News Analysis India

Tag: Serum Institute of India

  • IAF, airlines to be roped in for COVID-19 vaccine transport across India

    By Express News Service
    NEW DELHI:  Commercial airlines as well as the Indian Air Force are being roped in to transport the vaccine vials as the government prepares to start giving the first jabs to immunize the people against Covid-19 next week, said sources.

    The transportation of vaccines to different parts of the country could begin Thursday evening or Friday morning.

    Officials in the Union health ministry, in consultation with the National Expert Group on Vaccine Administration on Covid-19, aviation ministry and cargo operators on Thursday prepared a detailed outline for vaccine transportation.

    The first vaccine vials, said officials in the health ministry, are set to be from Pune where the Serum Institute of India has manufactured the ‘Covidshield’ developed by Oxford University-AstraZeneca. 

    The Centre has planned 41 mini-hubs across the country for the distribution of vaccines, which are mostly in state capitals where they will be stored before finally being dispatched to districts.  

    Delhi and Karnal will be made mini-hubs for northern India while for the eastern part of the country, Kolkata and Guwahati will be the mini-hub for distribution. Guwahati will also be a nodal point for the Northeast.

    Chennai and Hyderabad will be the designated points for south India. Union health minister Harsh Vardhan, meanwhile, reviewed the preparedness for Covid dummy run on Friday in a virtual meeting with health ministers from the states.

    The Union health ministry has informed states and union territories that they are likely to receive the first supply of COVID-19 vaccine shortly and asked them to remain prepared to accept these consignments.

    In a communique, the ministry said vaccine will be supplied to the identified consignee points of 19 states and union territories — Andhra Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Gujarat, Haryana, Jharkhand, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Odisha, Punjab, Rajasthan, Tamil Nadu, Telangana, Uttar Pradesh and West Bengal — by the supplier.

    The vaccine for remaining 18 states and union territories — Andaman and Nicobar Islands, Arunachal Pradesh, Chandigarh, Daman and Nagar Haveli, Daman and Diu, Goa, Himachal Pradesh, Jammu and Kashmir, Ladakh, Lakshadweep, Manipur, Meghalaya, Mizoram, Nagaland, Puducherry, Sikkim, Tripura and Uttarakhand — will be received from their respective government medical store depots.

    “All the states and UTs are likely to receive the first supply of COVID-19 vaccine shortly.

    “In this regard, you are requested to ensure the advance preparation and readiness for the acceptance of forthcoming supply of the vaccine,” Dr Pradeep Halder, advisor, Reproductive and Child Health (RCH) in the health ministry, said in the letter dated January 5.

    The further distribution of vaccine to the districts will be done as per the registered beneficiaries, for which a separate communication will be done shortly, the letter stated.

    The country’s drugs regulator on Sunday approved Oxford-AstraZeneca’s Covishield and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country.

    The Health Ministry on Tuesday said it is prepared for COVID-19 vaccine roll-out within ten days of the vaccines getting approved for restricted emergency use on January 3, but a final decision on the launch date would be taken by the government.

    Meanwhile, as a simulation of actual execution of COVID-19 vaccine roll-out, another round of dry run will be conducted in all districts of all states and union territories, except Uttar Pradesh and Haryana, on January 8 to ensure efficient planning and management for vaccine delivery in each district.

    (With PTI Inputs)

  • Now, Bharat Biotech, SII pledge for smooth rollout of COVID-19 vaccines

    By Express News Service
    NEW DELHI:  After their much-publicised spat, Krishna Ella and Adar Poonawalla, head Bharat Biotech and Serum Institute of India respectively, issued a joint statement on Tuesday pledging their commitments towards a smooth rollout of Covid-19 vaccines in the country and the world.

    In a joint statement, the two companies noted that the most important task in front of them was saving lives and livelihoods in India and globally. “We are fully aware of the importance of vaccines for the people and countries alike, we hereby communicate our joint pledge to provide global access for our vaccines,” it said.

    Sources said the statement came following a nudge from the top functionaries in the Union government. Covaxin by Bharat Biotech and Covishield by SII, which has made the vaccine after technology transfer by Oxford University-AstraZeneca, have been granted restricted emergency use by the Central Drugs Standards Control Organisation. 

    Poonawalla had said apart from his vaccine, vaccines by only Pfizer and Moderna had shown efficacy while other vaccines including Covaxin were only “safe, like water.” At a conference on Monday, Ella, without naming Poonawalla, said his company had carried out a 200% honest trial in the national interest, without any financial aid, and did not deserve the backlash.

