Vaccine development is complicated. We break down the process from testing to distribution, and bring you the latest on the leading contenders for a COVID-19 vaccine.
Caroline Chen, health care reporter for ProPublica. (@CarolineYLChen)
Florian Krammer, professor of microbiology at the Icahn School of Medicine at Mount Sinai. His research focuses on immunology, infectious disease, vaccine development, viruses and virology. (@florian_krammer)
Dr. Stanley Perlman,professor of microbiology, immunology and pediatrics at the University of Iowa. He has studied coronaviruses for nearly 40 years. (@UIowaMicroBio)
ProPublica:"How and When Can the Coronavirus Vaccine Become a Reality?" "Its been six months since researchers in China said they had identified a novel coronavirus spreading in the city of Wuhan. Hope and desire for a vaccine to end the global devastation is growing with each passing week."
CNN:"First Phase 3 clinical trial of a coronavirus vaccine in the United States begins" "The first Phase 3 clinical trial of a coronavirus vaccine in the United States began Monday. The investigational vaccine was developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial is to be conducted at nearly 100 US research sites, according to Moderna. The first patient was dosed at a site in Savannah, Georgia."
Business Insider: "You're going to need more than one coronavirus shot. One dose of a vaccine probably won't be enough, experts say." "We're all holding our breath for a coronavirus vaccine for the day everyone can line up, get a shot, and then finally return to life as normal."
ProPublica: "'Fast-Tracking' a Coronavirus Vaccine Sounds Great. Its Not That Simple." "Pharmaceutical companies are racing to develop a coronavirus vaccine, with the most ambitious timelines ever attempted in history."
Wall Street Journal:"Coronavirus Vaccine Data Raises Hope for Trio of Candidates" "The prospects of successfully developing a coronavirus vaccine as soon as this year were buoyed Monday when three of the worlds leading candidates reported positive early trial data."
Twitter ThreadReader: "Antibodies/Immunology" "'There is a lot of talk about decaying antibodies.'"
The Telegraph:"Risk, uncertainty and fear of failure: Why scientists aren't celebrating a coronavirus vaccine yet""In 1976, when a mysterious new flu began spreading in the north-eastern United States a few months before the presidential election, President Gerald Ford raced ahead with a high-profile campaign to vaccinate the nation. The flu strain turned out to be rather mild and the vaccine caused several hundred people to develop paralysing Guillain-Barr syndrome."
Bloomberg:"The Worlds Supply Chain Isnt Ready for a Covid-19 Vaccine" "The industries that shepherd goods around the world on ships, planes and trucks acknowledge they arent ready to handle the challenges of shipping an eventual Covid-19 vaccine from drugmakers to billions of people."
Axios: "The state of the global race for a coronavirus vaccine""Vaccines from the U.K., U.S. and China are sprinting ahead in a global race that involves at least 197 vaccine candidates and is producing geopolitical clashes even as it promises a possible pandemic escape route."
Usually, vaccines are developed over the course of several stages, starting with testing in petri dishes and animals. The small fraction of these that show some promise then enter several phases of human trials, where researchers administer the vaccine to an increasing number of people while monitoring the dosage and assessing side effects and efficacy.
In Phase 3 (the last phase before FDA approval), researchers separate the participants into two groups, and administer the vaccine to one group while giving the other a placebo.
Researchers typically wait several months as the participants lead their lives, going to work, seeing family members or taking public transportation. If fewer people who received the vaccine than those given the placebo end up getting infected, it is deemed effective.
Because doctors have an ethical duty to minimize harm, they generally avoid purposely infecting people with a virus. But the usual process of waiting to see how many of the participants are naturally infected takes a long time.
And if the trials are being conducted in a place where community spread is low, participants in both groups may never be exposed to the virus, and researchers would have a hard time determining whether the vaccine works.
An organization called 1Day Sooner, which advocates for the use of "human challenge" trials in the development of a Covid-19 vaccine, asks people (especially those who are young and have no underlying health conditions) to enter their names online and state that they are willing to volunteer to take part in such a trial.
On paper, this approach seems straightforward and full of potential, given that the world is desperate to develop a Covid-19 vaccine. But it is critical that the process -- along with the final product -- is as safe as possible, especially given the mistrust of science in this country and the growing anti-vaxxer movement. This novel study design raises several significant problems that have not yet been resolved.
It remains unclear whether controlled infection trials will be implemented, or how. Proponents of these trials say they might need about 100 participants for each study. If researchers took this approach for 20 studies, 2,000 people would be infected with Covid.
