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Tag: Zydus Cadila

  • Zydus Cadila’s COVID vaccine to be administered only to adults as of now: Sources

    By PTI

    NEW DELHI: Zydus Cadila’s COVID-19 vaccine ZyCov-D, which has been cleared by India’s drug regulator for those aged 12 years and above, will only be administered to adults as of now under the government’s national anti-coronavirus vaccination programme, sources said on Sunday.

    The health ministry has given a go ahead to initiate the preparatory work for the inclusion of the indigenously-developed, needle-free jab in the national Covid inoculation drive and it can be introduced in the programme anytime soon.

    The ministry has already placed a purchase order with the Ahmedabad-based firm for one crore doses of the vaccine.

    “ZyCov-D, which has been cleared by India’s drug regulator for those aged 12 years and above, will be given only to adults as of now under the national Covid vaccination drive,” an official source said.

    Union Health Minister Mansukh Mandaviya on Thursday said the government does not want to make haste about administering Covid vaccines to children and any decision in this regard will be taken based on expert opinion.

    He said children are not being inoculated against COVID-19 on a large scale anywhere in the world, though it has been initiated in some countries in a limited manner.

    “About vaccinating the children, we will take a decision based on expert opinion. We have decided to think and evaluate before going ahead with vaccinating children as they are the future of our country and we need to tread with caution in this matter,” Mandaviya had said.

    Meanwhile, a comprehensive programme for paediatric immunisation, including developing a priority list of comorbidities, is being worked out by the National Technical Advisory Group on Immunisation (NTAGI).

    ZyCov-D is the first Covid vaccine cleared by India’s drug regulator for inoculation of those aged 12 years and above.

    As for the emergency use approval for Bharat Biotech’s Covaxin in the age group of two to 18 years by the Drugs Controller General of India (DCGI), it is under expert opinion and evaluation, official sources said.

    For administering ZyCov-D to adults, frontline workers and vaccinators will be provided a brief training for using the needle-free applicator in actual field settings.

    At present, every citizen aged above 18 years is eligible for Covid vaccination.

    Drug firm Zydus Cadila on November 8 said it had received an order to supply one crore doses of its Covid vaccine, ZyCoV-D, to the Indian government at Rs 265 per dose.

    “Zydus Cadila has received an order to supply one crore doses of ZyCoV-D, the world’s first Plasmid DNA Vaccine, to the Government of India at Rs 265 per dose and the needle-free applicator is being offered at Rs 93 per dose, excluding GST,” the pharma firm said in a regulatory filing.

    The vaccine will be administered using a needle-free applicator as opposed to the traditional syringes.

    The applicator is called “PharmaJet”.

    PharmaJet is a needle-free applicator to ensure painless intradermal vaccine delivery, which also leads to a significant reduction in any kind of major side effects.

    ZyCoV-D is the first DNA plasmid vaccine in the world for human use, developed indigenously by the company against COVID-19, Zydus Cadila said.

    The three doses of ZyCoV-D are to be administered 28 days apart.

    The vaccine was given emergency use authorisation (EUA) by the Indian drug regulator on August 20.

  • Need to tread with caution: Mandaviya on giving Covid vaccine to children

    By PTI

    NEW DELHI: Union Health Minister Mansukh Mandaviya on Thursday said the government does not want to make haste about administering COVID-19 vaccine to children and any decision in this regard will be taken based on expert opinion.

    On when vaccination for children could start as Zydus Cadila’s Covid vaccine has been granted emergency use authorisation for those 12-year-old and above, he said children were not being inoculated against COVID-19 on a large scale anywhere in the world though it has been initiated in some countries in a limited manner.

    “We do not want to rush this thing. Since this is a matter related to children, the expert group is carrying out further studies,” he said at the ‘Times Now Summit 2021’.

    All the vaccines which have currently received emergency use authorisation will be granted full authorisation only after a detailed study and based on the data of four to five years, he said.

    “It is through data and experience we have learnt that even after vaccination Covid can happen.

    Then again, data emerged stating that after vaccination one does not get severe Covid.

    The first dose gives 96 per cent protection and both doses give 98.5 per cent protection.

    “About vaccinating the children, we will make a decision based on expert opinion. We have decided to think and evaluate before going ahead with vaccinating children as they are the future of our country and we need to tread with caution in this matter,” the minister said.

    On the probability of administering a booster dose, he said adequate stocks are available and the aim is to complete the vaccination of the target population with two doses.

    After that, a decision on booster dose would be taken based on expert recommendation, Mandaviya said.

