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Vaccines in India: Pharmaceutical giants Pfizer and Johnson & Johnson yet to apply for emergency use authorization

Covid vaccines Pfizer

Two American pharmaceutical giants Pfizer and Johnson & Johnson are yet to apply for emergency use authorization for their Covid19 vaccines. This development comes days after centre stated that it is holding talks with Moderna and Pfizer over various issues including indemnity waiver. In June, Moderna announced that it has got permission and approval from India for importing vaccines into the country for restricted use in an emergency situation. Around the same time, CEO of Pfizer Albert Bourla had stated that the company is in the final stages to get approval for its vaccine in India. The centre had also acknowledged that it is in the final steps to close the deal with the pharma-giant Pfizer.

Also See: New mutants of Coronavirus

Dr VK Paul, member (health) of NITI Aayog had said, “We are in touch with them (Moderna and Pfizer). We are holding discussions. It is a process of negotiation and dialogues. We are trying to get a solution on contractual and commitments issues. This process is ongoing.”

On the approved vaccines, Dr. VK Paul stated, “There are four vaccines now Covaxin, Covishield, SputnikV and Moderna. We will soon close the deal on Pfizer as well.”

Also Read: An uncertain wait for vaccines by India despite a liberalized regulatory framework

US Food and Drug Administration (US FDA) & other western regulators have approved the Pfizer-BioNTech shot for emergency use. In USA, the vaccine has been approved for use in teens. The vaccine developed by Pfizer has an efficacy rate of 90% in preventing infection.

In June’s last week, Janssen’s maker J&J stated that it was in talks with the Indian government to explore ways to speed up the delivery of its single-shot Covid-19 vaccine in the country.

With a highly talked about and efficacious mRNA vaccine, Pfizer-BionTech, a leading global vaccine & medicine maker is all set to enter the Indian market. The company is said to have signed strategic deals with the Indian government. The deal of Pfizer with India is to supply close to 5 crore vaccine doses to India between July and October. The vaccine-maker is also in talks to sign an ‘indemnity clause’ which will free the vaccine maker of the liability of adverse reactions and potential side effects.

Pfizer’s mRNA vaccine shot has already been approved for use in leading countries like UK, USA, Canada, Brazil, Israel, Australia, Japan and Singapore. Its vaccine is considered to be highly effective and novel, with its unique messenger mRNA technology that instructs cells to produce a spike protein similar to SARS-COV-2’s and launch defensive action. Pfizer’s vaccine is delivered as a two-dose regime, spaced 21-28 days apart.

Also Read: Would vaccination drive in Canada be a mixed story for Ocugen?

Pfizer’s vaccine has been approved for use in kids between 12-18 years of age in select countries. This may also pave the way for kids’ vaccination in India. The different logistical hurdles of the vaccine, including the pricing and storage may require ramped up infrastructure as well.

Moderna too is an mRNA vaccine. Just like Pfizer, it has been approved for use in select countries. It carries strong odds of protection. As per reports, after Indian laws over regulatory authorisation were relaxed, the American vaccine maker is also expected to seek fast-track approvals in India. Different reports about the vaccine-industry pointed out that Indian drug-maker Cipla may form a strategic partnership with Moderna Therapeutics to bring over its innovative Covid19 vaccine by 2022. In last week of June, Cipla has received regulatory approval to distribute its partner-Moderna Inc’s (MRNA.O) Covid-19 vaccine in India.

In preventing symptomatic Covid19 & reducing the severity of the infection, Moderna’s mRNA model provides 94% efficacy as per various trial-research figures. There is also some evidence to suggest that Moderna’s vaccine would be able to prevent asymptomatic transmission as well. This has enabled it to win FDA nods. Just like for Pfizer, Moderna’s 2-3 week wait-period works well for Moderna’s COVID vaccine offering as well.

