Covid-19 has sparked the fastest vaccine-development process in history and several, as described below, initiatives are already underway. The race started in January when Chinese scientists published the complete 30,000-letter genetic code of SARS-CoV-2, the virus that causes Covid-19. Scientists could then make synthetic versions of the virus instead of waiting for a sample.
In the U.S., considerable resources, financial as well as personnel, are being used to develop a vaccine to the coronavirus. Hopefully we’ll see a vaccine earlier than before, much thanks to research that has previously been done on other coronaviruses such as the Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).
Here’s is an overview of the ongoing initiatives from both the American government organizations and industry to fight Covid-19 and for the U.S. to become the first country that produce a vaccine – a battle that America does not want to lose.
FDA – The U.S. Food and Drug Administration
The FDA is responsible for protecting and promoting public health in the U.S. through the control and supervision of pharmaceutical drugs (medications) and vaccines etc. In a recent analysis, the FDA currently administrates 65 vaccine and therapeutic candidates related to Covid-19. They have also produced a guide that is intended to facilitate and speed up the development of a vaccine. A majority of the clinical trials that are initiated are normally not going to be approved by the FDA. According to a study conducted by the Biotechnology Innovation Organization (BIO), 16.2 % of the vaccines that start being tested in Phase 1 are eventually approved. Other studies suggest that the number is 31.6 percent.
Federal Research and Development
In Seattle, a Phase 1 clinical trial with the intent of finding a vaccine has been initiated. This trial includes 45 healthy adult volunteers whose immune system will be tested after different doses of an investigational vaccine. It’s called mRNA-1273 and has been developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) in Cambridge, Massachusetts, and their collaborators. mRNA-1273 is using the genetic platform mRNA, which enables the vaccine to direct the body’s cells to express a virus protein and thereby elicit a response by the immune system. As mentioned above, the quick development of mRNA-1273 was possible because of Covid-19 similarity with other coronaviruses such as SARS and MERS.
Another promising test by scientists at University of Pittsburgh School of Medicine was published in an article on April 2nd in eBioMedicine – The Lancet. The vaccine is called PittCoVacc and, compared to the abovementioned mRNA vaccine now being tested in Seattle, follows a more established approach focusing on the spike-protein. It has some resemblance with existing flu vaccines. The scientists are however using a unique method in the delivery of the drug, called microneedle array. This method is supposed to increase potency and works through a fingertip-sized patch of 400 microneedles that delivers the vaccine into the body.
A more immediate and short term solution and while the world awaits a vaccine, scientists at Johns Hopkins Bloomberg School of Public Health has published a study about the use of antibodies (plasma) from recovered Covid-19 patients. This plasma is not a vaccine but can be used to give people immunity and has already started being used in China – that in turn sent 90 tons of plasma to Italy. On March 18th, a request for approval was submitted to the FDA. On March 23rd, FDA announced the approval of this method in at least two hospitals in New York City; Mount Sinai and Albert Einstein College of Medicine. Several academic medical centres in the U.S. will now perform clinical studies to thoroughly investigate the method.
Another possible solution, announced April 10th, is to investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19. It is the drugmaker Eli Lilly that will, beginning this month, starts the tests in the U.S. with a planned expansion to additional sites including Europe and Asia. Results are expected within the next two months.
National Institutes of Health (NIH)
The NIH is financing a project that have succeeded in creating an atomic-scale map over the CoV spike glycoprotein – the part of the SARS-CoV-2 that causes Covid-19 and therefore is a key target for vaccines, therapeutic antibodies, and diagnostics. The result was published here in mid-February. Vaccine against this spike-protein is now being tested on mice at NIHs Vaccine Research Center (VRC). The first phase of clinical studies on human will soon be commenced.
The National Institute of Allergy and Infectious Diseases (NIAID) – part of NIH – has compiled information about several of their projects connected to Covid-19. You find them here. Other relevant NIH-links are:
Industrial Research and Development
The American pharmaceutical giant Johnson & Johnson (J&J) also jumped into the race and started developing a vaccine in January, and has teamed up with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Department of Health and Human services. J&J and BARDA have together committed to invest more than 1$ billion in the project, with the goal that the same number of doses of vaccine will be provided globally. J&J strives to test the vaccine on humans in September and having the first batches of the vaccine available for emergency use authorization in early 2021.
Another American company working on a vaccine against Covid-19 is Gilead Sciences Inc. They are since before developing remdesivir – an investigational broad-spectrum antiviral treatment. Remdesivir also has been investigated as a treatment for the Ebola virus disease and, in addition, shown positive results on animals infected with MERS. Because of its long-gone development remdesivir is now used in a Phase 3 trial – where persons hospitalized by Covid-19 will take part in a placebo-controlled study.
Another player is Inovio, an American company with earlier experience of being in Phase 2 of the development of MERS vaccine, are now initiating Phase 1 with trials on humans first in the U.S. and thereafter in China and South Korea. They are developing a DNA vaccine and together with Ology Bioservices they recently (March 24th) received $11.4 million in monetary support from the Department of Defence.
Except for the above-mentioned companies, a mix of legacy drugmakers and small startups have stepped forward with a plan to develop a novel vaccine. Here is an interesting list of 19 American companies that are now targeting the infection and where they are in the development process.
To help adress the challenge, researchers from the leading AI institutes, including Allen Institute for AI and Microsoft, and the federal government agency (i.e., the National Library of Medicine) have teamed together to support and accelerate research. They have developed a dataset – the Covid-19 Open Research Dataset (CORD-19). It has collected more than 24 000 articles from peer-reviewed journals and other sources such as bioRxic and medRxiv. The dataset is a result of the demand from the White House Office of Science and Technology Policy (OSTP) and will be updated as soon as new research is published. In conjunction with this a competition for AI researchers has been issued – the Covid-19 Open Research Dataset Challenge – with the support from the Kaggle platform.
As the current situation is developing, we will update you with more information on how scientists in the U.S. work to fight Covid-19. In the meantime – the Office of Science and Innovation in China has also written posts on Covid-19, read an early overview, how it affects environmental safety or where we can see light in the darkness. Here you can also read about how South Korea is affected by the virus. And as always – stay safe and follow your country’s guidelines.
In Europe, the European Commission has since the outbreak been supporting research and launced several special actions. Here you find a number of research and innovation projects and initiatives to tackle the spread of coronavirus and preparedness for other outbreaks.
Counselor Henric Johnson and intern Nora Myrne Widfors
Office of Science and Innovation in Washington D.C.