    “Now that two Covid-19 vaccines have been issued EUA in India, the focus is on manufacturing, supply and distribution, such that populations that need it the most receive high quality, safe and efficacious vaccines,” the statement said.

    It added: “Both companies respect the great work being carried out by each other and put behind us the miscommunication and misunderstanding caused during the past week.” On Tuesday, Poonawalla tweeted that there would be a statement clearing up the miscommunication.

  • 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.

  • ‘Approved, safe, effective’: SII CEO Adar Poonawalla says Covishield is ready to roll out

    By PTI
    PUNE: Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’ is ready to roll out in the coming weeks.

    Poonawalla’s remarks came soon after after India’s drugs regulator approved Covishield for restricted emergency use.

    “Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off.”

    Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
    — Adar Poonawalla (@adarpoonawalla) January 3, 2021

    “COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks,” Poonawalla tweeted.

    “Thank you Hon. Sri @narendramodi Ji, Hon. Sri @drharshvardhan Ji, @MoHFW_INDIA @ICMRDELHI @DBTIndia #DCGI_India @UniofOxford @AstraZeneca @gavi @GaviSeth @gatesfoundation and @BillGates for your support,” he added.

    COVID-19 vaccines of Serum Institue of India and Bharat Biotech have been granted permission for restricted use in emergency situation, said Drugs Controller General of India (DCGI) on Sunday. 

    #BREAKING | A very happy new year indeed! India’s drug controller has approved #Covaxin and #Covishield for emergency use in the country.#Covid19vaccine #CovidVaccine pic.twitter.com/QQWMzWufxs
    — The New Indian Express (@NewIndianXpress) January 3, 2021

    The SEC of Standard Drug Organisation met on 1st and 2nd Jan and made recommendations in respect of proposal of restructed emergency approval of COVID-19 vaccine of SII, according to DCGI.

    SII Pune has submitted safety immunogenisity and efficacy data generated on 23,745 participants aged more than or equal to 18 years or older from overseas clinical studies, said VG Somani, DCGI.

  • Homegrown Covaxin gets expert committee’s nod, some fear international backlash

    Express News Service
    NEW DELHI: A government-appointed panel of the apex drug regulator on Saturday recommended emergency use authorization for Bharat Biotech’s Covaxin, India’s first homegrown vaccine against Covid-19, a day after it approved a Covid vaccine by AstraZeneca-Oxford University in the country.

    The committee said that the recommendation was for the vaccine’s restricted use in emergency situations in “public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains”.

    Bharat Biotech, in collaboration with the ICMR has developed Covaxin from inactivated SARS CoV 2, isolated at the National Institute of Virology, Pune. And though the vaccine has demonstrated good safety and immunogenicity in phase 1 and 2 clinical trials, it is still undergoing phase 3 trial in the country and therefore, its efficacy remains to be established.

    Meanwhile, the Centre also publicly made a statement that the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organization, following its meetings on Friday and Saturday made the recommendations for the consideration and final decision of the Drugs Controller General of India. 

    “Grant of permission for restricted emergency use of vaccine (is being given), subject to multiple regulatory conditionalities, to Serum Institute of India, Pune,” said a statement by the Union ministry of health and family welfare. 

    The back-to-back permissions granted to the vaccines could mean that they will be rolled out simultaneously in about a week. 

    The unscheduled meeting of the SEC on Saturday had been called to reconsider the application by Bharat Biotech reportedly under government pressure even as the panel had refused the permission a day earlier citing insufficient data.

    The arguments made in favour of  Covaxin included its use of a familiar platform, capacity to generate antibodies against multiple proteins, promise of 6 to 12 months protection and T-cell response implying immune memory.

    “The company also argued that antibodies against multiple proteins instead of spikes alone raises hope that it might have a better chance against the mutated variants,” a source in the committee said. A senior member of the national task force on Covid-19 expressed astonishment at the development.

    “There may be theoretical advantages such as potential benefits of using a whole viral particle as opposed to spike protein vaccines in fighting new variants like B117 and the opportunity to quickly scale up the vaccination campaign,” he said. 

    “However, under any circumstances, rules of the game must be honoured,” he also said, adding that the move may draw backlash internationally, especially from bodies like the World Health Organization.

    “There seems to be a political desire to release an Indian vaccine ahead of the visit by the British Prime Minister Boris Johnson and there is pressure from local groups,” confirmed a member of the National Expert Group on Vaccine Administration on Covid-19.

    The drug regulator’s expert panel meanwhile also approved phase 3 clinical trial of the Covid-19 vaccine by Ahmedabad based drug maker Zydus Cadilla.