Janssen vaccine against coronavirus is a single-shot vaccine. It is produced by US-major Johnson and Johnson LLC. Janssen is also expected to be cleared for use in India in the following months. This vaccine is one of the first single-shot coronavirus vaccines developed so far (apart from Sputnik Light). Janssen was given emergency use nods in US and more recently in UK and EU. The approvals came from findings surfacing from clinical trials, which showcased that the vaccine delivered strong efficacy rate, at par with competitors. Reports and inputs from government sources have suggested that the central government is looking for speedy ways to import doses of the vaccine which could be used to inoculate the masses in a faster manner.

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US President Joe Biden announced vaccine distribution plans; Kamala Harris dialed New Delhi

U.S. President Biden

In a press briefing held on Thursday, US President Joe Biden announced the vaccine distribution plan. He announced the first details of the US sending 80 million Covid19 vaccines overseas with the stated aim of “ending the pandemic globally.”

The President stated that US will donate 75% of its unused vaccines against Covid19 to the UN-backed COVAX facility, which is facilitating distribution of vaccine to all people across the world.

The White House stated that out of the first tranche of 25 million doses, about 19 million will go to the COVAX, with around 6 million allocated for  South and Central America, 7 million allocated for Asia and 5 million for Africa. In Africa, US would be working in coordination with the African centre for Disease control and prevention. White House further stated that the remaining doses, just  over  6 million, will be shared directly with countries experiencing surges and other partners and neighbours including Canada, Mexico, Republic of Korea, Gaza, Ukraine, Kosovo, Haiti, Georgia, Egypt, Jordan, Iraq, Yemen, India as well as for United Nations frontline workers.

Also Read: Trends in US foreign policy- which archetype might Biden fit in

The US administration led by Joe Biden has been under a lot of pressure to provide vaccines and other necessary aid to various nations that have been hard-hit by the pandemic. Experts and observers from various organizations and countries have implored US administration to provide such hard-hit nations with its abundant supply of vaccines. At a White House briefing, National Security Adviser Jake Sullivan said that some of the initial doses would go to India, Gaza and the West Bank and other nations and areas facing crises.

In the statement, Biden stated that the first 25 million of the vaccines would be given to lay the ground for increased global coverage. White House pointed out that it aims to share 80 million doses globally by June-end, mostly through Covax. It added that 25% of the nation’s excess will be kept in reserve for emergencies and for the US to share directly with allies and partners.

President Biden added in the statement that as long as the pandemic is raging anywhere in the world, American people will still be vulnerable. He further added that US is committed to bringing the same urgency to international vaccination efforts that has been demonstrated inside US.

Also Read: The plausible link between the Abraham Accords & the Afghan peace process

NSA Jake Sullivan added that US will retain the say on where the doses distributed through Covax ultimately go.

Sullivan said, “We are not seeking to extract concessions, we are not extorting, we are not imposing conditions the way that other countries who are providing doses are doing; we are doing none of those things.”

He further added, “These are doses that are being given, donated free and clear to these countries, for the sole purpose of improving the public health situation and helping end the pandemic.”

Statement given by Biden also stressed that his administration supports temporary waiving of intellectual property rights for Covid19 vaccines.

Also Read: After he leaves the office Trump may be missed in the Middle-East-the testing ground for Biden’s foreign policy

In separate calls with Mexican President Andres Manuel López Obrador, President Alejandro Giammattei of Guatemala, Indian Prime Minister Narendra Modi and Prime Minister Keith Rowley of Trinidad and Tobago, US Vice President Kamala Harris informed that the countries will be receiving vaccine doses, beginning June-end. In the coming week, Vice president Harris would be visiting Guatemala and Mexico.

Many countries have requested vaccine doses from the United States. But till now, only Mexico and Canada have received a combined 4.5 million doses.

US administration also announced plans to share enough vaccine shots with South Korea to vaccinate its 550000 troops who are serving alongside American service members on the peninsula. One million shots of Jansen vaccine manufactured by Johnson & Johnson have been shipped to South Korea, on Thursday, said White House Covid19 coordinator Jeff Zients.

