News Analysis India

Tag: COVID 19 Pandemic

  • Different Oxford jab dosing for tests and actual rollout in India

    Express News Service
    NEW DELHI: A day after the drug regulator greenlighted Covishield, a vaccine against Covid-19 produced by Serum Institute of India that could be the mainstay of the country’s immunisation drive at least initially, it emerged that the approval was for a dosing regimen that has not been tested in India so far.

    In phase 2 and 3 trial design of the vaccine, originally developed by AstraZeneca-Oxford University, two doses were given 28 days or four weeks apart in India. But the regulator accorded permission for the second dose to be administered 4-12 weeks apart in its letter to the company.

    Covishield and Bharat Biotech’s Covaxin were granted restricted emergency use (REU) authorisation in India on Sunday.

    ALSO READ: Covaxin being targeted because it’s made by Indian company, says Bharat Biotech MD

    “The second dose should be administered between 4 to 6 weeks after the first dose,” the Drug Controller General of India’s letter said.

    “However there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies,” the letter added.

    Experts pointed out that by allowing duration flexibility of up to 12 weeks, the regulator just followed the UK permission model to AstraZeneca’s vaccine.

    “Clearly, a lot of rules have been relaxed in granting the REU to the vaccine and this may also be one of them,” said an ICMR scientist who did not wish to be named.

    ALSO READ: Herculean efforts paid off, Health Minister Vardhan to scientists on COVID-19 vaccine approval 

    “Normally, vaccines or drugs are approved under the same dosing schedule under which they have been tested in the country.”

    In the UK, the regulators decided to give the Oxford vaccine to people as one shot, followed by another up to 12 weeks later to extend protection to as many people as possible. But experts questioned the decision since there isn’t sufficient evidence to extend the time between injections to 12 weeks.

    In India, SII presented to the regulator only the immunogenicity data from 185 of the proposed 400 volunteers as part of its phase 2 trial and no efficacy data from phase 3 trial, as per publicly available information.

    Why regulatory nod to vaccines is under public scrutiny

    Covishield

    Serum Institute of India submitted immunogenicity data of only about 185 people from phase 2 trial

    No efficacy data from the vaccine’s phase 3 trial in India

    Dosing schedule with a 4-12 week gap permitted but the vaccine has been tested at a gap of only four weeks in India so far

    Covaxin

    Current enrolment for phase 3 trial is around 22,000 but no phase 3 efficacy data available or submitted

    The regulator said that the rollout of the vaccine will be in ‘clinical trial mode’ but there is no explanation yet on what it means

    A claim is being propagated that the Whole-Virion inactivated vaccine will be effective against mutations but this is not being supported by any evidence

  • Schools reopen in Arunachal Pradesh for students of Classes 8, 9, 11

    By PTI
    ITANAGAR: Schools reopened for students of Classes 8, 9 and 11 in Arunachal Pradesh on Monday after over nine months, adhering to standard operating procedures and COVID-19 protocols, officials said.

    Residential schools and hostels, however, will remain closed for now, they said.

    Classes for students of 10th and 12th standard had already resumed from November 16.

    “The parents have extended cooperation by sending their wards to schools and the students, too, are a happy lot to come to school after such a long period,” Education Minister Taba Tedir said.

    Colleges in the state would reopen from Tuesday, he said.

    “We are in constant touch with the health department and if it is found feasible, we may look at resuming other classes, too,” the minister said.

    He also urged students and parents to wear face masks, maintain social distancing and wash hands frequently, and follow other advisories issued by the state government in the wake of the pandemic.

  • Eight UK returnees have new COVID-19 strain in Maharashtra: Health Minister Rajesh Tope

    By PTI
    MUMBAI: As many as eight returnees to Maharashtra from the UK have been found to be infected with the new COVID-19 variant detected in the European country, health minister Rajesh Tope said on Monday.

    Of these, five are from Mumbai, he said, adding contacts of all the COVID-19 patients with the UK strain are being traced.

