Covid-19 vaccine: Search, progress
Paper: III
For Prelims: covid 19 and process of developing vaccines.
For Mains: developing and different stage of trials of vaccines and different alternatives for vaccine.
Why in news:
A recent announcement by the University of Oxford that researchers there had started testing a vaccine against the novel coronavirus disease (Covid-19) has raised hopes. Over the last few weeks, there have also been somewhat conflicting reports about the performance of a drug candidate, remdesivir, while Israel has announced a breakthrough in another possible line of treatment, that with antibodies.
How do vaccines work?
- These are biological products that, when introduced in the body, teach the immune system to identify a disease-causing pathogen and store in memory which fightback options are the most effective.
- Some vaccines are live pathogens, whose ability to cause harm has been muted but whose essential identifying features have been retained so that the body can learn to recognize it.
What are the other therapy options besides vaccines?
- Various drug and therapy options are being tried around the world. Besides the global interest in the drug remdesivir, India has been talking about convalescant plasma therapy (in which the blood plasma of recovered Covid-19 patients, with antibodies, are transfused into the new patient); the Health Ministry has clarified it is a trial and not an approved treatment.
- Israel recently announced a “significant breakthrough” in development of monoclonal antibodies (those created from a single clone of cells) to treat Covid patients.
- Vaccines are important because a lot of resources are saved in preventing a disease and not having to treat it. Vaccines have been key to the elimination of once dreaded diseases such as smallpox.
- For Covid-19, a vaccine is of paramount importance at this stage. Until an effective treatment emerges, there are only two possible courses ahead: Either communities develop herd immunity (a painful process involving high rates of infections and deaths), or a vaccine is made available around the world at affordable costs.
What is the new vaccine for which tests have been announced?
- It was originally intended for another coronavirus — the one that causes MERS. It has been developed at the Jenner Institute and named ChAdOx1 nCoV-19.
- In a statement issued on April 23, the University of Oxford said: “ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans. Genetic material has been added to the ChAdOx1 construct, that is used to make proteins from the COVID-19 virus (SARS-CoV-2) called Spike glycoprotein (S). This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus. The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to gain entry to the cells and cause an infection.”
- The idea is to teach the body to recognize the spike protein of the virus by first exposing it to ChAdOx1 to-19. Thus when SARS-CoV2 enters the body, an immune response is mounted based on that recognition. “Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well-tolerated, although they can cause temporary side effects, such as temperature, headache or sore arm,” the statement added.
- There is also an India connection to the vaccine. The Serum Institute of India, one of the largest vaccine manufacturers in the world, is a partner for the production of the vaccine in preparation for the trials. In a statement, the company has said: “SII will be manufacturing the vaccine in anticipation of clinical trials succeeding by September-October in the UK. The vaccine will not be made available to the public in two-three weeks, as suggested in some media reports. Following that, SII has undertaken the decision to initiate the manufacture at their own risk. The decision has been solely taken to have a jump start on manufacturing, to have enough doses available, if the clinical trials work.”
What is the progress of trials?
- The vaccine leapt straight to human trials for testing of efficacy because the safety had already been proven earlier when it was being developed as an option against MERS.
- For the trial, 1,102 participants will be enrolled across Oxford, Southampton, London and Bristol. They will be split into the vaccine arm and the control arm; the control will not be a placebo as is usually done, but another vaccine. This will be MenACWY, a vaccine licenced for use against a common bacteria that causes meningitis and sepsis.
- This is being done because ChAdOx1 nCoV-19 causes some side-effects such as headache and fever. Using a placebo such as saline control would not produce those same side-effects, thus the subject would know what he or she had received. “If participants were to receive only this vaccine or saline control, and went on to develop side effects, they would be aware that they had received the new vaccine. It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study,” reads the Oxford statement.
UNITED STATES: On March 16, the day the first participant was enrolled in the trial for the Moderna vaccine candidate, the NIH said in a statement: “A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (Covid-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial… The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today.” The trial is looking at the safety of the vaccine and its efficiency in actually generating an immune response.
According to a current report filed by Moderna with the US Securities and Exchange Commission, a “… the commercially-available vaccine is not likely to be available for at least 12-18 months, it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.”
HONG KONG: Another candidate vaccine is being tested by Hong Kong-listed biotech firm CanSino Biologics. Having started after the NIH trials, the company last week announced that phase I trials have been cleared and the vaccine is moving into phase II of the trial “based on the preliminary safety data of the Phase I clinical trial”. The results of that trial have not been made public.
Way Forward:
Like the Oxford vaccine, this too is an adenovirus-based vaccine. The double-blind, placebo-controlled study in 500 healthy patients will be done in association with researchers form the Academy of Military Medical Sciences’ Institute of Biotechnology. By some estimates, over 40 vaccine candidates are in various stages of development around the world. Until the Oxford announcement, one of the most promising candidates was believed to be one developed by Moderna, a biotechnology company, that is now into phase I clinical trials under the aegis of the US National Institutes of Health (NIH).