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US will work with COVAX to share vaccines; it intends to add to its vaccine manufacturing capacities

President Joe Biden said that US will be working with the WHO-backed COVAX facility and other partners for equitable distribution of around 80 million Covid19 vaccines. The vaccines would be provided from its stockpiles in line with Science and public health data gathered from around the world.  Biden is making good on his promise of making US an arsenal of the coronavirus vaccine-shots which are authorized by the FDA.

This gesture comes along with a clear intent of the US administration to augment & bolster its vaccine manufacturing capacities. The administration led by Joe Biden would be coordinating with the democracies around the world for a multilateral-effort in sharing of vaccines. In this regard, the POTUS is expected to announce the progress in the G-7 summit scheduled to be held in June, hosted by UK. On Monday, Biden had announced that US will share 20 million doses from its surplus stocks of the Pfizer, Moderna and Johnson & Johson vaccines by the June-end, which will be in addition to an earlier US commitment to share 60 million doses of AstraZeneca vaccines.

Also See: New mutants of Coronavirus

The vaccine diplomacy and cooperation would allow US manufacturers to hold or grow their share of the global market for vaccines, as signaled by Biden. This would allow the vaccine supply-chains to become an engine for creation of American jobs. Biden had cautioned that American contributions alone would not be able to resolve the crisis.

It is the first time that US administration has spoken officially about sharing of the vaccines that are authorized for use in the country. This move stems from the belief of Biden administration that it will have taken delivery of enough doses to protect everyone in the US by June.

Also Read: Issues faced by India in dealing with Covid 19 resurge- Is it too late to contain the Second Wave

The announcement by US came as India is reeling under the onslaught of the second wave of Covid 19 pandemic. On the world platform, as part of vaccine diplomacy, India had supplied around 60 million doses of vaccines to around 70 countries, and is now reeling under vaccine deficiency. In this context of making vaccines available for a larger number of people around the world, WHO has reminded Serum Institute of India of its commitment to Covax initiative. WHO chief Tedros Adhanom Ghebreyesus has said that once the devastating Covid-19 outbreak, i.e. the second wave in India recedes, the SII will need to “get back on track and catch up” on its delivery commitments to COVAX, the global initiative to supply coronavirus vaccines to nations around the world.

Also Read: Trends in Foreign Policy of post-Cold-War US -where Joe Biden might fit in

What is Covax

Covax, with which US would be working to share the vaccines with the world, is one of three pillars of the Access to Covid-19 Tools (ACT) Accelerator. The ACT was launched in April by the World Health Organization (WHO), the European Commission and France in response to the Coronavirus pandemic. Covax was designed to ensure that people in all corners of the world will get access to Covid -19 vaccines once they are available, regardless of their wealth.

COVAX will achieve this by acting as a platform that supports the research, development and manufacturing of a wide range of Covid-19 vaccine candidates, and negotiate their pricing. Covax approach is coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.

GAVI, (Global Alliance for Vaccines and Immunization) is a global health partnership, and has an observer status at the World Health Assembly, a forum through which the World Health Organization (WHO) is governed by its 194 member states.

As a public–private global health partnership with the goal of increasing access to immunization in poor countries, GAVI brings together developing countries, donor governments, the World Health Organization, UNICEF,  the World Bank, & the vaccine industry in both industrialized and developing countries. It also brings onboard the research and technical agencies, civil society, the Bill & Melinda Gates Foundation, and other private philanthropists to expand the vaccine outreach.

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Sanctions from the US preventing purchases of Covid19 vaccines, claims Iran

Covid19 vaccines, claims Iran

Officials in Tehran said that Iran’s attempts to procure vaccines to curb the worst outbreak of coronavirus in the Middle East are being hampered by U.S. sanctions. This is because the country is unable to utilize a payment system intended to ensure fair global access to the vaccine shots.

