News Analysis India

Tag: Covishield

  • COVID-19 vaccine race: Where it stands currently

    By PTI
    NEW DELHI: Almost a year into the COVID-19 pandemic, about 200 vaccine candidates are in the works and 10 have been either approved by several countries or are under limited emergency use.

    As India prepares to launch its vaccine drive on January 16, here is a look at the options:  

    COVAXIN

    Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology, the indigenous vaccine was granted emergency use authorisation in clinical trial mode’ by the Indian government this week.

    It is an “inactivated” vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction.

    This process leaves the viral proteins, including the spike protein of the coronavirus which it uses to enter the human cells, intact.

    Given as two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus.

    According to Bharat Biotech, the therapeutic can be stored at room temperature for at least a week.

    A study on the Phase 1/2 trial published in the preprint server medRxiv in December showed the therapeutic doesn’t cause any serious side effects.

    However, there has been no further data released in the public domain which could demonstrate that the vaccine is safe and effective.

    “ICMR-Bharat Biotech vaccine is a killed whole-virus vaccine and there are absolutely no data available so far on its protective efficacy. I am critical of its getting approval by the authorities,” immunologist Vineeta Bal, affiliated with the National Institute of Immunology in New Delhi, told PTI.

    COVISHIELD

    Co-developed by the University of Oxford and British-Swedish company AstraZeneca and known as Covishield in India, the vaccine was the first on which a scientific study was published based on Phase 3 clinical trials.

    It has so far been given emergency use authorization in the UK, Argentina, Mexico and India.

    Scientists have engineered a version of adenoviruses that infect chimpanzees to carry the gene responsible for the spike protein of the novel coronavirus.

    It requires two doses, provided four weeks apart, to produce the desired effects.

    Manufactured by the Serum Institute of India, Covishield will be sold at Rs 1,000 per dose in the private market but cost the Indian government only Rs 200, said SII CEO Adar Poonawalla,   “Oxford-AstraZeneca-Serum Institute vaccine has shown protective efficacy in global trials to the tune of 60-70 per cent.

    While clear data from bridging trials in India are not available, the vaccine is certainly proven safe,” Bal said.

    According to virologist Upasana Ray from the CSIR-Indian Institute of Chemical Biology, Kolkata, the AstraZeneca-Oxford vaccine is less restricted in terms of cold storage as it can be stored, transported and handled at normal refrigerator temperatures (2-8 degrees Celsius) for at least six months.

     MODERNA

    The mRNA vaccine by US-based company Moderna has so far been approved for use in Israel, the EU, Canada and the US.

    A study of the efficacy of Moderna vaccine revealed it has 94.1 per cent efficacy in preventing the disease.

    In this type of vaccine, the messenger RNA — or mRNA — acts as a blueprint for the production of the coronavirus spike protein and is encapsulated by lipid molecules and delivered into human cells.

    The cells of the vaccine recipient then use this mRNA genetic code to produce the viral protein to train the immune system for a future encounter with the infectious coronavirus.

    Administered as two doses, four weeks apart, the Moderna vaccine can reportedly be stored in the refrigerator at 2-8 degrees Celsius for up to 30 days.

    At -20 degrees Celsius it can be stored for up to six months.

    This is still a challenge for many developing countries in the tropical regions that experience very high temperatures in the summer months.

    In November last year, Moderna Chief Executive Stephane Bancel told a German weekly that the company would charge governments between USD 25 and 37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered.

    PFIZER-BIONTECH

    The US-backed Pfizer-Biontech’s COVID-19 preventive, like the Moderna vaccine, is based on the segments of the genetic material of the novel coronavirus.

    Preliminary data from the clinical trials showed that two doses of the vaccine, given three weeks apart, provided an efficacy of over 90 per cent.

    Following the results, the UK, Canada, the EU and Saudi Arabia have approved the Pfizer vaccine for use.

    Several countries, including the US, Singapore, Argentina and Mexico, have given emergency use authorisation.

    ne limitation for the Pfizer vaccine has been its requirement for ultracold storage — up to -70  degrees Celsius.

    Each dose is reportedly priced at USD 37.

    SPUTNIK V 

    Sputnik V from Russia’s Gamaleya Research Institute has been approved for emergency use by several countries but awaits more results from Phase 3 trials.

    An adenovirus vectored vaccine, Sputnik V is produced using a combination of two adenoviruses called Ad5 and Ad26.

     Preliminary evidence from Phase 3 trials indicates it is 90 per cent effective when given as two doses, three weeks apart.

    In November, the Russian Direct Investment Fund said the cost of the vaccine would be less than USD 10 per dose starting from February 2021.

    It said the dry form of the vaccine can be stored at 2-8 degrees Celsius, and does not need freeze storage.