    “The government cannot take a direct decision in such a matter. When the Indian Council of Medical Research and expert team will say that a booster dose should be given, we will consider it then,” he said, adding Prime Minister Narendra Modi has always depended on expert opinion, be it vaccine research, manufacturing or approval.

    Despite a large population and diverse challenges, nearly 80 per cent of India’s adult population have taken at least the first dose.

    The country’s vaccination performance has been remarkable, Mandaviya said.

    About Covaxin’s approval by WHO, the minister said that he had discussed the matter with WHO chief Tedros Adhanom Ghebreyesus on more than a couple of occasions to understand the requirements a vaccine needed to fulfil to get the clearance.

    “It is a matter of great pride that a vaccine developed and manufactured in India has been given EUA status.”

    Asked if the delay in getting the EUA was because Covaxin is an Indian vaccine and if there was there any discrimination against India, the Mandaviya replied, “I will not get into this matter.”

    He informed that 97 countries have recognised Covishield and Covaxin.

    In the coming days, vaccines manufactured in India will be made available around the globe at affordable rates, Mandaviya said and stressed India will play a major role in global covid vaccination efforts.

    “We will get 31 crore doses in November with more due in December. Another five to six companies are set to come to India to manufacture vaccines here. We will help meet the world’s requirement for Covid vaccines by providing USD 18 to 20 vaccines at USD 3 to 4. This is our commitment,” he said.

    The minister said that 16 crore vaccine doses are lying with the states and Union Territories.

    Referring to the ‘Har Ghar Dastak’ vaccination at doorstep campaign, he said, “By December 31 we want to complete our target of vaccinating people aged 18 and above. It now depends on people’s support.”

    Asked about the possibility of a third wave, Mandaviya said, “Covid is not over. Cases are rising globally. In Russia, China, Hong Kong cases are rising again despite more than 80 per cent vaccination. Vaccination and Covid-appropriate behaviour have to go hand in hand.”

    On preparations for a probable third wave, he said Ayushman Bharat Health Infrastructure Mission has been launched and Rs 65,000 crore will be spent in the next five years to ramp up the health infrastructure across the country.

    The aim is to form such a level of preparedness that India is ready to fight a pandemic-like exigency if anything like it comes up in the next 50 years, the Union health minister said.

    “The second wave pointed out the shortages in health infrastructure. But, we don’t believe in a blame game. PM Modi has linked health with development and the government under his leadership always made efforts to expand and strengthen health facilities,” he said.

    Discussing the Health Infrastructure Mission, Mandaviya said modern laboratories will be set up at the district level which will conduct 115 types of medical tests for the poor citizens free of cost.

    Critical care units will be set up at the district level equipped with a 100-bed facility that has oxygen and ventilators.

    Besides, a research centre at the regional level will be set up so that epidemics are recognised on time before they assume pandemic proportions, he said.

    Meanwhile, children below five years are exempted from both pre- and post-arrival testing for COVID-19 in India, according to the revised guidelines for international arrivals released on Thursday.

    However, if found symptomatic for coronavirus infections on arrival or during home quarantine period, they shall undergo testing and be treated according to laid down protocol, the guidelines said.

    Highlighting that the global trajectory of COVID-19 pandemic continues to decline with certain regional variations, the document stated the need to monitor the continuously changing nature of virus and evolution of SARS-CoV-2 variants of concern must still remain in focus.

    The existing guidelines (issued on February 17 with subsequent addendums) for international arrivals in India have been formulated taking a risk-based approach.

    In view increasing vaccination coverage across the globe and the changing nature of the pandemic, the existing guidelines for international arrivals in India have been reviewed, the health ministry said.

    “Children under 5 years of age are exempted from both pre- and post-arrival testing. However, if found symptomatic for COVID-19 on arrival or during home quarantine period, they shall undergo testing and treated as per laid down protocol,” it said.

    This standard operating procedure shall be valid from November 12 (00.00 Hrs IST) till further orders, the ministry stated.

    Also, 15 days must have elapsed since completion of COVID-19 vaccination schedule.

    According to the existing guidelines, if travellers are fully vaccinated and coming from a country with which India has reciprocal arrangements for mutual acceptance of WHO approved COVID-19 vaccines, they shall be allowed to leave the airport and need not undergo home quarantine.

    They shall self monitor their health for 14 days’ post arrival.