Iran had hoped to deploy funds worth billions of dollars locked up in South Korean Won-denominated accounts to help buy vaccines under an agreement reached with Seoul months ago.

However, the Central bank Governor Abdolnaser Hemmati said that the U.S. banking sanctions were effectively preventing Tehran from using the COVAX facility that is jointly managed by Geneva-based Gavi, the Vaccine Alliance, and the World Health Organization. Abdolnaser Hemmati said that the banks were unwilling to process transactions and convert the Won into dollars.

In a statement, a spokesperson for Gavi said that there was no “legal barrier” to Iran procuring vaccines through COVAX as the U.S. Treasury’s Office on Foreign Assets Control had issued a license covering coronavirus vaccine procurement.

A Million Cases

An Iranian government official said that the OFAC (Office of Foreign Assets Control) license had little effect. The money would have to be cleared through a U.S. bank in order to be converted into dollars and then into Euros before being transferred to COVAX, said the official, who asked not to be named because they are not authorized to speak on the matter.

South Korea has told Iran that it cannot provide an assurance that the money would not be seized or blocked when it is transferred to a U.S. bank, the official said.

So far, more than a million Iranians have contracted Covid19 and more than 50,000 have died in the pandemic. Officials say that the numbers significantly underestimate the true scale of the outbreak.

The Trump administration has reimposed sweeping economic sanctions on Iran from 2018 as it sought to force the country into a tougher agreement on its nuclear program, after having exited the nuclear agreement and attempting to downgrade its (Iran’s) presence in the Middle East. President-elect Joe Biden has vowed to re-engage with the Islamic Republic, triggering optimism in Tehran that sanctions could be removed.

Recently, the semi-official news agency- Mehr removed a report from its website that said that Iran’s Health Ministry was in talks with AstraZeneca Plc to secure 20 million doses of a coronavirus vaccine that it has been developing with Oxford University.

Iran is preparing to start human trials of its own vaccine, which has been renamed after a top nuclear scientist, Mohsen Fakhrizadeh, assassinated late last month. While the vaccination against Covid19 has begun in the UK, with efforts made by China to place its Sinopharm vaccine in the Middle East, the vaccine in Iran is expected to be available next summer.

The author is a student member of amity centre of happiness

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Gates foundation ties up with Pune Serum Institute for 100 million Covid19 vaccines

After the deal with the American based vaccine developer – Novavax, the Serum institute of Pune has finalised a deal with the Gates Foundation and Gavi, the global vaccine Alliance. The deal has been made for 100 million doses of Covid19 vaccine for India as well as other low and middle income category countries (LMICs) by the year 2021.

The Gates foundation would provide at risk funding of $ 150 million to GAVI, which will then finance the Serum Institute (SII) to manufacture the vaccines. Gavi stands for global alliance for vaccines and immunisation, a public- private global health partnership with important contributions and inputs from the World Bank, the World Health Organization and UNICEF. To obtain the vaccine for other low and middle income countries, Gavi’s Covax AMC will work with the Serum institute. AstraZeneca and Novavax, the candidate vaccines from the Oxford University would be procured using the funding after getting required licences and WHO pre-qualifications. Subsequently the SII would start manufacturing the vaccine. A price ceiling has been kept at $3(approx. INR 225).

It should not be surprising given India’s track record in delivering high quality low cost research in medical field. In June, Gavi Covax AMC(Advanced Market Commitment), a financing instrument was launched to boost the production of sufficient number of vaccines for the LMICs. As of now, it is looking for a seed fund of $2 billion after finalising the list of 92 countries where it will make the vaccine available. If the AstraZeneca vaccine is successful, GC AMC will make it available in 57 countries which are Gavi eligible. If the Novavax is successful, then AMC will make it available to all the 92 countries. Any country’s gross national income data as available from World Bank sources determines whether it is Gavi eligible or not. Drugs controller general of India has already given a green signal to Serum institute to conduct Phase II and Phase III human clinical trials of the AstraZeneca candidate vaccine.