News Analysis India

Tag: Pfizer-BioNtech

  • Pfizer-BioNtech vaccine set to be first fully approved coronavirus jab 

    Express News Service

    NEW DELHI:  The Covid-19 vaccine developed by Pfizer-BioNtech is set to become the first jab against the disease globally to move from emergency-use authorisation to full-approval stage after it submitted more data to US drug regulator from the late-stage clinical trials and ongoing vaccinations. 

    This mRNA-based vaccine was the first against Covid-19 to receive restricted use authorisation in the UK followed by the US in December last year. In India, the pharma giant’s negotiations with the government to launch the vaccine are still stuck over the issue of indemnity. 

    Full approval to the vaccine will mean the vaccine-maker can advertise directly to people and ensure its availability even after the pandemic ends. But most importantly, it is likely to help persuade those who are hesitant about getting vaccinated until the US Food and Drug Administrator fully gives approval to the shot.

    Also, this approval could pave the way for new vaccine requirements by public and private organisations which may make it mandatory for employees or service receivers to be vaccinated. So far, almost in all countries, shots against the coronavirus are largely voluntary—a primary reason why a large population is still unvaccinated. 

    Once it obtains the full licensure, Pfizer-BioNTech is also planning to apply to the USFDA for the approval of a third dose as booster shot. The US government last week had announced that fully vaccinated adults should prepare to get booster shots eight months after they received their second doses, beginning September 20.

    This came after new evidence emerged suggesting that the protection offered by the mRNA vaccine may wane after a few months. Back home, sources in the Central Drug Standard Control Organisation said that as of now the vaccines being used in India’s inoculation drive are nowhere near the full approval.

    “For complete licensure, vaccine makers need to submit far more details, particularly on safety aspects and emerging issues such as side effects post vaccinations,” said a CDSCO official. “However, we do not really see that happening in near future as for vaccine makers the priority now is to focus on scaling up the supplies to meet the need of vaccinations.”

  • 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.

  • Now emergency use of Pfizer vaccine can be done in America too, expert panel gave green signal

    Now the US may also approve the Pfizer-BioNtech Corona vaccine vaccine. Earlier Britain had granted such permission. Let us tell you that an emergency approval of the Pfizer-BioNotech Corona vaccine has been recommended by a US government advisory panel. Regarding this vaccine, the panel says that the potential benefit of the vaccine reduces its risks. The recommendation was followed by an eight-hour public hearing on Thursday, after which the Food and Drug Administration (FDA) vaccine and the associated Biological Products Advisory Committee (VRBPAC) voted to recommend the vaccine developed by Pfizer and its German partner Bioentech. VRBPAC member and children’s hospital Philadelphia vaccine specialist Paul Offit said that the impact of the Pfizer-BioNotech vaccine is clearly seen, it has a clear advantage and on the other hand we have theoretical risks on all sides. He said that the risks from this vaccine vaccine are reducing.

    At the same time, Ofer Levy, a pediatrician and head of the vaccine program at Boston Children’s Hospital, said it was a major milestone. Significantly, the UK and Bahrain have already approved the emergency use of this Pfizer-BioNotech vaccine. In a detailed analysis, the US Food and Drug Administration (FDA) has concluded that the first for use in the US Considered the Kovid-19 vaccine (Pfizer and BioNotech’s vaccine), this vaccine has proved to be successful to set standards in clinical studies.