The first peer-reviewed results of phase 3 human trials of the Oxford vaccine shows 70.4% efficacy.The results are based on data taken from 11,636 volunteers across the United Kingdom and Brazil.
The result shows no hospitalisations or severe disease in the vaccinated groups from three weeks after first dose.
The study has been published in the Lancet it is the first peer-reviewed publication of phase3 data from studies of a vaccine against the coronavirus.
According to the Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, “Today, we have published the interim analysis of the phase III trial and show that this new vaccine has a good safety record and efficacy against the coronavirus. We are hugely grateful to our trial volunteers for working with us over the past 8 months to bring us to this milestone.”
“The pooled analysis in the study shows that the overall vaccine efficacy at least 14 days after the second dose was 70.4%; the standard dose / standard dose sub-groups showing 62.1% efficacy, and with the low dose / standard dose sub-group demonstrating 90.0% efficacy. No hospitalisations or severe disease were observed in the vaccinated groups.” says the statement from the University of Oxford
“We have known for many years that adenoviral vectored vaccines fulfil the requirements for use against outbreak or pandemic diseases. They are safe, highly immunogenic, can be manufactured in large quantities at low cost and do not require frozen storage. Following the demonstration of vaccine efficacy in many preclinical studies, we now have clear evidence of efficacy in the trial results presented in a peer-reviewed publication today. Now under regulatory review, we hope that this vaccine will shortly be in use to start saving lives.” said Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford,
The Chief Executive Officer, Pascal Soriot, said “Today’s peer-reviewed publication enables a full disclosure of the Oxford program interim analysis. The results show that the vaccine is effective against COVID-19, with in particular no severe infections and no hospitalisations in the vaccine group, as well as safe and well tolerated. We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit.”
Co-WIN the new app will be available to downloaded free its a updated version of eVIN (Electronic vaccine intelligence network).This is the application which monitor the vaccination process from beginning to the end.
The details about the app you need to know
Co-WIN (Beneficiary Management Platform) that includes different modules.
Administrator Module – This is for the creation of the session, respective vaccinators and managers will be notified.
Registration Module – The registration module includes self-registration, bulk Upload, and registration by the surveyor.
Vaccination Module – The third module includes verifying all the beneficiary details and will update vaccination status.
Beneficiary Acknowledgement – The Beneficiary will also get an SMS alert after registration of Electronic vaccination certificate, QR based.
COVIN Dashboard – This module will provide reports on how many vaccinations have been done and how many have been dropout.
The app will also send real-time data about the temperature of cold storage.
“The database of health care workers from all the states, UTs and Central Ministries will be uploaded on CO-WIN software and all the data will be verified.” said Rajesh Bhushan, Secretary, Central health ministry
In an Exclusive interview, Pawanexh Kohli who is Former Chief Executive and advisor to India’s National Centre for Cold-chain Development(NCCD) , said that the biggest fear is that vaccine may prove ineffective against the future strain of virus.Therefore deployment of the vaccine should be extensive and expansive.
What would be the first step basic step involved to start Mass vaccination?
A mass vaccination exercise will require diligent planning and like all successful supply chain strategies, the basic step must be to first identify the destination points. Thereafter, after terminal inoculation centres are known, the strategy will be able to work backwards to distribution depots, to a regional store or the source manufacturer. The long haul from source to distribution depots will be planned as a bulk movement and from depot to inoculation centres in smaller tertiary shipper boxes. Each shipper box can carry 5 to 10,000 doses so that can be replenished every few days or weekly. The identifying of first recipients is just a diversion and efforts should be applied to identify vaccine givers and inoculation centres. In fact, the vaccine givers should be the first recipients, and they should receive their dose at least 2 weeks before they start inoculating the others in their zone.
How the distribution of a vaccine will be done to make the process smooth?
First concern will be to administer the vaccine in a socially distanced environment. A vaccine taker should not run the risk of picking up COVID19 even while waiting to receive the vaccine. Therefore, existing movie halls, restaurants, schools, convention halls should be designated as vaccination centres. Luckily they are all under occupied or empty, most already have cold rooms which can hold the vaccine at 2-8 °C for a couple of days.
Even railway coaches can be compartmented and quickly converted into inoculation centres, and a vaccine train can be deployed in each region – to service rural areas as it moves from village to village. Similarly, a group of vaccine buses can be used as mobile inoculation centres. The same infrastructure can be used at multiple locations.