    CONVIDECIA

    The adenovirus vectored vaccine developed by the Chinese company CanSino Biologics is also under Phase 3 trials and has already been approved for limited use by the Chinese military.

    Since August, the vaccine has been part of Phase 3 trials in several countries, including Russia, Mexico and Pakistan.

    CORONAVAC

    Another Chinese company, Sinopharm, has also made progress with its inactivated vaccine dubbed CoronaVac.

    It has been given emergency approval for limited use in the country.

    The vaccine is reportedly provided as two doses, administered two weeks apart.

    Scientists are yet to publish a study on the trial conducted so far.

    VECTOR INSTITUTE

    Russia’s Vector Institute has developed a protein vaccine.

    It is currently under Phase 3 clinical trials.

    It uses modified versions of the coronavirus spike protein to induce immunity.

    The vaccine reportedly can be stored at 2-8 degrees celsius for up to two years.

    Data on the efficacy of the therapeutic is yet to be released.

    NOVAVAX

    After showing promising results in Phase 1-2 trials, and in animal experiments, the vaccine developed by US company Novavax is currently under Phase 3 clinical trials.

    It uses modified versions of the coronavirus spike protein to induce immunity, and can reportedly be stored at 2-8 degrees Celsius.

    After some setbacks in manufacturing the doses required for the Phase 3 study in the US, the trial was finally launched on December 28.

    JOHNSON&JOHNSON

    The adenovirus vectored vaccine by the American company has shown protection against the coronavirus in experiments in monkeys and is currently part of Phase 3 clinical trials.

    Unlike other vaccines, this vaccine is reportedly provided as a single dose, but trials are currently underway to test its efficacy as two doses.

    The company had noted that the therapeutic can be stored for up to three months when refrigerated at 2-8 degrees Celsius, and up to two years when frozen at -20 degrees Celsius.

  • 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)

  • 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.

  • Makers of Covishield and Covaxin bury hatchet after spat, pledge smooth rollout of vaccines

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

    “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,” they said. According to sources, this came after a nudge from top functionaries in the Union government.

    Covaxin by Bharat Biotech and Covishield by Serum Institute of India, which has made the vaccine after technology transfer by Oxford University-AstraZeneca, have been granted restricted emergency use permission by the Central Drugs Standards Control Organisation.

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

    Poonawalla had said apart from his vaccine, only vaccines by Pfizer and Moderna had shown efficacy while others including Covaxin were only “safe, like water.”

    Retorting to this, Ella in a press conference on Monday said his company had carried out a 200% honest trial in the national interest, without any financial aid, and did not deserve the backlash.

    The joint statement, aimed at presenting a united effort towards the government’s upcoming immunisation drive against COVID-19 said, “Vaccines are a global public health good and they have the power to save lives and accelerate the return to economic normalcy at the earliest.”

    “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,” said the statement undersigned by Ella and Poonawalla.

    It added, “Both our companies are fully engaged in this activity and consider it our duty to the nation and the world at large to ensure a smooth rollout of vaccines. Each of our companies continue their COVID-19 vaccines development activities as planned.”

    The statement added that they are fully aware of the importance of vaccines for people and countries alike and hereby communicate their joint pledge to provide global access for their COVID-19 vaccines.

  • 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

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

    Express News Service
    NEW DELHI: V G Somani, Drug Controller General of India (DCGI) on Sunday announced that the recommendations of a government-appointed panel to grant restricted emergency use authorization to Covid-19 vaccines by Serum Institute of India and Bharat Biotech in the country are being accepted.

    The Pune-based SII is manufacturing and clinical trial partner for the coronavirus vaccine by Oxford University-AstraZeneca under the brand name ‘Covishield’ while Bharat Biotech, in collaboration with the ICMR has developed the country’s first indigenous vaccine- ‘Covaxin’.

    After adequate examination, the Central Drugs Standard controller CDSCO has decided to accept the recommendations of the expert committee and accordingly vaccines of SII and Bharat Biotech for restricted use in emergency situations, said Somani in a press briefing.

    Prime Minister Narendra Modi took to Twitter to call the development a ‘decisive turning point to strengthen a spirited fight’, against coronavirus.

    In a briefing to the press, in which no questions were taken, Somani meanwhile said that the subject expert committee of the CDSCO consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine,  among others.

    In the case of Covishield, Somani said SII submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies.

    ALSO READ: COVID-19 vaccines to be free in first phase, says Govenment

    “The overall vaccine efficacy was found to be 70.42 %..The firm also submitted the interim safety and immunogenicity data generated from local trial and the data was found comparable with the data from the overseas clinical studies,”

    #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

    Somani said that despite the approval of the vaccine, the clinical trial ongoing within the country will continue.

    In case of Covaxin, the DCGI said that the firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.

