News Analysis India

Tag: Pfizer

  • Pfizer says COVID-19 pill cut hospital, death risk by 90 per cent

    By PTI

    WASHINGTON: Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joins the race to bring the first easy-to-use medication against the coronavirus to the U.S. market. Currently all COVID-19 treatments used in the U.S. require an IV or injection.

    Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.

    Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results.

    Once Pfizer applies, the FDA could make a decision within weeks or months. Researchers worldwide have been racing to find a pill against COVID-19 that can be taken at home to ease symptoms, speed recovery and reduce the crushing burden on hospitals and doctors.

    Pfizer released preliminary results Friday of its study of 775 adults. Patients taking the company’s drug along with another antiviral had an 89% reduction in their combined rate of hospitalization or death after a month, compared to patients taking a dummy pill. Fewer than 1% of patients taking the drug needed to be hospitalized and no one died.

    In the comparison group, 7% were hospitalized and there were seven deaths. “We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90% efficacy and 100% protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer, in an interview.

    Study participants were unvaccinated, with mild-to-moderate COVID-19, and were considered high risk for hospitalization due to health problems like obesity, diabetes or heart disease. Treatment began within three to five days of initial symptoms, and lasted for five days.

    Pfizer reported few details on side effects but said rates of problems were similar between the groups at about 20%.

    An independent group of medical experts monitoring the trial recommended stopping it early, standard procedure when interim results show such a clear benefit.

    The data have not yet been published for outside review, the normal process for vetting new medical research.

    Top U.S. health officials continue to stress that vaccination will remain the best way to protect against infection.

    But with tens of millions of adults still unvaccinated, and many more globally, effective, easy-to-use treatments will be critical to curbing future waves of infections.

    The FDA has set a public meeting later this month to review Merck’s pill, known as molnupiravir. The company reported in September that its drug cut rates of hospitalization and death by 50%.

    Experts warn against comparing preliminary results because of differences in studies. Although Merck’s pill is further along in the U.S. regulatory process, Pfizer’s drug could benefit from a safety profile that is more familiar to regulators with fewer red flags.

    While pregnant women were excluded from the Merck trial due to a potential risk of birth defects, Pfizer’s drug did not have any similar restrictions.

    The Merck drug works by interfering with the coronavirus’ genetic code, a novel approach to disrupting the virus.

    Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.

    The drug, which has not yet been named, was first identified during the SARS outbreak originating in Asia during 2003.

    Last year, company researchers decided to revive the medication and study it for COVID-19, given the similarities between the two coronaviruses.

    The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus.

    But they have to be given by IV or injection at hospitals or clinics, and limited supplies were strained by the last surge of the delta variant. Shares of Pfizer spiked more than 9% before the opening bell Friday.

  • With domestic manufacturing picking up pace, India unlikely to buy Pfizer, Moderna vaccines for now: Sources

    By PTI

    NEW DELHI: India is unlikely to buy Pfizer and Moderna COVID-19 vaccines for now as the domestic manufacturing of anti-coronavirus jabs has picked up pace, sources said with the total doses administered in the country crossing 83 crore on Wednesday.

    Though there is no official word, the sources said the government is not ready to give in to the indemnity demands of the US drug manufacturers against liabilities in case of adverse effects.

    The Pune-based pharmaceutical company Serum Institute of India has enhanced the manufacturing capacity of Covishield to more than 20 crore doses per month and has informed the Centre that it will be able to supply around 22 crore doses in October.

    Also, Bharat Biotech is currently producing nearly 3 crores doses of Covaxin each month and its production is likely to be ramped up to 5 crores in the coming months.

    “In the initial days of the vaccination drive, there was requirement of jabs, but that has been met with the ramping up of domestic production. Also, these indigenously produced vaccines are much more affordable and do not have special cold chain requirements,” a source told PTI.

    Union Health Minister Mansukh Mandaviya on Monday announced that India will resume export of surplus COVID-19 vaccines in the fourth quarter of 2021 under the ‘Vaccine Maitri’ programme and to meet its commitment to the COVAX global pool, but vaccinating its own citizens remains the topmost priority of the government.

    Talking about the expected production and supply trends in the coming months, he said the government will receive over 30 crore doses of COVID-19 vaccines in October and over 100 crore doses in the coming quarter from October-December.

    The cumulative doses administered in the country so far under the nationwide COVID-19 vaccination drive has exceeded 83 crore.

    According to official sources, over 22 per cent of India’s adult population have received both doses of vaccine and 65 per cent have got at least one dose.

    Of all the vaccine doses administered, around 88.45 per cent are Covishield, nearly 11.44 per cent Covaxin and less than one per cent Sputnik V.