    If partially or not vaccinated, the travellers need to undertake measures which includes submission of sample for post-arrival COVID-19 test at the point of arrival after which they will be allowed to leave the airport, home quarantine for seven days, re-test on the eighth day of arrival in India and if negative, further selfmonitor of their health for next seven days.

    15 days must have elapsed since completion of COVID-19 vaccination schedule,” the guidelines said.

    Travellers under home quarantine or self-health monitoring, if develop signs and symptoms suggestive of COVID-19 or test positive for COVID-19 on re-testing, they will immediately self isolate and report to their nearest health facility or call national helpline number (1075)/ state helpline number.

    On arrival deboarding should be done ensuring physical distancing and thermal screening would be carried out in respect of all the passengers by the health officials present at the airport.

    The self-declaration form filled online shall be shown to the airport health staff.

    The passengers found to be symptomatic during screening shall be immediately isolated and taken to medical facility according to health protocol.

    If tested positive, their contacts shall be identified and managed according to laid down protocol.

    Contacts of the suspect case are the co-passengers seated in the same row, three rows in front and three rows behind along with identified cabin crew.

    Also, all the community contacts of those travellers who have tested positive (during home quarantine period) would be subjected to quarantine for 14 days and tested as per ICMR protocol , the guidelines stated.

  • Centre places purchase order for one crore doses of Zydus’ needle-free Covid vaccine

    By PTI

    NEW DELHI: Zydus Cadila’s three-dose Covid vaccine ZyCoV-D is set to be included in the national anti-coronavirus inoculation programme this month with the Centre placing a purchase order with the Ahmedabad-based firm for one crore doses, official sources said on Sunday.

    The Union Health Ministry is learnt to have given the go ahead to initiate the preparatory work for the introduction of the indigenously developed world’s first DNA-based Covid jab, which in all probability will be given to adults initially under the country’s vaccination drive, sources in the know of developments said.

    ZyCoV-D is the first vaccine cleared by India’s drug regulator for inoculation of those aged 12 years and above.

    “The Centre has already placed a purchase order with Zydus Cadila for supply of one crore doses of ZyCoV-D, each costing around Rs 358 excluding taxes, at the earliest. This price includes the cost of a disposable painless jet applicator which has to be used for administering each dose,” an official source said.

    “The vaccine in all probability will be given to adults initially because of limited production capacity,” the source said.

    Zydus Cadila is in a position to provide one crore doses of ZyCoV-D per month, company officials are learnt to have conveyed to the ministry.

    For administering to adults, frontline workers and vaccinators will be provided a brief training for using the needle-free pharma jet application in actual field settings.

    The three doses of ZyCoV-D are to be administered 28 days apart, with each dose comprising a shot in both arms.

    ZyCoV-D received emergency use authorisation from the drug regulator on August 20.

    Meanwhile, a comprehensive programme for paediatric immunisation including developing a priority list of comorbidities is being worked out by the NTAGI (National Technical Advisory Group on Immunisation) for the launch of ZyCoV-D and Covaxin.

    As for the emergency use approval for Bharat Biotech’s Covaxin in the 2 to 18 years age group by the Drugs Controller General of India, it is under expert opinion and evaluation, official sources said.

    The Subject Expert Committee (SEC) on COVID-19 of the Central Drug Authority on October 12 had recommended granting emergency use authorisation to Covaxin for children and adolescents in the 2 to 18 years age group with certain conditions.

    At present, every citizen who is 18 years or above is eligible for the vaccination drive.

  • Zydus Cadila agrees to reduce its Covid vaccine price, final decision soon: Sources

    To administer the needle-free ZyCov-D vaccine, a disposable painless jet applicator costing Rs 93 is required for each dose, which would take the price to Rs 358 per dose.

  • ‘Lack of vaccine applicators delaying ZyCoV-D launch’, say government officials

    By Express News Service

    NEW DELHI: The availability of a special applicator required to administer Covid vaccine by Zydus Cadila is delaying its launch in the country, government officials have said.  ZyCoV-D is the first Covid vaccine in India to be approved for 12-17 year age group apart from adults. The government had intended to launch it on October 2 for giving an impetus to the ongoing national Covid vaccination drive.

    “However, first there was delay owing to the price negotiation between the government and the company and then there was the issue of availability of applicators as the vaccine needs to be administered intradermally,” said a source in the Union health ministry.

    The source added that the applicator which costs about Rs 30,000 and can be used for about 20,000 doses should be available in India by this week, paving the way for the vaccine’s launch. The applicators are being produced by Pharmajet and are not made in India.

