According to the Ministry of Fisheries, Animal Husbandry and Dairying in Delhi,rows and ducks were reported dead in New Delhi and Sanjay lake areas tested positive.
In Death of crow confirmed in Kotdwar & Dehradun districts of Uttarakhand. In Delhi, crows and ducks, respectively, were reported dead in New Delhi and Sanjay lake areas.
By Dr Lalit Kant
World over the regulatory agencies are under intense pressure to grant approvals for the new Covid-19 vaccine(s). Several developed countries have indicated that if there is a compelling case for use of a vaccine before it qualifies for full license, they would be prepared to authorize emergency use approval on grounds of public health. The condition is that the balance of risk and benefit justifies temporary supply of the vaccine. A favourable benefit-risk determination can be made for vaccines that offer more than modest benefit or for those with sufficient data to assess safety profile.
An emergency use authorization (EUA) route is being adopted by many countries to facilitate availability of Covid-19 medicines and vaccine(s) to priority population groups. Though each country is free to adopt criterion for such an authorization, there are some guiding principles.
It is important to ensure that community gets safe and effective products expeditiously, and the testing and regulation must be fast tracked and rigorous. Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), regulators have been discussing COVID-19 vaccine development and the necessary evidence required for regulatory decision-making that meets the needs of regulators around the globe. This is critical for speeding-up and streamlining global development and authorisation of vaccines against COVID-19. In November 2020, ICMRA and the World Health Organization (WHO) committed to working together to ensure that patients have access to safe and effective medicines against COVID-19 as early as possible, while the existing rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times.
In late November 2020, the WHO finalized its ‘consideration for evaluation of Covid-19 vaccines’ that indicates both the process and the criteria that it will use to evaluate COVID-19 vaccines that are submitted either for prequalification (PQ) or for Emergency Use Listing (EUL). To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%. It also mentions that only vaccines that have undergone phase IIb or phase III studies and have been submitted to the National Regulatory Authority of record would be reviewed. It would also need data of adverse events of special interest, related or possibly related serious adverse events and medically attended adverse events after vaccination in all vaccinees with a minimum of 3 months, preferably up to 12 months, of follow-up after completion of administration of all doses in the vaccination schedule.
Let’s look at the processes adopted by the five countries which are amongst the firsts to give EUA to Covid-19 vaccines – the Lighthouse countries.
The US FDA in its October 2020 guidance entitled Emergency Use Authorization for Vaccines to Prevent COVID-19, explains that, for a COVID-19 vaccine among others, issuance of an EUA would require that the vaccine’s benefits outweigh its risks based on data from at least one well designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner. Further, at the time of the submission of the application the Phase 3 study should have already enrolled at least 3,000 vaccine recipients, and shown sufficient information to support a low-risk for vaccine-induced respiratory disease. To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%.
The European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency have adopted a similar approach.
While according Emergency Use Authorization to Covid-19 vaccines of Pfizer-BioNTech and Moderna the US FDA has followed this process and requirements. Similar is the case with UK’s MRHA while reviewing applications for Pfizer-BioNTech and AstraZaneca/Oxford vaccine.
China started work on Covid-19 vaccines in January 2020. A vaccine based on adenovirus delivery system was approved for limited use in June, 2020 on conclusion of Phase II trials. By end of November between 40 000 and 50 000 army men have been vaccinated by this vaccine. Two inactivated vaccines had been approved for limited use in China to vaccinate high risk groups (including healthcare workers) since July 2020, following encouraging results of Phase I and II clinical trials. Chinese regulators appear to be satisfied with the data of animal studies and the safety and immunogenicity data from Phase I and II trials. According to reports, hundreds of thousands of people in China have received these vaccines – healthcare workers, pandemic prevention personnel, border inspection personnel etc.
Russia had launched clinical trials on its adenovirus based Covid-19 vaccine in June, 2020. On 11th of August, Russia announced that its regulators have approved for limited roll out its Covid-19 vaccine, named Sputnik V. At the time when the Russian vaccine was approved by its national authorities, it had data for Phase I/II and none had been published.
