Moderna’s Covid vaccine approved for use in India
India on Tuesday approved the import of US pharmaceutical major Moderna’s mRNA technology-based coronavirus disease (Covid-19) vaccine, paving the way for the entry of the first international vaccine against the infectious disease into the country.
On behalf of Moderna, Indian pharmaceutical company Cipla Ltd applied to the country’s drugs regulator, the Drugs Controller General of India, for grant of approval to import the vaccine to India.
“An application received from Moderna through an Indian partner of theirs, namely Cipla, has been granted new drug permission for restricted use that is commonly known as emergency use authorisation. This is the first internationally developed vaccine for which now such permission exists today, and this potentially opens up a clear possibility of this vaccine being imported into India in the near future. Let’s see how this opportunity will be used for accessing the vaccine in the country. There must be other formalities that they will have to follow but a very important licensure has been given,” said Dr VK Paul, member (health), Niti Aayog, during the Union health ministry’s media briefing on Covid-19 updates.
Moderna is donating an unspecified number of doses to India through the World Health Organization (WHO) and Gavi’s COVAX mechanism; Cipla is facilitating this, and the approvals are part of the process. In a statement, Cipla said it is “supporting Moderna with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies.” It wasn’t clear how many doses will be imported, and when.
An official said the approval was not limited to donations. “Cipla has been given a licence to import, and it is applicable to the Moderna vaccine import in general, under which they are also allowed to distribute it here; since it is still under emergency use authorization retail sale of the product is not allowed. It does not matter whether the doses are a part of some donation or otherwise being exported by the US company, Cipla is now authorized to import the Moderna vaccine,” the official aware of the matter in the Central Drugs Standard Control Organisation (CDSCO) said on condition of anonymity.
“Even though it is totally up to them how much they want to import and when, it is likely that about 7 million doses are imported, and the process should start in next 5-6 days. Moderna has definitely got the first mover advantage...,” the official added.
In a statement, Moderna said the government of India issued a registration certificate and a permission to import the Covid-19 vaccine for restricted use in an emergency situation. “I want to thank the government of India for this authorization, which marks an important step forward in the global fight against the pandemic,” a statement by the company’s CEO said.
Previously, news reports in May, citing unnamed people, said Cipla was considering spending up to $1 billion to import 50 million doses of the vaccine. HT learns that Cipla has also sought indemnity for the Moderna vaccine, much like other international vaccine makers negotiating their entry into India. The government is yet to take a call on indemnity for any foreign vaccine maker.
“Moderna is coming in the ready-to-inject form. There is no manufacturing base as of now, like in case of Sputnik V, but we also hope that in the future, Moderna will produce this vaccine on Indian soil; and make this, therefore, into a made-in-India vaccine. There will be no need for a bridging study that has been already clarified, but recipients of first 100 doses of the vaccine will be closely watched. So, now there are four Covid-19 vaccines approved: Covaxin, Covishield, Sputnik and Moderna; our vaccine basket is now richer by this addition,” Paul added.
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The vaccine, mRNA-1273, manufactured by Moderna TX, Inc., is a two-dose vaccine with the shots to be given 28 days apart. Messenger RNA vaccines, also called mRNA vaccines, are a new vaccine technology platform.
The vaccine can be stored for up to seven months between -25 and -15 degrees Celsius; and its medium-term storage temperature is -20 degrees. In normal cold chains, where the temperature is between 2 and 8 degrees Celsius, an unopened vial can stay effective for 30 days.
The mRNA vaccines teach human cells how to make a protein, or even just a piece of a protein of the virus, triggering an immune response inside human bodies. The benefit of mRNA vaccines, like all vaccines, is that those vaccinated gain protection without ever having to risk the serious consequences of getting sick with Covid-19.
According to the evidence generated through clinical trials, in people aged 18 years and older, the Moderna vaccine was 94.1% effective at preventing laboratory-confirmed Covid-19 infection.
Experts welcomed the clearance of an mRNA vaccine.
“There are likely going to be small numbers for next many months, so unlikely (to be a) major contribution to public health. But it is very valuable as a process and for a small group of people for whom other vaccines may not work well,” said Dr Gagandeep Kang, physician-scientist, Christian Medical College, Vellore, Tamil Nadu.
In early June, after reports of a partnership with Moderna surfaced, Cipla said in a statement that it is “in the process of seeking clarity and guidance from the Government of India for exploring the possible road map for vaccine importation to India.” “At this stage, no definitive terms have been finalized and hence, the Company cannot comment further,” read the company statement.
Paul also mentioned during the media briefing that the government was making necessary efforts to also bring in other foreign vaccines to India and that the sticky indemnity issue is under consideration and examination.
“Our efforts to invite, and to have other internationally developed vaccines, specifically Pfizer and J&J, continue. Those processes are on, and we are also looking at increased production, and availability, of our own vaccines that are being manufactured already in our country. We look forward to the vaccination programme gaining further momentum.”
“We have had multiple sessions with Pfizer; going through the agreements that are required for such an arrangement to be operationalised, and exchange of information and thoughts, and inputs are going back and forth. The process is very much on and we have done an intensive meeting last week. We are looking forward to receiving the feedback from their end now,” he added.
In an emailed response, a Pfizer company spokesperson said: “We continue to engage with the government to make our Pfizer-BioNTech vaccine available for use in the country.”
A Johnson & Johnson India spokesperson said: “At Johnson & Johnson, we remain fully focused on bringing a safe and effective COVID-19 vaccine to people in India. We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our Janssen single dose COVID-19 vaccine to India.”
J&J already has a manufacturing tie-up with Biological E, which is also making a protein sub-unit vaccine of its own.
To facilitate the entry of foreign made vaccines into India, the government earlier made regulatory modifications.
On June 2, the national drugs controller announced that Covid-19 vaccines approved by specific countries and WHO would no longer require post-approval bridging trials and batch testing in India.
“If the vaccine has been certified and released by the national control laboratory of certain countries or if it is listed in the WHO Emergency Use Listing (EUL), it can be exempted from the aforementioned requirement,” stated a letter issued by CDSCO that is headed by the drugs controller.
However, additional scrutiny and review shall continue, DCGI said, and before the vaccine is rolled out for further immunisation programmes, the first 100 beneficiaries shall be assessed for seven days for safety outcomes, along with other procedures for the filing of applications and timelines.