Coronavirus vaccine / drugsApprox Read Time: 6 minutes
In News: Coronavirus vaccine
- Scientists are at work around the world for development of vaccines and therapeutics.
How soon can a drug or a vaccine be expected?
- According to WHO, if everything goes really well, the vaccine development would probably take the next 12-18 months but even after that it may take 18-24 months to make the sufficient doses available.
- First-line treatment: The initial treatment is referred to as first-line treatment or first-line therapy. This treatment is usually what worked best in clinical trials for people with the same type of disease.
- Second-Line treatment: If the first-line treatment did not work, or may start but then stop working, or may cause serious side effects. Then the doctor may then suggest a second-line treatment, also called second-line therapy. It is a different treatment that is likely to be effective.
- Third-Line treatment: Depending on the type of disease and the available drugs, there may also be a third-line therapy or additional rounds of treatment after that.
Process of Drug and vaccine development:
- Drug and vaccine development are an elaborate process. Zeroing in on a candidate drug or vaccine may take years.
- The safety and efficacy of drugs and vaccines have to be tested over three phases as per protocols. Once a new drug has passed testing in animals, clinical trials kick in.
- A fourth stage involves collection and analysis of post-marketing data.
Development of COVID-19 vaccine:
- The vaccine development work is being carried on the already work done on the SARS and MERS vaccines (as it belongs to the same family).
- On the vaccines it may be at least six months before the first data starts coming in as there is always a probability that it will not be a success also.
- The researchers are working to evaluate the data on efficacy of existing antivirals and how these can be improved upon.
- The World Health Organization (WHO) has announced SOLIDARITY.
- Solidarity is a multi-arm, multi-country clinical trial to look for the best treatment against COVID-19.
- It will test the antiviral drug Remdesivir; a combination of HIV drugs Lopinavir and Ritonavir; Lopinavir and Ritonavir + interferon beta; and the antimalarial drug chloroquine.
- So far Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland, and Thailand have signed up.
- It is the most promising trial under the aegis of the US National Institutes of Health (NIH).
- Trials have begun on adult patients with COVID-19 hospitalized at the University of Nebraska Medical Center.
- Remdesivir, has been developed by Gilead Sciences Inc.
- It was previously tested in humans with Ebola virus disease and has also shown promise against MERS and SARS.
About: LOPINAVIR + RITONAVIR
- These are a combination of second-line HIV drugs and people have recovered without antivirals.
- Around the world, lopinavir-ritonavir combination trials are on under way.
- Chinese researchers have reported a mortality of 22% in severely ill patients who had been administered the lopinavir-ritonavir combination, higher than the 11% to 14.5% mortality reported in initial descriptive studies.
- Thus, no benefit was observed with lopinavir–ritonavir treatment beyond standard care.
- An ongoing study is being conducted in China on using the lopinavir-ritonavir combination along with chloroquine.
- The drugs are being administered to eligible patients between February 12 and May 31.
- Earlier studies have shown that chloroquine can inhibit coronavirus replication through multiple mechanisms.
- The previous use of chloroquine to treat patients with SARS-CoV-2 (novel coronavirus)-infected pneumonia has a higher negative rate of nucleic acid in throat swabs within 5 days after administration than that using lopinavir/ritonavir.
- This is a drug used in Japan to treat new strains of influenza.
- It has been developed by a subsidiary of Fujifilm.
- According to China’s science and technology authorities the drug appeared to be effective in coronavirus patients.
- Patients given the medicine were reported to have turned negative after a median of four days, compared with a median of 11 days for those not given the drug.
About: NEW POSSIBILITIES:
- Efforts are also on to develop a drug from scratch.
- The researchers are identifying proteins inside the cell that the virus uses to set its replication machinery rolling.
- They are now exploring if targeting any of these proteins would halt the replication of the virus.
Progress on vaccine development:
- In U.S:
- The vaccine, mRNA-1273, was developed by NIAID scientists and collaborators at the biotech company Moderna.
- A Phase 1 clinical trial has begun in Seattle, funded by the National Institute of Allergy and Infectious Diseases (NIAID).
- The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks.
- The first participant has already received the investigational vaccine.
- In China:
- Scientists in China are exploring options such as using the virus minus its potent elements, or using other attenuated (rendered harmless) vaccines, to introduce the virus into the body to generate a natural immune response against an actual infection.
- They have received approval for vaccine trails.
Use of Lopinavir/Ritonavir in India: Coronavirus vaccine
- The government has revised its clinical management guidelines for COVID-19:
- The use of Lopinavir/ Ritonavir in PEP regimens for HIV (4 weeks) is also associated with significant adverse events which many a times leads to discontinuation of therapy.
- In light of the above, Lopinavir/ Ritonavir should only be used with proper informed expressed consent on a case to case basis for severe cases, within the under-mentioned framework along with supportive treatment as per need.
- The combination is to be used in patients who have hypoxia, hypotension, new onset organ dysfunction (one or more) and also in certain “high risk groups”.