the global effort to combat COVID-19.”
Phase 1/2a trials showed that 99% of participants ages 18-55 developed detectable coronavirus antibodies after one injection of the Janssen vaccine candidate. 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.
The Ensemble study was temporarily paused following an unexplained illness in a study participant earlier this year, but has since gotten FDA approval to resume trials in the U.S.
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 in a statement after it announced the temporary halt in its trials. “Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”
To learn more or to enroll in in the Ensemble study at Henry Ford, go to: https://www.henryford.com/j-and-j-vaccine.
To enroll in the University of Michigan’s Ensemble study trial, go to: https://www.uofmhealth.org/covid19-vaccine.
After trials, what comes next?
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. 22, the company reported that it had completed enrollment of 30,000 volunteers.
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.
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 in October 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.
Contact Kristen Shamus: firstname.lastname@example.org. Follow her on Twitter @kristenshamus. USA Today contributed to this report.