Most vaccine trials are designed to test whether the product leads people to develop antibodies, not whether the vaccine actually prevents infection. Even if an experimental vaccine causes someone to develop antibodies, they might not successfully trigger all the components of the body's immune system to effectively attack the virus.
A vaccine may also only be partially effective and could cause significant side effects. It might, for instance, create antibodies only in perhaps 50% or 60% of participants, and cause serious illness in 10%.
The incident has helped fuel the anti-vaxxer movement ever since.
Unfortunately, given the ever-rising costs of drugs in the US, pharmaceutical companies that end up developing a successful vaccine may charge a significant amount of money for it.
Proponents of challenge studies have also largely ignored the question of whether participants (or their family members) will be compensated if they end up with long-term medical problems or die as a result of the trial.
While we shouldn't automatically reject the possibility of human challenge trials, given the number of lives that could be saved with an early vaccine, we need to proceed very cautiously.
If we do embark on these trials, researchers should be even more selective about which experimental vaccines to use. Drug companies should also commit to making the vaccine, if it is approved, affordable for millions of people.
Researchers, should they embark on controlled infection trials, should administer the vaccine and infect only a handful of participants at a time, and check whether it's effective before giving it to additional subjects to minimize any potential damage.
Informed consent and robust guidelines for all participants is crucial, and researchers should quiz each participant to guarantee that he or she fully understands the potential risks.
We all want a safe, effective and widely available vaccine, but researchers need to ensure that participant safety is also thoroughly considered.
Coronavirus vaccines: What looks promising and who will be the first to get one? The Mercury News
A vaccine with the potential to be ready for distribution before the end of the year now moves into the final phase of testing, and Cincinnati is playing a key role in the research.The Moderna vaccine is being tested in the labs at the University of Cincinnati College of Medicine.We get to contribute to the solution and to have Cincinnati and our community to be involved in that is amazing, said UC College of Medicine faculty member Dr. Maggie Powers-Fletcher. Im thankful, and our study team is so grateful, to have this opportunity to participate.The Moderna study moved into phase three, which is when they inject about 30,000 people to see if the vaccine is effective and for how long.UC is one of about 100 testing laboratories across the nation involved in testing the vaccine for the Moderna study.Its very exciting. Were getting the ball rolling on a very important effort to learn more about the use and success of the vaccine against COVID-19, said Powers-Fletcher.This week, some sites are starting the first of two injections that will be given about a month apart. UC will begin their first injections in August.This is a unique vaccine in that its part of the genetic code, only a piece of the genetic code, that creates or prompts your body to make something that triggers your immune system, Powers-Fletcher said.The goal is to have a safe and effective vaccine ready before the end of 2020.The UC College of Medicine lab is within sight of the lab at Childrens Hospital where the Pfizer vaccine, which is also considered to be very promising, is being tested.Both studies are still looking for volunteers to participate in the research. To sign up for the UC Moderna study, click here or call 513-245-3417.To sign up for the Children's Pfizer study, email gambleprogram@cchmc.org or call 513-636-7699.
A vaccine with the potential to be ready for distribution before the end of the year now moves into the final phase of testing, and Cincinnati is playing a key role in the research.
The Moderna vaccine is being tested in the labs at the University of Cincinnati College of Medicine.
We get to contribute to the solution and to have Cincinnati and our community to be involved in that is amazing, said UC College of Medicine faculty member Dr. Maggie Powers-Fletcher. Im thankful, and our study team is so grateful, to have this opportunity to participate.
The Moderna study moved into phase three, which is when they inject about 30,000 people to see if the vaccine is effective and for how long.
UC is one of about 100 testing laboratories across the nation involved in testing the vaccine for the Moderna study.
Its very exciting. Were getting the ball rolling on a very important effort to learn more about the use and success of the vaccine against COVID-19, said Powers-Fletcher.
This week, some sites are starting the first of two injections that will be given about a month apart. UC will begin their first injections in August.
This is a unique vaccine in that its part of the genetic code, only a piece of the genetic code, that creates or prompts your body to make something that triggers your immune system, Powers-Fletcher said.
The goal is to have a safe and effective vaccine ready before the end of 2020.
The UC College of Medicine lab is within sight of the lab at Childrens Hospital where the Pfizer vaccine, which is also considered to be very promising, is being tested.
Both studies are still looking for volunteers to participate in the research.
To sign up for the UC Moderna study, click here or call 513-245-3417.
To sign up for the Children's Pfizer study, email gambleprogram@cchmc.org or call 513-636-7699.