In India, the Central Drug Standard Control Organization (CDSCO) is the apex regulatory authority to approve for public use medicines, diagnostics tests, devices, vaccines, etc. The New Drugs and Clinical Trials Rules, 2019, framed under the Drugs and Cosmetics Act, 1940, lists the multiple provisions to be followed for review and approvals of new drugs, clinical trials and vaccines. In these Rules there is also a provision to accelerate the approval of a new drug intended for use for diseases of special relevance to India or for filling an unmet medical need in India, especially for a disaster or special defence use. In such a situation, marketing approval could be granted based on Phase II clinical data if remarkable efficacy had been observed. The Rules provide a relaxation for skipping Phase III clinical trials if ‘remarkable efficacy’ is observed with a defined dose in the Phase II clinical trial of the new drug. The regulator can then also grant market approval for the new drug or vaccine based on Phase II data to meet what the Rules define as ‘unmet medical needs of serious and life- threatening diseases in the country’.
Like the bench mark set by World Health Organization and others, the Central Drugs Standard Control Organization (CDSCO) indicated in its draft ‘regulatory guidelines for vaccine development, with special consideration for covid-19 vaccine’ that “to ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%”.
In the first week of January 2021, based on the recommendations of the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) the DCGI accorded Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India (AstraZaneca/Oxford vaccine named Covishield) and Bharat Biotech (inactivated vaccine called Covaxin).
The SII vaccine had submitted the interim safety and immunogenicity data generated from trial in India and the data was found comparable with the data from the overseas clinical studies.
The SEC took cognizance of Bharat Biotech’s vaccine Phase I and Phase II clinical trials. It also noted that the Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, about 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data provided. The data on safety and immunogenicity of the vaccine was reviewed and SEC recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue. Based on these recommendations, the Drugs Controller General of India, accorded emergency use authorization, with conditions, to the two vaccines.
The WHO has developed a concept of Stringent Regulatory Authority (SRA) to guide medicine procurement decisions and is now recognized by the international regulatory and procurement community. Based on a laid down criteria the WHO considers regulatory authorities of 35 countries (as of November 2020) stringent. Meaning that these regulatory bodies are uncompromising. This is relevant to countries which do not have a regulatory authority or have a weak one, that they can adopt an approval given by one of the stringent regulatory authorities for a medicine (including vaccines) on the faith that it would have been well scrutinized.
The Russian, Chinese or the Indian regulatory authorities do not figure in the list.
The writer is Dr Lalit Kant ,Infectious Disease Epidemiologist.
According to the British media reports, nearly 46,000 NHS staff infected from the COVID-19 virus that will impact health services. The British Medical Association has appealed to start Healthcare workers vaccination by the end of this month.
“We must protect healthcare workers at a priority, they should get vaccinated till the end of this month.So, that we can be there for the patients,” said Dr.Chaand Nagpaul, Chair, British Medical Association(BMA)
PM Modi to meet Chief Ministers following the recent approval of two coronavirus vaccines for restricted emergency use in India.India to start vaccination from January 16 the date announced after PM Modi chaired a high-level meeting on Saturday.
The government has also announced about one crore healthcare workers and 2 core frontline workers will be the first to get inoculated. After the completion of Healthcare workers and Frontlines workers vaccination, next category is of those who are above 50 years of age and the under 50 year of age who comes under co-morbidities, together numbering 27 crores, according to the statement given by the government The center has already undertaken three rounds of nationwide dry runs regarding the preparation for vaccination. These dry runs was organised by the Central Union health ministry in coordination with States/UT’s before moving towards real-time vaccination.
India to start the ambitious adult vaccination from January16 the government announced on Saturday evening, hours after Prime Minister Narendra Modi chaired a high level meeting with senior officials to review the Covid situation in the country and finalise vaccine roll-out details in the country.
The Prime Minister called the news a “Landmark step forward in fighting COVID-19”.