Hacker ‘sees’ security flaws in Aarogya Setu
Paper: III
For Prelims: Aarogya Setu App.
For Mains: Data security and privacy issues.
Why in news:
Ethical hacker Robert Baptiste on May 6 alleged that security flaws in the government’s Aarogya Setu application enabled him to see that five people at the Prime Minister’s Office (PMO) and two people at the Indian Army headquarters were unwell.
Important facts:
- Baptise, who goes by Elliot Alderson on Twitter, also claimed that there was “one infected person at the Indian Parliament and three at the Home office.”
- On May 5, he tweeted that there were security issues with Aarogya Setu. Tagging the official account of Aarogya Setu, he said, “A security issue has been found in your app. The privacy of 90 million Indians is at stake. Can you contact me in private?”.
- He went on to add that former Congress president Rahul Gandhi, who has termed the app “a sophisticated surveillance system”, was right.
- In response to the issues raised by Mr. Baptise, the team of Aarogya Setu, in a statement, said no personal information of any user had been proven to be at risk. we were alerted by an ethical hacker of a potential security issue of Aarogya Setu…No personal information of any user has been proven to be at risk by this ethical hacker. We are continuously testing and upgrading our systems. Team Aarogya Setu assures everyone that no data or security breach has been identified,” the statement said.
- Following this statement, Mr. Baptise tweeted that he was able to “… know who is infected, unwell, made a self assessment in the area of his choice. Basically, I was able to see if someone was sick at the PMO office or the Indian parliament. I was able to see if someone was sick in a specific house if I wanted… This is the issue.”
- He further called for making the application’s source code open source. “…When you ask (force) people to install an app, they have the right to know what the app is really doing. If you love your country @SetuAarogya, publish the source code,” he tweeted, adding that countries such as Singapore, Israel did it and Iceland did it.
- As per the Aarogya Setu statement, Mr. Baptise pointed out that the application fetched user location on a few occasions. However, Aarogya Setu said, “This is by design and is clearly detailed in the privacy policy.”
- It noted that the application fetched a user’s location and stored it on a server in a secure, encrypted and anonymised manner “1) at the time of registration, 2) at the time of self-assessment, and 3) when the user submits his or her contact tracing data voluntarily through the app or when we fetch the contact tracing data after the person turns COVID-19 positive.”
- Further, the French hacker had said that a user can get the COVID-19 stats displayed on the home screen by changing the radius and latitude-longitude using a script.
- The Aarogya Setu statement said, “The radius parameters are fixed and can only take one of the five values — 500 metres, 1 km, 2km, 5km and 10km. These values are standard parameters, posted with HTTP headers. Any other value as part of the ‘distance’ HTTP header gets defaulted to 1 km.”
- It added that a user can change the latitude/longitude to get the data for multiple locations. “The API call though is behind a Web Application Firewall, and hence bulk calls are not possible. Getting data for multiple latitude longitude this way is no different than asking several people of their location’s COVID-19 statistics. All this information is already public for all locations and hence does not compromise on any personal or sensitive data.”
About Aarogya Setu App:
- The ‘Aarogya Setu’ tracking app will help track the corona virus infection by using the smartphone’s GPS system and Bluetooth and provide information that will help in determining if you have been near a Covid-19 infected person or not.
- The Aarogya Setu app supports 11 languages and this app has been developed by the National Informatics Centre that comes under the Ministry of Electronics and Information Technology.
- This application determines if you are at risk by scanning through a database of known cases across India, and also via location.
- Ensuring the data is encrypted, the app uses your location to know of the area you are around comes under the infected areas of the database and also needs an activated Bluetooth to determine if you have been within six feet from the infected person.
- The app will share your data with the government in case you test positive for Covid-19 or if you came in contact with the covid-19 positive patient.
- The app’s privacy policy mentions that it does not share data with other third-party apps. Your data is shared only with the government. The app does not allow your name or number to be disclosed to the public at any time.
- The chatbot in the app can answer basic queries and help you check symptoms. It also gives you state-specific helpline numbers.
Reasons for Launching this app:
- Creating Awareness:
- With the launch of this app, the governments seeks to limit the spread of the Covid-19 cases in India via technology and AI as well as, help create self awareness among the citizens with relevant information on the infection. Currently, according to health ministry, the numbers of confirmed Covid-19 cases have surged to 1965.
- Reducing pressure of Health workers:
- With the basic aim of increasing awareness among people related to pandemic and ways of protecting oneself, it will reduce huge burden of government and health service providers by creating self assessment zone for health safety of people.
Importance of Raising Awareness in fight against Corona Virus:
- Increasing vigorous awareness-raising campaign to educate the general public about the virus and the necessary precautions should be exercised to prevent a further increase in infections.
- Consideration of the nature of the human to human transmission method of the virus, majority of the mentioned awareness-raising activities has been implemented in accordance with a strict no-contact policy. As such, verified information disseminated through social media platforms too has succeeded in reaching a large audience which will be catalyst in fight against corona virus.