Moderna and Pfizer are the first companies to enter Phase 3 clinical testing on a COVID-19 vaccine in the U.S. Each company plans to blind test 30,000 volunteers in hopes of having results and possibly effective vaccines by the end of the year. Meg Oliver reports.
As the world waits with baited breath for a safe and effective vaccine to prevent SARS-CoV-2, the new coronavirus that causes COVID-19, people living with HIV are concerned that they may be excluded from clinical trials testing these vaccines.
Following the publication this month of promising data from early-stage trials, two vaccine candidatesone being developed by the National Institute of Allergy and Infectious Diseases (NIAID) and the biotechnology company Moderna, the other by the University of Oxford and AstraZenecaentered the final stage of testing this week.
But the trial protocol for the NIAID-Moderna vaccine, available on ClinicalTrials.gov (study number NCT04470427), excludes people with an immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection.
This really stinks! What a great way to begin the U.S. Phase III vaccine effortlets exclude people with HIV, longtime advocate Lynda Dee of AIDS Action Baltimore told POZ. Apparently, the HIV exclusion was added to a new version of the protocol unbeknownstto many stakeholders. Were going to do our very best to make Moderna amend the HIV exclusion.
Dee and a growing group of advocates have issued a sign-on letter to the director of the National Institutes of Health (NIH), which oversees NIAID, demanding that they do not exclude people with HIV. A copy of the letter will be sent to pharmaceutical companies developing COVID-19 vaccines.
In the era of effective antiretroviral therapy, most HIV-positive people on treatment do not have immune suppression because the medications halt viral replication and allow CD4 T-cell counts to return to near-normal levels. Studies so far have found that people living with HIV are neither at greater risk for SARS-CoV-2 infection nor more likely to develop severe COVID-19 or to die from it.
The NIAID-Moderna trial protocol states that it will include healthy adults or adults with preexisting medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the three months before enrollment.
The Oxford-AstraZeneca trial protocol (study number NCT04400838) excludes people with any confirmed or suspected immunosuppressive or immunodeficient state but does not specifically mention HIV. All study sites for this vaccine trial are in the United Kingdom.
While most HIV-positive people on treatment fall into the stable disease category, advocates fear that the explicit HIV exclusion criterion in the NIAID-Moderna protocol will create confusion and be interpreted as taking priority.
And in fact, this has already happened. Jeff Taylor of the HIV+Aging Research Project, another longtime advocate, called a local study site listed in the trial description and was told that he could not enroll because he is HIV positive, even though he met all the otherstudy criteria."
I was shocked to see that HIV was specifically excluded, Taylor told POZ. "There is no need to exclude the 1.2 million people living with HIV from getting this vaccineespecially since more than half are older than 50 and at increased risk for severe illness or dying from COVID.
Decades of research have proven that HIV-positive people with undetectable viral loads and a safe CD4 count respond to vaccines, and are encouraged to receive all recommended vaccinations, he continued. It shouldgive us pause to see an inexperienced company with a lack of basic scientific knowledge is in charge of a hugely important vaccine trialat a huge cost to taxpayers.
Sign-On Letter
According to Dee, Carl Dieffenbach, PhD, director of NIAIDs Division of AIDS, said he would request an amendment to the protocol after the trial opens.
But advocates are in no mood to wait, concerned that HIV-positive people eager to participate in the study will be turned away, as Taylor was, before the amendment makes its way through the system and filters down to local study site coordinators.
In an effort to increase the pressure to change the NIAID-Moderna criteriaand to ensure that other companies developing COVID-19 vaccines do not make the same mistakeadvocates issued a sign-on letter to NIH director Francis Collins, MD, PhD.
We are extremely dismayed to learn that a COVID-19 vaccine candidate developed with significant contributions from researchers at the NIH excludes people with HIV with no scientific basis, reads the letter. We want to be sure you are aware of this situation, will do everything in your power to intercede with Moderna to reverse this exclusion and ensure that such an exclusion never happens again.
There is no clinical justification for excluding people with HIV from COVID-19 vaccine trials. Thanks to the advent of triple combination antiretroviral therapy in the mid-1990s, HIV infection has not been synonymous with an immunodeficient state for over two decades, the letter continues. At most, CD4 T-cell threshold criteria might be employed if there are concerns about people with very low counts being able to mount insufficient vaccine responses. If there are concerns about a unique immune response for people with HIV, this can be studied through a subset analysis of participants with HIV. This approach should be considered for participants with other controlled comorbidities, and is especially important with respect to communities of color, who are disproportionately affected and suffer disparate outcomes from both HIV and SARS-CoV-2 infections.
