The big question on the minds of most is, ‘when will a vaccine or treatment for Covid-19 arrive? When will life get back to normal? When can people go back to work without fear of life? When can we finally hug a friend with abandon?’
The quick answer is not in the immediate future, but University of Oxford-Jenner institute vaccine trail brings some promise with its preliminary results published in Lancet. 170 vaccines are now in development across the globe of which 15 are in human trial stage while Oxford-Jenner has published the results of its first and second phase in which 1077 healthy people between the age group of 18-55, participated.
Oxford-Jenner will soon be conducting trials in India as well.
Though a long way to go,the initial results have been “positive and promising”. Oxford University is using the common cold virus taken from chimps to stimulate the immune system. The first and second phase result of the vaccine has revealed that it is able to generate, “anti-body” and “T-cell” response in the body, something that defines a good vaccine.
Anti-body works like body guards that stop the infection from entering the body while the T cells fight it out when the infection has entered the cells. As far as the side-effects are concerned they are nothing major. These might be mild swelling in the arm where vaccine has been administered, slight headache and fever. All treatable by paracetamol.Results though have also revealed that for a 100% production of the desired anti-body and T-cells a booster dose might be required.
In a statement the institute said, “During the study participants who received the vaccine had detectable neutralising antibodies, which have been suggested by researchers as important for protection, and these responses were strongest after a booster dose, with 100% of participants blood having neutralising activity against the coronavirus. The next step in studying the vaccine is to confirm that it can effectively protect against SARS-CoV-2 infection.” Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the study said, “We saw the strongest immune response in the 10 participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”
Vaccine is overall safe and generates desired immune response. The next step is to find out the, “strength of the immune response required to fight the infection.”
“These encouraging results support further evaluation of this candidate vaccine in our ongoing large-scale Phase III programme, that is still needed to assess the ability of the vaccine to protect people from COVID-19,” said Professor Sarah Gilbert, Professor of Vaccinology, at the University of Oxford Jenner Institute and co-author of the study. While in the first and second phase the vaccine was given to 1077 participants between the age group of 18 and 55 years in a randomised controlled trial now in the third phase to 10,000 people. In the UK infection levels have gone down but vaccine can be best tested in places where infection levels are high so it’s being tested in Brazil and will soon be in India too for the trials. Dr. Sandy Douglas, an academic clinician, involved with the manufacturing side of the vaccine said, “we have plans of starting the clinical trials in India.” He was appreciative of the, “commitment and efficiency,” of the Serum Institute of India who they have collaborated with from the very beginning. Astra Zeneca, the British pharmaceutical giant responsible for the manufacture of the vaccinehas partnered with nine companies across the globe and committed to the production of 2billion doses once the vaccine is ready to be rolled out.“We are encouraged by the Phase I/II interim data showing AZD1222 was capable of generating a rapid antibody and T-cell response against SARS-CoV-2. While there is more work to be done, Oxford Jenner Vaccine plans to conduct part of their clinical trials in India too, as told today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world,” said Mene Pangalos, Executive Vice President of BioPharmaceuticals Research and Development at Astra Zeneca.
The answer that all are seeking is when will the vaccine be out? The Oxford -Jenner team did not put a figure on a month but did indicate that if all goes well then, an end of the year result could be expected. Even if that happens then the first in the queue will be the old and the vulnerable. UK is already committed to buying 190 million doses of different vaccines; these include 100 million doses of the Oxford vaccine; 30 millions of BioNtech/Pfizer vaccine and 60 millionof Valneva inactivated coronavirus
Imperial College Trial
Yet another trial that has shown some promise is the one going on in the Imperial College London. The Oxford and the Imperial teams have been in close contact with each other even though their approach to achieve the same result of boosting the immunity is different.
Imperial college is using the generic material from the virus itself to achieve the same result of helping the immune system in a person to fight the virus.It is based on synthetic strands of RNA, rather than a part of the virus. The final vaccine consists of RNA strands packaged inside tiny fat droplets. When injected, it instructs muscle cells to produce virus proteins. It does not create copies of the virus and does not cause changes to the cell’s own DNA. This protein can help kick in the immune response to fight the Covid-19 virus. Instead of using weakened or modified form of virus, like done traditionally the Imperial vaccine uses synthetic strands of genetic code (called RNA), based on the virus’s genetic material. If successful it will be an advance in the manner in which vaccine trials are conducted rather revolutionise vaccine development and enable scientists to respond more quickly to emerging diseases. It went onto human trial stage in June of this year, results are yet to be published.
A treatment that received approval is that of widely available mild steroid, dexamethasone being termed as a “major breakthrough” as it can reduce deaths due to Covid by 30%. While congratulating the “fantastic team of scientists right here in the U.K who conducted the first robust clinical trial anywhere in the world,” PM Boris Johnson said, “we have turned the tide but not beaten it yet.” Prof Martin Landray, the lead researcher of the trial in which 2,000 hospital patients were administered the drug explained that one in every 8 patients who was on ventilator could be saved while one in every 25 patients on oxygen showed positive signs of recovery. Dexamethasone though is not a complete treatment for all Covidpatients.
Dr. Amit Gupta, Clinical Lead, Neonatal Intensive Care Unit, Oxford University Hospitals said, “It is important to note that dexamethasone is of no benefit if the patient does not need oxygen and should not be used in this group.” Also, it’s worth noting that dexamethasone widely and commonly used for reducing inflammation thus useful in treating conditions such as rheumatoid arthritis, gut inflammation (ulcerative colitis) and allergies also has side effects. “The side effects include an increase in blood sugar (worsening of diabetes), weight gain and delayed wound healing. It is, therefore, used under strict supervision and only in specific conditions,” says Dr. Gupta.
Another treatment that needs trial
The University of Southampton and a UK biotech company, Synairgen conducted a study on 101 people during the period 30 March to 27 May 2020 that they claim can reduce hospitalisation of Covid-19 patients by 79%. It can be safely termed breakthrough if proven.The proposed treatment is like an inhalerstimulating the formulation of interferon beta protein which could reduce hospitalisation of COVID-19 patients that could stimulate an immune response leading to cutting down the odds of a covid-19 patient requiring hospitalization or ventilator by 79%. Also, there was significant reduction in breathlessness in patients on whom the treatment was administered.
Professor Stephen Holgate CBE, Medical Research Council Clinical Professor of Immunopharmacology at the University of Southampton and Co-Founder of Synairgen, said: “Recognising that SARS-CoV-2 is known to have evolved to evade the initial antiviral response of the lung, our inhaled treatment of giving high local concentrations of interferon beta, a naturally occurring antiviral protein, restores the lung’s ability to neutralise the virus, or any mutation of the virus or co-infection with another respiratory virus such as influenza or RSV, as could be encountered in the winter if there is a resurgence of COVID-19.”
“The double-blind placebo-controlled trial recruited 101 patients from 9 specialist hospital sites in the UK. Patient groups were evenly matched in terms of average age (56.5 years for placebo and 57.8 years for SNG001), comorbidities and average duration of COVID-19 symptoms prior to enrolment (9.8 days for placebo and 9.6 days for SNG001),” said Synairgen Richard Marsden, CEO of Synairgen, said: “We are all delighted with the trial results…This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in the treatment of hospitalised COVID-19 patients. Our efforts are now focused on working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible.” The company is yet to publish the full results and the trial would need to be expanded to wider population and tested for result.