First detected in December in Wuhan, China, COVID-19 has now become a pandemic affecting almost 1.5 million people worldwide and causing more than 80,000 deaths at the time of writing. According to the World Health Organization’s emergency expert, even measures like complete lock-down of cities and societies are not enough to whitewash COVID-19. We need to put proper public health measures in place to detect and isolate the patients from rest of the people. When that’s done, it is the virus that need to be tackled. As the COVID-19 cases have hit a steep exponential growth, all eyes are on the healthcare companies, researchers and academic institutions which are tirelessly working towards definitive treatments and vaccines.
Majority of the people infected with the COVID-19 display only minor symptoms including fever, cough, and runny nose. In the severe cases, the virus can cause Pneumonia in both lungs and organ failure, ultimately resulting in death. The treatments being trailed fall majorly into two categories:
1. Treating respiratory symptoms– particularly the inflammation that occurs in the lungs
2. Antiviral growth– stopping viruses from replicating inside the human body
Antiviral measures target the virus inside the infected people. They work by preventing the virus from replicating, or blocking the virus from infecting the human cells. Development and approval of antivirals take less time than vaccines.
Since creating a new drug involves heavy research and time, existing drugs are also being considered for antivirals. For example:
1. Chloroquine - Initial laboratory studies show that the antimalarial drug may work against the COVID-19 virus by blocking infection. A small clinical trial in France hinted that it may work as a treatment for COVID-19. However, the study wasn’t randomized, so they will need larger clinical trials. However, the drug, along with hydroxychloroquine, was granted emergency use designation by the US FDA.
2. Favipiravir - This drug is approved in countries outside the United States to treat influenza. Reports from China suggest it may work as a treatment for COVID-19.
3. Remdesivir - This 10-year-old drug failed the clinical trials against Ebola in 2014. But it was found to be safe in people. Research with MERS showed that the drug blocked the replication of virus. It is being tested in five COVID-19 clinical trials. The first results should be available in April.
4. Ritonavir - Already approved for the treatment of HIV infection, lopinavir is being studied along with ritonavir for the treatment of MERS and SARS coronaviruses. Vitro studies revealed that lopinavir/ritonavir has sufficient antiviral activity against SARS-CoV-2. The drug is currently in phase 4 of clinical trials to investigate whether lopinavir/ritonavir reduces viral load from respiratory specimen.
5. Actemra - Undergoing clinical trial in China, Actemra prevents overreaction of the immune system, hence reducing the chances of organ failure leading to death in some coronavirus patients.
6. Remdesivir (GS-5734) - An ineffective Ebola drug developed by Gilead Sciences is being tested in two phase III randomized clinical trials in Asian countries including Japan and China.
Vaccines and Clinical Trials
A vaccine stimulates the body’s immune system to fight against infectious pathogens, like bacteria and viruses. They are one of the most effective ways to prevent diseases. A vaccine protects people before exposure to a virus — in this case, SARS-CoV-2, the virus that causes COVID-19. A vaccine trains the immune system so that it recognizes and attacks the virus when it comes to face with it. Vaccines are important because they protect the vaccinated person and the society. A vaccinated person stops further infection by fighting the virus inside his body. This stops further spread of the virus. This is termed as herd immunity. Though vaccines are the best way to end this pandemic but the time it takes from development of a vaccine to the vaccine being available for sale is at least 18 months. For a medicine/vaccine to be sold it needs to go through the standard process of clinical trials including phase 1 to 3 trials. The process ensures that the medicine is safe, harmless, is effective. The process can be broken down into six phases: 1. Vaccine design: Scientists study a pathogen and decide on how they will get the immune system to recognize it.
2. Animal studies: Animals are tested against the vaccines. This is done to show that it works and has no extreme adverse effects.
3. Clinical trials (phase I): Small number of healthy people and infected people are given the drug. This identifies any side effects and determines the dosage of the drug.
4. Clinical trials (phase II): The drug or vaccine is given to a large group of infected people. A coronavirus trial may assess if a vaccine stimulates the immune system in a certain way and no side effects from phase 1 show up.
5. Clinical trials (phase III): The final phase of trials sees an even greater amount of people tested over a long period of time.
6. Regulatory approval: The final hurdle sees regulatory agencies, like the US Food and Drug Administration, the European Medicines Agency and Australia’s Therapeutic Goods Administration which take a look at the available evidence from experiments and trials and conclude whether a vaccine should be given the all-clear as a treatment option.
Companies are working on potential vaccines for SARS-CoV-2, with several backed by the nonprofit Coalition for Epidemic Preparedness Innovations (CEPI). The work was started after Chinese scientists shared the genetic sequence of the virus. The key companies include:
1. Moderna - Moderna, with extreme urgency, has begun testing its messenger RNA (mRNA) vaccine, mRNA-1273, in a phase I clinical trial in Seattle, Washington. The study includes 45 healthy volunteers, ages 18 to 55. The company is known for developing other mRNA vaccines before. The earlier vaccines and studies were safe enough, allowing the company to skip certain animal testing for this specific vaccine. Within the trial patients will receive two injections of the mRNA-1273 28 days apart. The 45 patients will be divided into three groups of 15 and given differing doses: 25 micrograms, 100 micrograms or 250 micrograms.
2. CanSino Biological - Accredited with success in developing the Ebola virus vaccine, it is proceeding with the phase I clinical trial for its Non-Replicating Viral Vector based vaccine Ad5-nCoV.
3. BioNTech SE and Pfizer - Pfizer has agreed to help develop and distribute BioNTech SE’s COVID-19 vaccine candidate. BioNTech plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. It is testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China.
4. University of Oxford - ChAdOx1 nCoV-19 developed by the University of Oxford is an adenovirus vaccine vector. The vaccine is being tested in a clinical trial in the Thames Valley Region with approximately 510 volunteers aged between 18 years and 55 years.
5. UMC Utrecht and Radboud University - A collaboration of research institutes and universities is testing Bacillus Calmette-Guérin (BCG), a vaccine against tuberculosis, in phase 3 of the clinical trial. This is based on the fact that BCG reduces the incidence of respiratory tract infections in children. It is a placebo-controlled trial wherein a group of subjects receives the treatment to be evaluated and a separate control group receives a placebo treatment having no real effect.
At least 41 companies and research institutes are hustling for a vaccine which can bring the pandemic to end. Even if the vaccines are proven to be safe and effective in protection against COVID-19, they could still be at least a year away and probably more.