    The Ahmedabad-based company had projected the vaccine as a painless vaccine that has to be administered in three doses. The firm, though has not published data from the phase 3 trials of the DNA based vaccine yet, has claimed that it was about 67 % effective in reducing Covid, including that caused by Delta variant.

  • Debate over prices halted launch of Zydus’ Covid-19 vaccine on Gandhi Jayanti?

    Express News Service

    NEW DELHI: Even as disagreement over the price of Covid-19 vaccine by Zydus Cadila between the company and the government has delayed its launch in the national vaccination drive, the Centre is insisting on Rs 300 per shot for the vaccine which is to be administered in three doses.

    Earlier, the plan was to roll out the ZyCoV D vaccine, the only vaccine approved also for the 12-17 year age group so far, on October 2 on the occasion of Gandhi Jayanti.

    Sources in the Union government said that in a meeting between government officials and company representatives on Sunday, the firm had quoted a price of Rs 1,900 for the three doses of the vaccine, which is based on plasmid DNA and its three doses are to be given over a 56-day period.

    “We are, however, negotiating to procure the vaccine for Rs 900 for the three doses as the government will also need to invest in a needle-free jet injector that has to be used for administering the vaccine,” said a senior official.

    The applicator by PharmaJet costs about Rs 30,000 and can be used for administering around 20,000 doses.

    Sources added that a few more rounds of negotiations are likely this week before a government procurement price, as well as the price of the vaccine in private hospitals can be fixed.

    The government is hoping to procure nearly 1 crore doses of the vaccine this month while till the year-end, the company has committed to supply about 5 crore doses of the vaccine.

    In a press briefing last week, Union health secretary Rajesh Bhushan had said that the vaccine will be priced differently than the jabs being used currently.

    “Since this is a three-dose vaccine and comes with a needleless delivery system, it would have a differential pricing than the existing vaccines which are being used in Covid vaccination,” he had said.

  • Zydus Cadila proposes Rs 1900 for three-dose COVID vaccine; Govt negotiating to bring it down

    By PTI

    NEW DELHI: With talks underway between the central government and Zydus Cadila over the pricing of the COVID-19 vaccine ZyCov-D, the pharma company is learnt to have proposed a price of Rs 1,900 for its three-dose jab that can be given to those above 12 years of age.

    However, the government is negotiating for a reduction in price and a final decision on it is likely to be taken this week, sources in the know of the developments told PTI.

    The government had on Thursday said that the indigenously-developed, world’s first DNA-based needle-free COVID-19 vaccine by Zydus Cadila will be introduced in the nationwide anti-coronavirus vaccination drive shortly.

    “The company has proposed a price of Rs 1,900 inclusive of taxes for its three-dose jab. 

    “Negotiations are on. The company has been asked to reconsider all the aspects regarding the cost of the vaccine. A final decision on the price of the vaccine is likely to be taken this week,” a source said.

    Another source said the ZyCoV-D has to be differently priced than Covaxin and Covishield as, apart from being a three-dose vaccine, there is a needle-free jet injector used for administering the vaccine that costs Rs 30,000.

    That jet injector can be used for administering around 20,000 doses.

    The vaccine is to be given on days zero, 28 and 56.

    According to sources, around three rounds of meetings have taken place so far between the Centre and the company, the last one on Thursday.

    Meanwhile, the ministry is also waiting for the recommendations from the National Technical Advisory Group on Immunisation (NTAGI ) for introducing ZyCoV-D in the inoculation drive and prioritising beneficiaries focusing on those aged 12-18 years with comorbidities.

    The NTAGI will provide the protocol and framework for the introduction of this vaccine in the COVID-19 immunisation drive, an official source said.

    As far as the price of the vaccine at which it will be procured is concerned, Union Health Secretary Rajesh Bhushan, at a press conference on Thursday, said the government is in conversation with the manufacturers.

    “Since this is a three-dose vaccine and comes with a needleless delivery system, it would have a differential pricing than the existing vaccines which are being used in the COVID vaccination programme,” he said.

    The vaccine ZyCoV-D received Emergency Use Authorisation from the drug regulator on August 20 making it the first vaccine to be administered in the age-group of 12 to 18 besides adults.

    Vaccines Covishield, Covaxin and Sputnik V are being given to only those above 18 years of age and unlike ZyCoV-D, these are two-dose vaccines.