    Out of 4,000 returnees from the UK, 43 people have tested positive for COVID-19, out of which eight have the new variant,” Tope said in a televised message, citing results of their swab samples.

    “The protocol to treat them is different and they have been isolated from the other COVID-19 patients,” he said.

    The new coronavirus variant found in the UK is said to 70 per cent more infectious than the first one.

    Out of the eight, five are from Mumbai and one each from Pune, Thane and Mira Bhayandar.

    The contact tracing of these patients is going on, Tope said.

    “Asymptomatic patients have been advised 14-day strict quarantine while those with compromised immunity such as (people with) diabetes and high blood pressure, among others, 21 days of quarantine, said the state health minister. The government has decided to treat the patients with symptoms till they get cured. We need to strictly follow COVID-19-appropriate behaviour such as frequently washing hands, use of masks and avoiding crowded places, Tope said.

  • Consistent fall in India’s active caseload due to decline in daily infections: Health ministry

    By PTI
    NEW DELHI: The decline in India’s daily COVID-19 cases has ensured a consistent fall in the active caseload, which constitutes 2.36 per cent of the total infections, while higher testing has led to the positivity rate further going down to 5.89 per cent, the Union health ministry said on Monday.

    India’s cumulative tests have gone past 17.5 crore (17,56,35,761), with 7,35,978 samples being tested the previous day, it said.

    “One crore tests were conducted in the last 11 days. Higher testing has led to a further decline in the cumulative positivity rate at 5.89 per cent,” the ministry said.

    India’s testing infrastructure has received a boost with 2,299 labs across the country, it said.

    ​ALSO READ | World’s biggest COVID-19 vaccination programme set to begin in India: PM Modi

    A net decline of 3,267 cases was recorded in the total active cases the previous day, the ministry said.

    As on date, India’s active caseload stands at 2,43,953.

    India’s COVID-19 recoveries are inching closer to one crore.

    The total number of recovered cases has surged to 99,46,867, which translates to a recovery rate of 96.19 per cent.

    A total of 19,557 people recovered the previous day, the ministry said.

    Of the new recoveries, 76.76 per cent were observed to be concentrated in 10 states and union territories (UTs) — Kerala, Maharashtra, West Bengal, Chhattisgarh, Uttar Pradesh, Tamil Nadu, Madhya Pradesh, Gujarat, Rajasthan and Karnataka.

    ALSO WATCH:

    Kerala reported the highest number of single-day recoveries at 4,668, followed by 2,064 in Maharashtra and 1,432 in West Bengal.

    Of the new cases, 83.90 per cent were concentrated in 10 states and UTs –Kerala, Maharashtra, West Bengal, Tamil Nadu, Karnataka, Uttar Pradesh, Madhya Pradesh, Gujarat, Chhattisgarh and Rajasthan.

    Kerala reported the highest number of new cases at 4,600.

    Maharashtra reported 3,282 new cases while West Bengal reported 896.

    Another 10 states and UTs — Maharashtra, West Bengal, Kerala, Uttar Pradesh, Madhya Pradesh, Chhattisgarh, Delhi, Punjab, and Tamil Nadu — accounted for 77.57 per cent of the 214 deaths reported the previous day.

    Maharashtra reported 35 deaths, followed by 26 in West Bengal and 25 in Kerala.

  • India reports 16,504 new COVID-19 cases; less than 20,000 for third consecutive day

    By PTI
    NEW DELHI: Daily new COVID-19 cases in the country remained below 20,000 for the third consecutive day taking the virus caseload to 1,03,40,469, while the recoveries surged to 99.46 lakh, according to the Union Health Ministry data updated on Monday.

    A total of 16,504 tested positive for coronavirus infection in a day.

    The death toll increased to 1,49,649 with 214 new fatalities, the data updated at 8.00 am showed. The number of people who have recuperated from the disease surged to 99,46,867 pushing the national recovery rate to 96.19 per cent, while the COVID-19 case fatality rate stands at 1.45 per cent.

    ALSO READ | When can I get COVID vaccine, how to register for it: Here is all you need to know

    The COVID-19 active caseload remained below 3 lakh for the 14th consecutive day.

    There are 2,43,953 active cases of coronavirus infection in the country which comprise 2.36 per cent of the total caseload,the data stated.

    India’s COVID-19 tally had crossed the 20-lakh mark on August 7, 30 lakh on August 23, 40 lakh on September 5 and 50 lakh on September 16.

    It went past 60 lakh on September 28, 70 lakh on October 11, crossed 80 lakh on October 29, 90 lakh on November 20 and surpassed the one-crore mark on December 19.

    According to the ICMR, 17,56,35,761 samples have been tested up to January 3 with 7,35,978 samples being tested on Sunday.

    ALSO WATCH:

  • When can I get COVID vaccine, how to register for it: Here is all you need to know

    By Online Desk
    The Centre will inoculate 30 crore people belonging to priority groups in the first phase of its vaccination drive.

    In the initial phase, healthcare and frontline workers will be covered under the vaccination drive. They will be followed by those above 50 and people with comorbidities. The government is in the process of determining the specific clinical criteria under which the people with underlying conditions will be identified for the purpose. In all, 31 hubs had been established to supply vaccines to 29,000 vaccination points in last-mile delivery.

    Union Health Minister Harsh Vardhan has appealed to people not to be misguided by “rumours” regarding the safety and efficacy of the coronavirus vaccine, and said the most prioritised beneficiaries would be vaccinated for free. 

    The vaccines would be provided in the first phase of the inoculation drive to the most prioritised beneficiaries, including one crore healthcare and two crore frontline workers.

    Here are the Frequently Asked Questions about COVID-19 vaccination

    Who will get the vaccine first and how soon can I have it?

    1. Healthcare workers: The vaccine will first be given to around 1 crore healthcare workers in government and private hospitals such as doctors, nurses, medical supervisors, medical officers, paramedical staff, support staff, and medical students.

    2. Frontline workers: The next in line are about 2 crore frontline workers in central and state police departments, armed forces, home guard, disaster management, civil defence organisation, jail staff, municipal workers, revenue officials on Covid duty, employees of state governments and Union ministries of defence, home, housing, and urban affairs

    3. Population above 50: The third in line are the people above 50. The latest electoral rolls will be used to identify the population under this category for the vaccination drive.

    4. People in highly-affected areas: Governments will prioritise groups of people in highly-affected areas as decided by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC)

    5. The rest: The remaining population will be vaccinated after the people on the priority list are covered. The vaccination here will depend on the disease epidemiology and vaccine availability. To avoid overcrowding at the vaccination session site, the vaccine will be given to the beneficiaries in a staggered manner.

    In the first two stages, the government will vaccinate priority groups including frontline workers and emergency workers. People with co-morbidities will get the jab in the third stage. For this, a self-registration process will be required through the Co-WIN app.

    ALSO READ | COVID-19 vaccines 110 per cent safe, impotency rumours complete nonsense: DCGI

    How to register for the vaccine?

    The Centre has launched a new mobile app called ‘CoWIN App’ which will let you register for Covid vaccination.

    Soon, it will be available to download for free on the Google Play Store and Apple app store. 

    There are five modules in the app: Administrator module, registration module, vaccination module, beneficiary acknowledgment module, and report module. 

    The administrator module is for the administrators who will be conducting these vaccination sessions.

    The registration module is for people to get registered for vaccination. It will upload bulk data on co-morbidity provided by local authorities or by surveyors.

    The vaccination module will verify the beneficiary details and update the vaccination status.

    The beneficiary acknowledgment module will send SMS to beneficiaries. It will also generate QR-based certificates after you are vaccinated.

    The report module will prepare reports on the number of vaccine sessions, people vaccinated and dropped out cases.

    ALSO READ: Medical team from Kerala joins CSIR-IGIB to study vaccine’s effect in controlling mutated virus

    Here’s a step-by-step guide: 

    Self-register on the CoWIN website

    Upload Aadhaar for authentication or use any photo identity issued by the government 

    The authentication can happen via biometrics, OTP, or other demographic information

    Once registered, you will be allocated a date and time for vaccination

    Your district authorities will be the approving authority 

    They will regulate the session management in CoWIN system and allocate you session and site for vaccination

    The CoWIN system will generate QR-based certificates after you are vaccinated

    Where will I be vaccinated?

    Vaccination will be conducted at three types of sessions sites:

    Fixed session site: Government and private health facilities – where either a medical officer or a doctor is available is defined as a fixed session site.

    Outreach session site: Sites such as schools and community halls

    Special mobile session: For those living in remote, hard-to-reach areas

    What will be the process for vaccination at the session site?

    The vaccination site will have three rooms:

    Waiting room: Wait here for your turn before you get the vaccine

    Vaccination room: It’s the place you will be administered the vaccine 

    Observation room: You will be observed for 30 minutes post-vaccination

  • Bharat Biotech’s COVID-19 vaccine more likely to work against newer strains like UK variant: Harsh Vardhan

    By PTI
    NEW DELHI: With some Congress leaders raising concerns over the grant of approval to Bharat Biotech’s COVID-19 vaccine, Health Minister Harsh Vardhan asserted on Sunday that Covaxin is more likely to work against newer variants of the virus, including the UK variant, and asked politicians not to “discredit well laid out science-backed protocols” followed for approving the jab.

    Some Congress leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, on Sunday raised serious concerns over the grant of approval to Covaxin for restricted use, saying it is “premature” and can prove dangerous.

    Responding to them, Vardhan said it is “disgraceful for anyone to politicise such a critical issue.”

    ALSO READ: A great milestone in India’s scientific capability – Bharat Biotech on Covaxin’s approval

    Tagging Tharoor, Ramesh and Samajwadi Party leader Akhilesh Yavad, the health minister said in a tweet, “…don’t try to discredit well laid out science-backed protocols followed for approving #COVID19vaccines. Wake up & realise you are only discrediting yourselves!” Vardhan said, “COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein.”

    SP president Yadav said the COVID-19 vaccination programme is a “sensitive process” and the government should not treat it as a “cosmetic” event as it is a matter of lives.

    Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

    ALSO READ: COVID-19 vaccines 110 per cent safe, impotency rumours complete nonsense: DCGI

    ICMR Director General Balram Bhargava also said Covaxin is based on an inactivated whole virus, having potential to target mutated coronavirus strains including the UK variant, which was a major ground for giving it a conditional nod.

    He, however, said no clear data regarding the efficacy of the vaccine is available so far.

    The data generated so far demonstrates a strong immune response  (both antibody as well as T cell) and in-vitro viral neutralisation.

    The ongoing clinical trial is the largest trial on 25,800 subjects, in which already 23,000 volunteers have been enrolled including subjects with comorbid conditions, and the vaccine has demonstrated safety till date, Bhargava said.

    Further allaying apprehensions surrounding the Bharat Biotech vaccine, Vardhan said there were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of Covaxin clinical trials.

    Seroconversion is the transition from the point of viral infection to when antibodies of the virus become present in the blood.

    “Our experience with inactivated vaccines not having serious adverse events was also observed in Phase II done among 380 study participants in BBV152 trial in 21280 Person days follow up. No serious adverse events seen. Only 7 per cent persons receiving 6 microgram dose had mild symptoms,” Vardhan said in another tweet.

    “The data from COVAXIN Phase I & II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises  CD4 T lymphocytes that imparts durable immune response,” Vardhan tweeted.

    ALSO READ: Vaccines approved! SII, Bharat Biotech get DCGI nod for restricted use in emergency situation

    He said vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90 per cent.

    “However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein. So, it’s likely to have similar protective efficacy reported for others,” he said.

    India’s drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

    The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).