Narendra Modi@narendramodiOn 16th January, India takes a landmark step forward in fighting COVID-19. Starting that day, India’s nation-wide vaccination drive begins. Priority will be given to our brave doctors, healthcare workers, frontline workers including Safai Karamcharis. https://pib.gov.in/PressReleseDetailm.aspx?PRID=1687305
Who will be in the Priority list for Vaccination?
One crore healthcare workers and Two core frontline staff – Doctors, Paramedical staff and Police personnel’s.The vaccine will be free of cost for these groups.Total three crore workers will be involved in Phase 1 vaccination drive.
Who will be in the next Priority list after Healthcare workers and frontline staff?
The next group will be people over 50 years of age, followed by those under 50 who comes under comorbidities and above 5Around 30 crore people will be vaccinated in this phase.
The airlift of the Covishield vaccine doses has been delayed more. It is expected to be done only by Monday. Before transportation of the vaccine, the agreement between the government and the company is expected to be done. The company has not confirmed yet the price of a COVISHIELD vaccine.
It was reported by some media that due to price negotiations with government transportation got delayed. But today Serum Institute of India’s CEO Adar Poonawala has clarified to the media and said that they are fully ready but waiting for a formal order, “The rollout will happen in a few days. There are due processes to be followed before we transport the vaccine doses.”
Bird flu is spreading in various States of India , it has been confirmed by the Ministry of Fisheries,Animal Husbandry &Dairying that bird flu has been reported in Kerala, Rajasthan, Madhya Pradesh, HP, Haryana, Gujarat and UP.But unusual death of birds have been reported from Chhattisgarh, Maharashtra and Delhi their sample results are pending.
The Indian Medical Association(IMA) has appreciated and lauded Indian Scientists and Researchers, after the approval of COVID-19 vaccines,“We, at Indian Medical Association, appreciate the contributions of all Indian Scientists and Researchers who have relentlessly spent their time in making this dream a success and contributing to develop Self-sufficient India.” said Dr J A Jayalal, President, IMA
During the press briefing, the Indian Medical Association(IMA) appealed to all the members of the association to actively participate in COVID19 Vaccination drive across the country that can start anytime after the official declaration.
“It is an immediate appeal to all members of this mighty association to actively participate in the Covid Vaccination drive across the country. Indian Medical Association, as the sole representative of modern medicine in India & the largest association in the world, shall rightfully assist the government vaccination drive in every possible way professionally. IMA Headquarters shall send timely details of the drive. Public awareness & countering the myths on social media must be on priority.”said Dr.Jayalal
The National Testing Agency (NTA) has written to the Ministry of Health regarding the dates of NEET 2021, The BDS aspirants are eagerly waiting for the National Testing Agency for the release of the time table for the entrance test. The aspirants are worried about the syllabus and examination pattern this year for the NEET 2021 .The last month NTA which is the exam conducting body for NEET was also planning to conduct NEET exam online mode twice a year.
The NEET , National Eligibility cum Entrance Test is a big competitive that conducted every year for MBBS and BDS courses across the country. This year NEET 2020, 13,66,945 students participated and over 15,97,435 students registered, but 2020 was very stressful for aspirants due to coronavirus pandemic. Many students are tweeting their request to the Education Minister Ramesh Pokhriyal Nishank to announce the date for the medical entrance exam test and hold the Exam twice a year.
The Apex Organisation of Chemists and Distributors of India (AIOCD) has written to Prime Minister Narender Modi regarding the inclusion of Pharmacists, Medicine Traders, Support Staff and Families for Covid-19 vaccination.The AIOCD has earlier also written letter to PM Modi and the Union Health Minister regarding this.
AIOCD is an Apex Organisation of Chemists and Distributors of India having aggregate over 8.5 lacks members, medicine professionals and trade (Retailers/Wholesalers/C&FA’s stock points).
“We are serving the nation in all adverse situations as per the promise given. Medicine dealers are in the essential service sector and have been most vulnerable to infection, as it’s a first contact point with the common public while dispensing medicines.” Said in a press statement
“We sincerely feel, it’s extremely important to protect all of them with priority , to keep the Chemist work force fit in challenging situations.”