  • Zydus Cadila jab to be rolled out tomorrow

    Express News Service

    NEW DELHI:  Ahmedabad-based Zydus Cadila’s three-dose Covid-19 vaccine is likely to be included in the national vaccination drive from Saturday, according to Union Health Secretary Rajesh Bhushan. Officials said negotiations between the Centre and the vaccine maker about the price and supply are in the final stages. 

    Sources said ZyCoV-D, approved by the drug regulator in August, is likely to be the most expensive Covid-19 vaccine to be procured by the government as it has to be administered in three doses and needs a special applicator instead of a syringe.

    “ZyCoV-D will be administered on Day 0, Day 28 and Day 56 using an applicator costing Rs 25,000, which can be used for 10,000 people,” said an official, adding that the government will have to buy the equipment along with the vaccine. 

    ZyCoV D has also been approved for inoculating 12-17 year-olds. Being a needle-free vaccine, it ensures painless vaccine delivery.  Nearly 1 crore doses of the vaccine are expected to be available in October. 

  • ZyCoV-D to be introduced in Covid vaccination drive shortly: Government

    By PTI

    NEW DELHI: The government on Thursday said Zydus Cadila’s indigenously-developed needle-free COVID-19 vaccine ZyCoV-D will be introduced in the nationwide anti-coronavirus vaccination drive very shortly and would have a differential pricing than the jabs being used currently.

    As far as the price at which it will be procured is concerned, Union Health Secretary Rajesh Bhushan told a press conference that the government is in talks with the manufacturer.

    “As far as the price of the vaccine at which it will be procured is concerned, we are in conversations with the manufacturer. Since it is a three-dose vaccine and comes with a needleless delivery system, it would have a differential pricing than the existing vaccines that are being used in the Covid vaccination programme,” he said.

    “It will be introduced in the COVID-19 vaccination drive very shortly,” Bhushan added.

    As regards the WHO clearance for Covaxin, Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava said, “We know that scientific data, public health considerations and international health requirements are all considered on which the clearance is given by the WHO. All these have been provided and are being looked at. It will be decided by the World Health Organization accordingly.”

    ZyCoV-D has received the Emergency Use Authorisation from the Drugs Controller General of India (DCGI) and will be administered to people aged 12 years and above.

    The Covishield, Covaxin and Sputnik V vaccines are being given to only those above 18 years of age and unlike ZyCoV-D, which is a three-dose vaccine, these are administered in two doses.

    The Department of Biotechnology (DBT) had earlier said ZyCoV-D is the world’s first DNA-based vaccine against the coronavirus and when injected into the human body, produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance.

  • Zydus Cadila vaccine likely to seek 2-dose approval, not 3

    Express News Service

    NEW DELHI:  India’s second indigenously developed Covid-19 vaccine — ZyCoV-D by Zydus Cadila — that was approved last month for the national vaccination programme is set to seek approval for a two-dose regimen, in a departure from a schedule permitted earlier.

    The permission granted by DCGI in August was for a three-dose schedule, which was tested for efficacy in the Phase 3 clinical trials. Sources said that ZyCoV-D, which showed an efficacy of about 66.6% for preventing Covid-19 infection, is planning to move a fresh application to the Central Drugs Standard Control Organisation for allowing the vaccine to be administered in two doses.

    Currently, the plasma DNA based vaccine has been permitted to be administered on Day 0, Day 28 and Day 56. “While the vaccine has been approved for a three-dose schedule, it will be logistically more convenient and user friendly if the vaccine can be administered in two doses,” said a source. As of now, tests are underway to check the efficacy of the vaccine in two doses and with concrete data in hand, the firm will apply to the CDSCO for a change in the dosing regimen.

    ZyCoV-D is the first vaccine in India also permitted for 12-17 year olds apart from adults. It has also been touted as a needle free vaccine that can be administered with a applicator which ensures painless intra-dermal vaccine delivery.

    The Ahmadabad-based firm has claimed that the platform used in the vaccine, because of its rapid plug and play technology, can be easily adapted to deal with mutations in the virus, such as those already occurring. The company is looking to launch the vaccine commercially by this month, though it is yet to announce its price for the private market. It is in negotiations with the government over the rate at which the Centre will purchase it for the national programme.

    Like other Covid-19 vaccines in India, 75% of ZyCov-D manufactured every month will be picked up by the Union health ministry for supply to the states. The rest will be available for private hospitals and will be available for beneficiaries at a pre-decided rate.

    Nearly 10-12 crore doses have been planned to be manufactured annually. But by year end, about 5 crore doses are likely to be supplied by the company which had stockpiled about 15-20 million doses before the vaccine was granted restricted use authorisation.