A one way flow of people must be maintained and crowding must be avoided. Further, to ensure that a schedule is maintained, a ‘vaccine deposit’ can be refunded if the recipient will abide by the program. Another option is to offer a coronavirus insurance for a year if discipline of schedule is kept. Lastly, the actual distribution of the vaccine should be matched against return logistics of used syringes and vials from each location, to safely manage the medical waste that will be generated and as a double check avoid incorrect reporting.
Each vaccine taker should be marked with indelible ink, like is done after voting, and as a sign of social responsibility. Of course, Aadhaar linked digital records should also be kept.
What is the procedure to be followed for storing a vaccine?
Storage should only be to buffer the supply, with the agenda being to maintain a high throughput of vaccines. After all, the vaccines are not being made to be stored nut to be distributed. Any storage, in-situ or in transport, should be monitored for 3 parameters – for time & location though GPS, for temperature through data loggers, for excursions through thermos-chromic labels. The first would apply to the basic article of carriage, the second to tertiary packaging or individual boxes, and the last to individual vials. This will ensure a very high level of safety in the distribution network and mitigate risks. Usually any vaccine movement is monitored in a similar fashion, and in this case will probably require more close monitoring.
It will be imperative that the temperatures are maintained within the set parameters. Either within the range of 2 to 8 °C, or below -20 and/or below –70 °C depending on the vaccine. We must also keep in mind, that in cold climates, such as J&K these days, space may need to be heated to keep the temperature. So, it is not always refrigeration for cooling, but could also require heating. Data loggers will be important so that out-of-range parameters is flagged off and that batch can be discarded.
Another option is to store the vaccine in thermal shippers with passive cooling, and inside actively refrigerated space (like cold rooms and reefer trucks). A far higher level of redundancy will be in-built in case of cooling failure. This is not too dissimilar to ice-lined refrigerators, where the refrigeration system is buffered with the passive cooling system.
The Union Ministry of Health and Family Welfare Secretary, during the press briefing, has confirmed about starting a massive vaccine production after getting the green signal from Scientists.
“Once we get a green signal from our scientists, we’ll launch a massive production of the vaccine. We’ve made all the preparations & drawn an outline to ramp up production of vaccine & to make it available to each & every person in the shortest possible time.” Says Rajesh bhushan,Secretary, Health Ministry.
“Three vaccine candidates are under consideration of the regulator for licensing. Very active consideration is going on. There is hope that early licensure is possible in respect of all of them or any one of them.” said Dr VK Paul, Member (Health), NITI Aayog
The National expert group that was constituted by the Ministry of Health in August this year is providing all the guidance related to the prioritisation of population group, procurement, management, tracking mechanism, selection of a vaccine, and delivery.
“NEGVAC’s recommendation on prioritised population groups- healthcare providers & workers in healthcare setting, personnel from state & central police, armed forces, home guards,civil defence& disaster management volunteers&municipal workers & persons above 50 yrs.” Preparatory activities for the rollout of the vaccine being carried our by Central govt in collaboration with States and UTs.” Statement from Health Ministry
The database of health care workers from all the states, UTs and Central Ministries will be uploaded on CO-WIN software and all the data will be verified.
The cold chain for vaccination and its capability for storing COVID-19 vaccines is one of the biggest challenge, According to the statement given by the Ministry of health.
“The current cold chain is capable of storing an additional quantity of COVID19 vaccine required for first 3 crore health workers and front line workers.”
According to the reports from UK media a 90 yr old women becomes first one to get vaccine from Northern Ireland.She also becomes the first person in the World to receive the Pfizer/BioNTech Covid Vaccine. In first phase UK will vaccinate elderly people over 80s , health and care staff.
A 90 year old Ms Keenan felt privileged and its her birthday gift and now she will be able to spend time with her family,”I feel so privileged to be the first person vaccinated against Covid-19.”
According to the sources by PTI the Serum Institute of India(SII) vaccine maker company becomes the the vaccine maker company from India to seek emergency license for oxford COVISHIELD vaccine in India.
Pfizer seeks emergency use authorisation for its Covid-19 vaccine in India
Haryana government to promote Yoga in a state. Haryana Home Minister and AYUSH minister has announced by tweeting on Yogashalas in the state to 2000 and Yoga in a step to promote Yoga, Haryana Home Minister, and will be included as a subject in the education in Haryana.
The Haryana Yoga Council, in meeting it has been decided that the first Sunday of the month will be celebrated as a Yoga Day and more instructors will be recruited for yoga. The meeting was held in the presence of Chief Minister Manohar Lal Khattar in which Yoga Guru Ramdev was also present.