    India on September 17 administered a record number of over 2.50 crore vaccine doses on the occasion of Prime Minister Narendra Modi’s 71st birthday.

    The daily COVID-19 vaccination in the country was over 1 crore on September 6, August 31 and August 27.

    India took 85 days to touch the 10-crore vaccination mark, 45 more days to cross the 20-crore mark and 29 more days to reach the 30-crore mark, according to the ministry.

    The country took 24 days to reach 40 crore from 30 crore doses and then 20 more days to cross the 50-crore vaccination mark on August 6, it said.

    It took 19 more days to go past the 60-crore mark and took only 13 days to reach 70 crore from 60 crore on September 7.

    It then took just 11 days to reach 80 crore from 70 crore.

  • Pfizer, Moderna vaccines wouldn’t have got nod had they done phase three trials in second wave: Krishna Ella

    Hyderabad-based Bharat Biotech, the manufacturer of COVID-19 Covaxin, said the efficacy of its vaccine would have been 85 per cent against the original strain of the virus.

  • 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.”

  • Pfizer, AstraZeneca vaccine antibody levels may decline after 2-3 months: Lancet study

    By PTI
    LONDON: Total antibody levels start to wane six weeks after complete immunisation with Pfizer and AstraZeneca vaccines, and can reduce by more than 50 per cent over 10 weeks, according to study published in The Lancet journal.

    The researchers from University College London (UCL) in the UK noted that if the antibody levels carry on dropping at this rate, there are concerns that the protective effects of the vaccines may also begin to wear off, particularly against new variants.

    However, they said, how soon that might happen cannot be predicted yet.

    The UCL Virus Watch study also found that antibody levels are substantially higher following two doses of the Pfizer vaccine than after two shots of the AstraZeneca preventive, known as Covishield in India.

    Antibody levels were also much higher in vaccinated people than those with prior SARS-CoV-2 infection, they said.

    “The levels of antibody following both doses of either the AstraZeneca or Pfizer vaccine were initially very high, which is likely to be an important part of why they are so protective against severe COVID-19,” said Madhumita Shrotri from UCL Institute of Health Informatics.

    “However, we found these levels dropped substantially over the course of two to three months,” Shrotri said in a statement.

    The findings based on data from over 600 people aged 18 and above were consistent across all groups of people regardless of age, chronic illnesses or sex, according to the researchers.

    The authors highlight that although the clinical implications of waning antibody levels are not yet clear, some decline was expected and current research shows that vaccines remain effective against severe disease.

    For Pfizer, antibody levels reduced from a median of 7506 Units per millilitre (U/mL) at 21–41 days, to 3320 U/mL at 70 or more days.

    For AstraZeneca vaccine, antibody levels reduced from a median of 1201 U/mL at 0–20 days to 190 U/mL at 70 or more days, over five-fold reduction.

    “When we are thinking about who should be prioritised for booster doses our data suggests that those vaccinated earliest, particularly with the AstraZeneca vaccine, are likely to now have the lowest antibody levels,” said Professor Rob Aldridge from UCL Institute of Health Informatics.

    The findings support recommendations that adults who are clinically vulnerable, those aged 70 years or over, and all residents of care homes for older adults should be prioritised for booster doses, the researchers said.

    In addition, those who were vaccinated with the AstraZeneca vaccine are likely to have much lower antibody levels than those vaccinated with the Pfizer vaccine, they noted.

    “This may also need to be considered when deciding who should be prioritised when boosters are rolled out,” Aldridge said in the statement.

    The team acknowledged certain limitations in the data, including a small sample size for some groups.

    The researchers noted that that each individual only contributed one sample, so they cannot yet confirm how quickly antibody levels drop for each individual, or whether these would continue to drop or reach a stable level over the next few months.

    They also noted that different people will have different levels of immunity depending on the virus neutralising ability of their antibodies as well as their T-cell responses.

    “Even when measurable antibody levels are low, there is likely to be continuing immune memory that could offer long-term protection,” the authors of the study noted.

    They said further research will be important to establish if there is an antibody level threshold needed for protection against severe disease.

    PTI SAR SAR 07271209 NNNN

  • Centre dragging feet on granting necessary approvals to Pfizer, Moderna: SAD chief Sukhbir Singh Badal

    By PTI
    AMRITSAR: Shiromani Akali Dal (SAD) chief Sukhbir Singh Badal on Saturday accused the Centre of dragging its feet on granting US pharma giants Pfizer and Moderna necessary permissions to export their COVID-19 vaccines to India and said the process should be expedited.

