You can’t rush the science, but when the science points you in the right direction, then you can start rushing. ~Anthony Fauci
It seems like a lifetime ago, but I started covering the Covid-19 pandemic in Issue 29 on February 7. That was the same day that Trump told reporters that the CDC is working with China on the coronavirus. In the interim, I’ve covered advances in testing for and treating Covid-19, and other technologies poised to help us survive this pandemic. It seems like a good time to cover advances in the search for a vaccine.
In this issue, I’ll summarize the current state of vaccine research, what clinical trials are all about, when we might have an approved vaccine, and how we might distribute it to millions of people.
Coronavirus vaccines: Where are we now?
There are more than 100 projects around the world developing a COVID-19 vaccine. Some approaches have been used before to create vaccines, but some are new. There are basically three approaches to developing vaccines:
- Live vaccines use a weakened (attenuated) form of the virus. Measles, mumps, rubella, smallpox, and chickenpox vaccines are examples. The infrastructure is in place to develop these kinds of vaccines, but they require extensive safety testing.
- Inactivated vaccines use a killed (inactive) version of the virus. Inactivated vaccines are used to prevent the flu, hepatitis A and rabies. This type often requires multiple doses, followed by booster doses, to provide long-term immunity.
- Genetically engineered vaccines use RNA or DNA that has instructions for making copies of the S protein (these protein spikes create the corona-like, or crown-like, appearance that gives the viruses their name). These copies prompt an immune response to the virus. No infectious virus needs to be handled, but this type has not been licensed for human use.
Good News: Eight candidate vaccines are being tested in clinical trials in people.
- Moderna messenger RNA (mRNA) vaccine: The vaccine had produced antibodies in all 45 trial participants in the initial clinical phase. Phase III clinical trials start in July.
- Inovio DNA vaccine: They had a head start with their DNA vaccine for MERS. Phase II/III clinical trials start this summer.
- University of Oxford / AstraZeneca modified virus: A clinical trial with more than 500 participants began in late April. Oxford officials said the potential vaccine has an 80 percent chance for success and said in mid-May that if the clinical trial is successful, they could deliver 30 million doses by September.
- Imperial College London RNA vaccine: A trial involving 6,000 people is expected to go ahead in October.
- University of Queensland in Australia attenuated virus: The phase I trial in people will begin in early July.
- Pharmaceutical companies. Johnson & Johnson and Sanofi are both working on a vaccine of their own. Pfizer has also teamed up with German biotech company BioNTech to develop a vaccine. They began human testing in the United States in early May.
How Long Will a Vaccine Really Take?
Back in March, Dr. Fauci told reporters a vaccine for public use likely won’t be ready for another 12 to 18 months.
The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. Clinical trials almost never succeed. We’ve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.
Good News: Vaccine development can take years. In fact if we were starting from scratch, we might not have a safe vaccine until 2036!
Fortunately, we aren’t starting from scratch since past research on SARS and MERS vaccines have identified potential approaches. In this all-hands-on-deck approach, the US plans to shorten the time frame by starting trials early, not waiting for academic research, starting subsequent steps before previous steps are completed, push to large scale testing sooner, vaccinate front-line and essential workers sooner, build out manufacturing early, and fast-track federal approvals.
Once a coronavirus vaccine exists, this mailable patch could deliver it to millions
Even when a vaccine is ready, another enormous hurdle is the ability to deliver that vaccine to millions or even billions of people. Typically, a vaccine is administered by injection (intramuscular, intradermal, subcutaneous), and has to be refrigerated and administered by a medical professional. Can you imagine the expense and logistics of that process?
Fortunately, Guizhi “Julian” Zhu, Ph.D., an assistant professor in the School of Pharmacy’s Department of Pharmaceutics at the Virginia Commonwealth University has a better way, a unique patch.
Good News: Dermal or skin patches have been around for years to administer drugs that include pain relievers, nicotine, hormones, and drugs to treat angina and motion sickness. However, those patches won’t work with a vaccine. Instead, this design uses more than a hundred polymer microneedles — each as thin as a human hair — on each patch to get through the skin to dispense the vaccine.
Someday, hundreds of millions of vaccinations against the coronavirus that causes COVID-19 could show up in people’s mailboxes and be applied as simply as slapping on a Band-Aid. … People, no matter who they are, can apply the patch to their own arm,” Zhu said. “And that’s it. People are vaccinated.
Our lives won’t approach the old normal until there is a proven treatment or vaccine. There are numerous treatment approaches including anti-virals, monoclonal antibodies, convalescent plasma, immune modulators, and stem cells.
But the best approach would be to protect people before they are exposed, using a vaccine. Instead of waiting for a decade or more for a vaccine, I’m optimistic that we will have one much sooner, perhaps the mRNA vaccine by Moderna or the Oxford vaccine. They announced that their coronavirus vaccine could be ready for emergency use by September if trials prove successful.
Dr. Rod Murray
To help me keep this newsletter ad-free, support me if you can: