News Analysis India

Tag: Coronavirus Outbreak

  • Nod to COVID vaccines: Doctors, scientists’ group suspects ‘profit, political gains’ came before science

    By PTI
    NEW DELHI: Days after two COVID-19 vaccines were granted restricted emergency use approval by India’s drug regulator, a national association of doctors and scientists on Tuesday said they suspect “profit and political gains took precedence over science”.

    In a statement, the Progressive Medicos and Scientists Forum said India was quick to criticise China and Russia for granting emergency approvals to vaccines without efficacy data, but it “failed to exercise diligence when its turn arrived”.

    “There are many reasons to suspect that profit and political gains have taken precedence over science,” the Progressive Medicos and Scientists Forum said.

    ALSO READ: Centre has not banned export of any COVID-19 vaccine, says Union Health Secretary

    The Drugs Controller General of India (DCGI) had 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.

    Industry experts and some opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin.

    The critics have cautioned that “sidestepping” processes and giving “premature” clearance could risk lives and fuel vaccine hesitancy in India.

    However, Bharat Biotech has rejected criticism over the grant of emergency use authorisation by India’s drug regulator to its COVID-19 vaccine, asserting it has a track record of producing safe and efficacious vaccines and has been transparent with all data.

    Krishna Ella, chairman of Bharat Biotech, said the company has done “200 per cent honest clinical trials” and yet it was receiving “backlash”.

    Covaxin addresses an unmet medical need and has generated excellent safety data with a robust immune response to multiple viral proteins that persist, Ella has said.

  • Schools, colleges to reopen in Rajasthan from January 18

    By PTI
    JAIPUR: Schools, colleges and other educational institutions will reopen in Rajasthan from January 18, after remaining closed for nearly nine months due to the COVID-19 lockdown, according to an official statement issued on Tuesday.

    The decision to reopen schools for the students of classes 9th to 12th, those in the final year in colleges, coaching institutes and government training institutes was taken by Chief Minister Ashok Gehlot during a review meeting.

    Medical College, Dental College, Nursing College and Paramedical College have been directed to reopen from January 11, taking into consideration COVID-19 vaccination.

    The chief minister said social distancing and other health protocols, including using face masks, should be taken care of in all institutions.

    Gehlot was reviewing the COVID-19 situation in the state through video conference.

    He said the cases of new strain of COVID-19 in the country and the state are of concern.

    “Any kind of negligence towards it can create a big crisis. In view of this, special attention should be kept on travellers coming to the state from other countries, including those affected by this virus,” the chief minister said.

    He said that due to the new virus strain, a terrible situation has risen in England and lockdown had to be imposed again.

    “Taking lessons from the UK, precaution should be taken in Rajasthan,” Gehlot said.

    The chief minister said the condition of coronavirus in Rajasthan is “very much under control with the best management and cooperation of the people”.

    The COVID-19 recovery rate has risen to an all-time high of 96.31 per cent, he said.

    Gehlot directed the officials to ensure that preparations for vaccination in the state is completed in a mission mode.

    “The entire database of health workers should be uploaded as soon as possible for vaccination,” the chief minister said.

    He said only authentic and substantive information about the vaccine should be circulated in the media.

    “Unverified information can cause unnecessary misconceptions among people,” he said.

  • Maharashtra company claims ‘Covishield’ trademark, files suit against SII

    By PTI
    PUNE: A civil court here on Tuesday issued a notice to the Serum Institute of India (SII) on a suit filed by a pharmaceutical products manufacturer and seller seeking to restrain the former from using trademark ‘Covishield’ or any other similar names for its upcoming COVID-19 vaccine.

    The Nanded-based firm, Cutis-Biotech, in its suit filed on Monday through advocate Aditya Soni, claimed it has been using the trademark ‘Covishield’ for its products like antiseptic, sanitisers, disinfectant liquid, surface de- containment spray and fruit and vegetable washing liquid since 2020.

    As per the suit, the firm filed an application for registration of ‘Covishield’ trademark on April 29, 2020, which is pending and the firm is using the trademark since May 30, 2020, for its products.

    The suit has sought an injunction against the SII from using the name ‘Covishield’ for its vaccine for the coronavirus.

    The court issued a notice to the Pune-based vaccine maker SII, seeking its response to the suit, and posted the suit for hearing on January 19.

    Cutis-Biotech added that the SII has also filed trademark applications for other names such as “COVIDOROTECT, COVID-VAC, COVI-VAC, COVI-VAXX” and thus could use any of these names for their vaccine.

    Soni said on December 7 last year, the plaintiff came across news that the SII has applied before the Drugs Controller General of India for immediate approval of the COVID-19 vaccine under the brand of “Covishield” in India.

    The suit said it was not seeking any restraint on the SII from launching the vaccine but the name should not be ‘Covishield’.

    The suit stated that the SII vaccine is yet to be launched in the market.

    “Therefore, if the injunction is issued against the defendant restraining it from using the trademark of the plaintiff (Covishield), no inconvenience is going to be caused to the vaccine maker.

    “However if the SII launches its product under the brand ‘Covishield’, injury and damage would be caused to Cutis-Biotech,” the suit said.

    Message sent to the SII seeking reaction to the suit did not elicit any response.

  • During pandemic, vaccine’s restricted use considered based on safety, immunogenicity data: ICMR chief Balram Bhargava

    By PTI
    NEW DELHI: In a pandemic situation, restricted emergency use of vaccines is considered based on safety and immunogenicity data while phase three clinical trial is underway, Indian Council of Medical Research (ICMR) chief Balram Bhargava said on Tuesday.

    Explaining the process followed in granting nod to Oxford COVID-19 vaccine and indigenously developed Covaxin, he said, “The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee (SEC) on COVID-19 of CDSCO for granting accelerated approval to these vaccines, and that is in our legal provision.”

    The Drugs Controller General of India (DCGI) had 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.

    Industry experts and some opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin.

    ALSO READ: Nod to COVID vaccines – Doctors, scientists’ group suspects ‘profit, political gains’ came before science

    The critics have cautioned that “sidestepping” processes and giving “premature” clearance could risk lives and fuel vaccine hesitancy in India.

    “In a pandemic situation, restricted use is considered based on safety and immunogenicity data while phase three clinical trail is still ongoing. The immunogenicity data generated through phase two clinical trial serves as a surrogate for efficacy. The Clinical Trial Rule, 2019, provides for considering phase two results to guide approval.

    “Now the SEC guides the DCGI in the process of decision making for restricted use under emergency situation. Now we have two vaccines,” Bhargava said.

    ALSO READ: Centre has not banned export of any COVID-19 vaccine, says Union Health Secretary

    Providing details of the UK studies of Covishield, the ICMR chief said animal studies showed that vaccine prevented SARS-CoV-2 pneumonia in monkeys and have elicited good immunogenicity in mice.

    The phase one and two clinical trials in 1,077 participants showed an acceptable safety profile, and homologous boosting increased antibody responses.

    Phase two and three in prime-boost regimen in 560 participants showed it was better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose.

    The result was published in the Lancet, the ICMR chief said.

    Phase 3 trial in 11,636 participants from UK and Brazil, with two standard doses, showed vaccine efficacy was 62·1 per cent, in case of a low dose followed by a standard dose, the efficacy was 90 per cent.

    Overall, Covishield efficacy was 70·4 per cent.

    This has been published online last month, he said.

    As for Covishield’s phase two and three clinical trial in India, there were 1,600 participants aged than 18 years.

    Their immunogenicity data is being generated, more than half is available.

    Covishield is safe and immunogenic and the data showed that it is “non-inferior to the UK product,” Bhargava said.

    “It was an important point that led to the approval,” he added.

    As for Covaxin, Indian studies on animals such as rats, mice, rabbits, hamsters and monkeys showing excellent safety, immunogenicity.

    It showed robust viral clearance in both the upper and lower respiratory tract in large animals.

    The phase one and two clinical trial on 375 and 380 participants respectively revealed very low adverse events, Bhargava said, adding, “It showed neutralising antibody responses equivalent to human convalescent serum, strong antibody responses to all structural proteins…three months after vaccination.”

    The phase three clinical trial will include 25,800 participants of which 24,000 have been enrolled so far.

    There are no safety concerns.

    They (participants) have been given their first dose and more than 5,000 give the second jab.

    “Permission for restricted use in clinical trial mode has been allowed which means consent of participants has to be taken and there has to be a regular follow up of participants,” Bhargava said.

    Explaining further, he said the manufacturer of Covaxin has been requested by the drug controller to provide the protocol for the clinical trial mode.

    Clinical mode means everyone will give consent for the vaccine, there will be no placebo and there will be a closer follow up.

    “As for the publications of Covaxin (trail), the animal studies have been published in Nature Communications and High science which is a cell journal. The phase one trial was being published in Lancet Infectious Diseases…and the phase two paper is under review there. They also have the protocol of phase three which is also under review by the British Medical Journal.”

    “There is another important publication in the Indian Journal of medical research which has compared the large animal data in all vaccine products and has shown the efficacy of this as well,” Bhargava said.

    Referring to The New Drugs and Clinical Trial Rules issued on March 19, 2019, he said it clearly states that if remarkable efficacy is observed with a defined dose in the Phase 2 clinical trial of investigational new drug for the unmet medical needs of serious and life threatening diseases in the country, it may be considered for grant of marketing approval by the Central Licensing Authority based on Phase 2 clinical trial data.

  • Centre has not banned export of any COVID-19 vaccine: Union Health Secretary

    By PTI
    NEW DELHI: The Union government has not banned the export of any COVID-19 vaccine that has been granted restricted emergency use approval by the drug regulator, the Health Ministry said on Tuesday, while urging the media to guard against the spread of such misinformation.

    The Drugs Controller General of India (DCGI) had 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.

    Responding to a question during a press briefing on Tuesday, Union Health Secretary Rajesh Bushan said, “The Union government has not banned the export of any one of the COVID-19 vaccines and this should be absolutely clear.”

    “When I say Union government, it means there are three ministries — Ministry of Health, Ministry of Commerce, the Department for Promotion of Industry and Internal Trade with the Ministry of Commerce and Directorate General of Foreign Trade — which can initiate, in a hypothetical scenario, such an action.”

    “But none of them have taken any such action. Therefore, our request to our media friends would be that we should be on guard when such misinformation is sought to be spread,” Bhushan said.

    The Union Health Secretary also highlighted two important points from a joint statement issued by the Serum Institute of India and Bharat Biotech.

    “The statement mentions two important elements. It says that vaccines are a global public health good. They also say that we communicate our joint pledge to provide global access for our COVID-19 vaccines. That means neither the Union government nor the vaccine manufacturers are talking of any ban on the export of vaccines,” he said.

    Serum Institute of India (SII) and Bharat Biotech on Tuesday said they will work together to develop, manufacture and supply the COVID-19 vaccines in India and globally.

    In a joint statement on behalf of the two companies, SII CEO Adar Poonawalla and Bharat Biotech Chairman and Managing Director Krishna Ella announced their combined intent to develop, manufacture and supply the COVID-19 vaccines for India and the world.

    They noted that the most important task in front of them was saving lives and livelihoods in India and globally.

  • 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.

  • 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).