Whats more, the NIAID-Moderna exclusion sets a terrible precedent, not grounded in any scientific data, the letter states. If the Moderna vaccine is approved by the [Food and Drug Administration], there will be no data on its safety or efficacy in people with HIV. Thus, there will probably not be an FDA indication for people with HIV or payer reimbursement as a result.
The FDA has been explicitlyclear that people living with HIV on sustained treatment should be treated as healthy volunteersfor clinical trials, Ace Robinson of NMAC told POZ. Furthermore, the racial and ethnic minority communities experiencing the worst HIV-related health outcomes are the exact same ones that are experiencing the worst COVID-19 health outcomes. We must do better to engender trust in these communities. This oversightby Moderna is yet another step backward in establishing medical trust between clinical development and communities of color. Moderna and other biotech firms must be held to the highest standards even when we are moving at warp speed.
Initial signatories on the letter include some of the big names in HIV advocacy, including Mark Harrington and Richard Jefferys of the Treatment Action Group, Guillermo Chacon of the Latino Commission on AIDS, Moises Agosto of NMAC, Murray Pennerof the Prevention Access Campaign, Mitchell Warren of AVAC and Bruce Richman of the Prevention Access Campaign.
Community members are encouraged to sign on to the letter as well.
Posted: Jul 28, 2020 / 06:00 PM EDT / Updated: Jul 28, 2020 / 06:00 PM EDT
(WSYR-TV) Hopes are high for a coronavirus vaccine early in the new year. Whether that happens depends on testing being done right now.
In fact, 27 vaccines are being tested on people right now.
The largest study took a huge step forward this week when the experimental shot was given to the first of 30,000 people at 89 sites around the country.
Half of the people will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine.
Researchers will then monitor the subjects, looking for side effects and waiting to see if significantly fewer vaccinated people get COVID-19, indicating that the vaccine works.
The main goal is to determine whether the vaccine can prevent the illness.
The study will also try to find out if it can prevent severe COVID-19 and death, if it can prevent infection entirely based on lab tests and if just one shot can prevent the illness.
The full enrollment of 30,000 people in the trial is expected to be completed by the end of the summer and results might be available by November.
At least three more so-called Phase Three trials will be starting soon, each also needing 30,000 patients.
A second company, Pfizer, announced late Monday afternoon that it had also begun a late-stage study of a coronavirus vaccine.
The first subjects in that study received injections at the University of Rochester on Monday.
MJH Life Sciences will host COVID-19: Race for a Vaccine, a free, live, 1-hour webinar, Thursday, July 30, at 6 p.m. EDT.
Investigators and scientists around the globe are racing the clock to develop a vaccine against SARS-CoV-2, the virus that causes COVID-19. With a handful of candidates entering phase 3 trials, huge investments from governments for the first 100 million doses, case counts continuously ticking upward and policymakers working to untangle the logistical knots of distribution, the race for a COVID-19 vaccine is one of the most urgent public health challenges in modern history.
This panel discussion will feature the top minds in infectious diseases, virology and vaccinology, who will give participants a breakdown of the top vaccine candidates and the latest information on clinical trials. They will also discuss how to combat logistical challenges associated with rolling out a vaccine in the middle of a global pandemic.
Expert panelists includeGregory A. Poland, MD,director, vaccine research group, Mayo Clinic;Walter A. Orenstein, MD,professor andassociate director, Emory Vaccine Center; andAngela Rasmussen, PhD,virologist, Columbia University Mailman School of Public Health.
With new data from clinical trials about a COVID-19 vaccine being released every day, more concerns and more questions have been raised, especially by clinicians, said Mike Hennessy Jr., president and CEO of MJH Life Sciences, in a prepared statement. As the pandemic continues to surge, our mission to improve quality of life through health care communications, education and research has become more relevant and urgent than ever. Our teams are working hard and fast to ensure that the medical community has access to critical, timely insights to allay the confusion that exists within the medical and public community.
During the webinar, the panelists will provide insight on the following:
To learn more about the webinar and to register, click here.
REFERENCE
MJH Life Sciences Hosts Virology Experts for COVID-19: Race for a Vaccine Live Webinar [news release]. Cranbury, NJ; July 28, 2020: MJH Life Sciences. https://www.businesswire.com/news/home/20200728005629/en/MJH-Life-Sciences%E2%84%A2-Hosts-Virology-Experts-%E2%80%9CCOVID-19 Accessed July 29, 2020.