    He also asked Punjab Chief Minister Amarinder Singh to directly place orders with companies that are supplying vaccines instead of waiting to get doses from the Centre.

    Badal was speaking at the inauguration of a free vaccination ‘seva’, an initiative by the Shiromani Gurdwara Parbandhak Committee (SGPC), at the Golden Temple here.

    The ‘seva’ will be extended to Takht Sri Damdama Sahib in Bathinda and Takht Sri Keshgarh Sahib in Anandpur Sahib in the coming days, he said.

    The SAD chief accused Prime Minister Narendra Modi and CM Singh of having failed to fulfil their duty to provide vaccines to people.

    Badal expressed surprise over the alleged delay by the Centre in granting permission to companies like Pfizer and Moderna to export their vaccines to India and said all necessary approvals should be fast-tracked.

    Pfizer, which is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).

    The government is examining Pfizer’s request for indemnity and will take a decision in the larger interest of people and on merit, NITI Aayog Member (Health) V K Paul had said on Thursday.

    Badal also urged the Centre to waive the goods and services tax (GST) on Covid medicines, oxygen concentrators, ventilators and vaccines.

    “I don’t understand why the Centre wants to earn money by taxing life-saving medicines and machines and making them more expensive for the people. Even the SGPC had to pay GST on purchase of vaccines. This must be waived immediately,” he said.

    Badal asked Singh to place orders directly with companies that are supplying vaccines instead of waiting for the meagre supply from the Centre.

    He said the Punjab government should follow the example of the Mumbai municipal corporation, which used Rs 600 crore to purchase vaccines, and demanded that jabs worth Rs 1,000 crore be purchased immediately.

    States across the country have reported a shortage of Covid vaccine doses and some have been forced to halt the vaccination drive for certain age groups.

    Many states have also issued global tenders to procure vaccines.

    Punjab’s nodal officer for vaccination Vikas Garg had said on May 23 that the state has approached all vaccine manufacturers for direct purchase of Covid jabs including Sputnik V, Pfizer, Moderna, and Johnson & Johnson.

    While Moderna and Pfizer have refused to supply vaccines directly to the Punjab government, saying they deal only with the Centre, other firms haven’t yet responded, according to Garg.

    Badal decried the Congress-led Punjab government for not giving any relief to the people in this time of crisis and allegedly befooling them by claiming that it had affected a 20 per cent reduction in power tariff when nothing of this sort had been done.

    If the Congress government is really serious about providing relief to the common man and industry, it should have waived electricity bills for a six-month period.

  • Pursuing Pfizer, J&J and Moderna since mid-2020 for earliest possible vaccine imports: Government

    Express News Service
    NEW DELHI: Amid continuing criticism of its vaccination policy, the Centre on Thursday tasked its top COVID-19 advisor VK Paul to bust “myths” with “facts”. Getting right on to the task, Paul charged that the vaccination drive had been going on smoothly until the states sought “opening up of the process and decentralisation”. 

    He listed out seven widely talked about “myths” on the vaccination drive.  Shifting the blame for a chaotic vaccination drive to the states, Paul said: “The Centre ran the entire vaccine program from January to April, and it was quite well-administrated compared to the situation in May (new policy came in force from May 1, allowing those above 18 years for vaccinations).”

    Responding to criticism from some state governments that the Centre should be procuring vaccines instead of the states, Paul said, “The GoI has merely enabled the states to try procuring vaccines on their own, on their explicit requests.”

    Hitting out at some states over failed global tenders to procure vaccinations, Paul said, “States, that had not even achieved good coverage of healthcare workers and frontline workers in three months wanted to open up the process of vaccination and wanted more decentralisation.”

    He added, “Health is a state subject & the liberalised vaccine policy was a result of the incessant requests being made by the states to give states more power. The fact that global tenders have not given any results only reaffirms what we have been telling the states from day one: that vaccines are in short supply in the world and it is not easy to procure them at short notice.”

    Responding to claims that the Centre has not approved vaccines available globally, Paul said it has proactively eased the entry of vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India in April.

    At times, Paul’s exercise of busting the myths included thinly-veiled attacks on opposition leaders. “The behaviour of some of our leaders, who in spite of full knowledge of the facts on vaccine supply, appear on TV daily and create panic among the people is very unfortunate,” he said without naming anyone.

  • Centre waives ‘bridging trials’ to allow foreign vaccines for emergency use

    Express News Service
    NEW DELHI: The Centre has now decided to exempt foreign Covid vaccine makers from bridging trials in India completely, after announcing last month that the first 100 beneficiaries of foreign vaccines will be assessed for seven days for safety outcomes before the vaccine is incorporated in the immunization drive.