    All these data has been shared by the firm with CDSCO, he said adding that phase 1 and 2 clinical trials were conducted in nearly 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.

    “The Phase 3 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 available till date,” said Somani.

    ALSO READ: Vaccine or not, mask is here to stay

    Reading from a statement, the official also said that for the vaccine, an expert committee has recommended for grant of permission for restricted use in emergency situations in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.

    He, however, did not share specific details of what it meant to roll-out the vaccine in “clinical trial mode”. 

    As per the details shared, the clinical trial ongoing within the country by the firm will continue.

    Somani also said that both Covishield and Covaxin have to be administered in two doses and all the three vaccines—third being one by Zydus Cadila which has been issued permission to begin phase 3 trial- have to be stored at 2-8-degree Celsius.

  • CDSCO approves emergency use of Corona Vaccine Kovishield

    Emergency use of Corona vaccine Kovishield has been approved in the country. Corona vaccination campaign will be started in India from 6 January. The Kovishield vaccine to be made at the Serum Institute of India has been approved by the Expert Committee of the Central Drug Standards Control Organization.

    However, the Kovishield vaccine is yet to get the final approval from the Drug Controller of India. The Serum Institute of India is preparing the Oxford-AstraZeneca vaccine in India.

    The 10-member Subject Expert Committee of India’s Central Drug Standards Control Organization on Friday approved the Emergency Use Authority of the Oxfodz-AstraZeneca Coronavirus Vaccine Covishield. The expert panel convened a meeting on behalf of the Serum Institute of India to decide on the Emergency Use Authority sought by Kovshield and Bharat Biotech for covacine.

    Once the way has been cleared for the vaccine from the committee, the application for final approval will be sent to DCGI VG Somani. The Health Ministry said that the decision on Bharat Biotech’s covarine is still awaited.

    Significantly, on December 6, the Serum Institute of India applied to the DCGI for obtaining formal approval for the emergency use of the Kovid-19 vaccine Kovishield of Oxford in India. Earlier, DCGI VG Somani indicated that Kovid-19 vaccine could come in India in the new year.

  • SII CEO Poonawalla makes big announcement after PM Modi visit

    Hours after Prime Minister Narendra Modi visited Pune-based pharma company Serum Institute of India (SII) on Saturday (November 28), the company’s CEO Adar Poonawalla said that his company will seek permission for emergency use authorization of ‘Covishield’ in the next two weeks.

    Few days, SII CEO Poonawalla had said that that the company is focused on supplying vaccines to India first. “It is very important we take care of our country first, then go on to Covax after that and then other bilateral deals with countries. So I’ve kept it in that priority,” Poonawalla had told reporters.

    “I am delighted to hear that, Covishield, a low-cost, logistically manageable & soon to be widely available, #COVID19 vaccine, will offer protection up to 90% in one type of dosage regime and 62% in the other dosage regime. Further details on this, will be provided this evening,” Adar Poonawalla had tweeted on November 23.

    “As of now, we do not have anything in writing with the government of India on how many doses they will purchase but the indication is that it would be 300-400 million doses by July 2021,” he added.

    Earlier on Saturday, PM Modi visited the SII facility in Pune and met Poonawalla and his team. “Had a good interaction with the team at Serum Institute of India. They shared details about their progress so far on how they plan to further ramp up vaccine manufacturing. Also took a look at their manufacturing facility,” PM Modi tweeted.

  • Covid 19 Vaccine News: Serum Institute told how long people will get ‘Covishield

    New Delhi: In India, an important statement about 73 days in Corona vaccine coming Serum Institute of India unfolded. The Serum Institute said that the government has just given us permission to produce and store the vaccine for future use only. It was clearly stated by the company that Covishield will be launched in the market only if there is complete success in the trials and regulatory approvals are obtained.

    Some media reports had said that the Covishield vaccine of Serum Institute of India will come to market within 73 days. At the same time, now the company has clearly stated that it is just speculation. The vaccine will be brought to market only when all its trials are successful and Kovishield will receive regulatory approval.

    The company tweeted that we would like to clarify that the claim of availability of Covishield in 73 days is misleading. Phase 3 trials are currently underway. We will officially confirm its availability soon.

    Let us know that the phase 3 trial of Oxford-AstraZeneca vaccine is going on. For this vaccine named Covishield, a deal has been signed between Serum Institute of India (SII) and AstraZeneca. There will be phase 2 and 3 trials of vaccine at 10 centers across the country. SII has also agreed to prepare one billion doses of this vaccine.

    On the other hand, today Health Minister Dr. Harsh Vardhan said that if all goes well, the country’s first corona vaccine will come by the end of this year. He said that currently the third phase trial of Corona vaccine has started in the country. The corona vaccine is expected to be launched in India in the next two to three months.