    The development comes in the backdrop of negotiation between the government and Pfizer over the import of its Covid vaccine in India, which is likely to begin from July.  

    VK Paul, member (health) Niti Aayog and chairman of the national expert group on vaccine administration for Covid said in a press conference on Wednesday that Pfizer has indicated the availability of its Covid vaccine for India while other terms of the agreement are under discussion.

    The company, he said, had sought indemnification from cost of compensation about which a final decision is yet to be taken.

    “Pfizer has indicated a certain volume of vaccine availability, possibly starting from July..looking at what their expectations are from us, and what we are our expectations from them,” said Paul in a press briefing by the Union health ministry on Covid status in India.

    ALSO READ | No adverse effect if second dose of different COVID vaccine taken: Government

    “They have requested indemnity from all nations, it’s their condition. We are examining this request. There is no decision as of now,” he added.

    A document released by Niti Aayog, in order to Prepa issue a detailed clarification on the narratives that that the government is not doing enough to ensure a ramped and quick supply of covid vaccines, meanwhile, said that the Centre has “proactively” eased entry of vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s emergency use listing into India in April. 

    “These vaccines will not need to undergo prior bridging trials,” said the statement. “The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.”

    On April 13, in a statement on fast tracking emergency approvals for foreign produced vaccines, the government had on the other hand said that the permissions would be granted, “mandating the requirement of post-approval parallel bridging clinical trials in place of conduct of local clinical trials.”

    “Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country,” it had said.

    Officials in the health ministry said that in December, 2020 when Pfizer had first applied for the emergency approval, it had insisted on doing away with the bridging trial completely—a demand that had been turned down completely.

    “As of now, however this vaccine has been used in several countries and there is real world data on its safety and efficacy, therefore we are okay to immediately launch the vaccine in the country’s Covid vaccination drive upon import,” said a top official.

  • Our vaccine highly effective on COVID-19 variant prevalent in India, suitable for 12 years and above: Pfizer to government

    By PTI
    NEW DELHI: Seeking a fast-track approval for its COVID-19 vaccine, US major Pfizer has told Indian authorities that its jab has shown “high effectiveness” against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday.

    Pfizer, which is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).

    “The current situation in India, and across the world, is not ‘business as usual’ and we must not respond to it with processes as usual too,” a source quoted Pfizer as having communicated to the Indian government.

    ALSO READ: Moderna’s single-dose COVID-19 vaccine in India likely next year; Pfizer ready with 5 crore doses for 2021

    Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer’s Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company’s COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies.

    While India has administered over 20 crore doses so far since the launch of its vaccination drive in mid-January, it is still a long way to reach the vaccination for the entire population, more so in the backdrop of many states having flagged shortage of vaccines and the gap between supply and requirement widening amid the deadly second wave.

    India is currently using mainly two ‘made-in India’ jabs Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.

    ALSO READ: Moderna says its COVID-19 vaccine works in kids as young as 12

    In its latest communication to the government, Pfizer has also thanked the Government of India to have agreed to its request for procurement through a central government pathway and to discuss “the Indemnity and Liability protection”.

    “The timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement,” the company told the government while seeking fast-tracking the regulatory pathway to help it supply “Pfizer’s COVID-19 vaccine as expeditiously as possible to India”.

    Pfizer has said India should “rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study.”

    The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed.

    It has also stated that the Pfizer vaccine has undergone significant development over the last six months which includes improvement in storage conditions at 208 degrees for over one month (31 days) at the site of vaccination.

    ALSO READ: After Moderna, Pfizer too says no to Punjab on vaccine supply, state urges Centre to intervene

    “Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity,” Pfizer has said.

    Providing data, it said UK’s Public Health England (PHE) has reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021).

    It further said 26 per cent of study participants overall were of “Indian or British Indian” ethnicity, and also included Bangladeshi (1.4 per cent), Pakistani (5.9 per cent) and any other Asian background (5.7 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.

    Also, the data from Qatar’s nationwide immunization program demonstrated high vaccine effectiveness -89 per cent against B.1.1.7 variant (first detected in the UK) and 75 per cent against B.1.351 variant (first detected in South Africa).

    It said 24 per cent of study participants were of Indian nationality (more than 6,000), and others included Nepalese (6-12 per cent), Bangladeshi (4-11 per cent), Sri Lankan (3-4 per cent), Pakistani (4-6 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.

    Pfizer has urged the Government of India to rely upon WHO’s testing pathways of reliance on testing certificates from country of origin instead of mandating local testing and batch release stating will also help fast track vaccine introduction and prevent vaccine wastage.

    Pfizer has also shared the most recent data on BNT162b2 mRNA vaccine — the phase 3 clinical trial showing vaccine efficacy six months after the second dose from the pivotal registration trial, as also for variants in vitro neutralization, clinically efficacy data and real-world vaccine effectiveness against emerging variants of SARS-CoV-2.

    The data shared with Indian authorities also include “real-world evidence of BNT162b2 vaccine effectiveness and safety from national immunization programmes”.

    The shared datapoints include trials showing nearly 95 per cent effectiveness against COVID-19, 100 per cent efficacy against severe disease and also 100 per cent vaccine efficacy in 12-15-year-old adolescents.

  • Moderna’s single-dose COVID-19 vaccine in India likely next year; Pfizer ready with 5 crore doses for 2021

    By PTI
    NEW DELHI: Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla among other Indian firms, while another US giant Pfizer is ready to offer 5 crore shots in 2021 itself but it wants significant regulatory relaxations including indemnification, sources said on Tuesday.

    While Moderna has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021, there are limited prospects of Johnson & Johnson exporting its jabs from the US to other countries in the near future, the sources privy to discussions added.

    Two rounds of high-level meetings chaired by the Cabinet Secretary were held last week on the availability of vaccines in the global as well as domestic markets as it was felt that there is an urgent need to procure the jabs at a time the country is reeling under an unprecedented second wave of COVID-19 and a widening gap between supply and requirement.

    ALSO READ: Moderna says its COVID-19 vaccine works in kids as young as 12

    Currently, the country is using two ‘made-in India’ jabs — Covishield and Covaxin — to inoculate its billion-plus population and has administered 20 crore doses since launching the world’s largest vaccination drive in mid-January.

    A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.

    In the high-level meeting officials from the Ministry of External Affairs, NITI Aayog, Department of Biotechnology, Law Ministry and Health Ministry were present.

    It was discussed that Moderna doesn’t have surplus vaccines to share in 2021 and that it plans to launch its single-dose vaccine for the Indian market only in 2022, for which, they are in discussion with Cipla and other Indian companies, a source said.

    It is learnt that Cipla has already evinced interest in procuring 5 crore doses from Moderna for 2022 and has requested confirmation from the central government in respect of stability in regulatory requirements/policy regime.

    ALSO READ: After Moderna, Pfizer too says no to Punjab on vaccine supply, state urges Centre to intervene

    The Health Ministry has also been asked to take an early decision on Cipla’s request regarding support required by them for procurement of Moderna vaccines.

    In the case of Pfizer, the US pharma giant has indicated availability of 5 crore vaccine doses — 1 crore in July, 1 crore in August, 2 crore in September and 1 crore in October –for supply to India in 2021 and that it will deal only with Government of India and payment for vaccines will have to be made by GOI to Pfizer India.

    The central government will make its own arrangement for further channelization of procured vaccines in the domestic market.

    According to another source, for the supply of vaccines to India, Pfizer has asked for indemnification from the Government of India and a document in this regard has been received from Pfizer Inc.

    Further, Pfizer has also sought certain relaxations in the regulatory regime, including relaxation in the requirement of post-approval bridging trials and dispensing the requirement of testing their vaccines in CDL (Central Drugs Laboratory).

    ALSO READ: Now, Pfizer, Moderna refuse to sell COVID-19 vaccines to Delhi government directly

    Taking into consideration the track record of the company, similar arrangements done with other countries in the world and the current pandemic situation, an overall view may be taken to indemnify the company by the government, officials said but flagged that in case a view is taken to indemnify the company, similar demands may be made by other companies.

    As per the information furnished by Pfizer, around 116 countries in the world including the USA have signed the indemnification document.

    Further, considering that over 14.7 crore doses of Pfizer had been administered worldwide without any significant reports of adverse effects, a view needs to be taken to indemnify the company in order to supplement the availability of vaccines in India, officials discussed at one recent meeting.

    It was suggested that a decision on the issue of Pfizer Inc may be taken at the earliest and that NEGVAC (National Expert Group on Vaccine Administration for COVID-19) may hold a meeting immediately on these issues.

    At a press conference on Monday, in response to a question on states being unable to procure vaccines directly from Moderna and Pfizer, Health Ministry Joint Secretary Lav Agarwal had said, “Whether it is Pfizer or Moderna, at the Centre-level, we have been coordinating with them.”

    “Also, the order book of both Pfizer and Moderna is full so it depends on their surplus that how much they can provide in India…they will come back to the Centre and we will help in facilitation to states,” he said.