After months waiting for new shots to join the ranks of Covishield, Covaxin and Sputnik V and augment India’s vaccine arsenal in the Covid-19 fight, this week came as a boost as the Centre okayed the rollout of a vaccine from the US and Indian drugmaker Zydus Cadila said it was applying for an emergency use nod in the country. In other news, there was more clarity on Indian vaccines and travel to Europe.
Move Over Two: Zydus Ready With Three-Shot Vax
The Ahmedabad Zydus Cadila on July 1 sought approval from the Drug Controller General of India (DCGI) for emergency launch of its plasmid DNA, ZyCoV-D vaccine in India. The nucleic acid vaccine is the first in the world based on the DNA platform. There have been no DNA vaccines so far that have been approved for human use.
Amid the rise of the Delta and Delta-plus variants and the concern they have triggered about a third wave being on its way, the company said that trials of the vaccine were held “across the country and during the peak of second wave… reaffirming the vaccine’s efficacy against the new mutant strains”. In another positive, this vaccine was also tested on and found to be safe for the 12-18 year age group.
The company said it recorded preliminary efficacy of 66.6 per cent against “symptomatic RT-PCR positive cases”. It added that no moderate Covid-19 case was observed for those who received the third dose of the vaccine, “suggesting 100 per cent efficacy for moderate disease”. Also, “no severe cases or deaths due in the vaccine arm after administration of the second dose of the vaccine”, the company added.
The production capacity is for 10-12 crore doses annually, Zydus Cadila said. At three doses for full vaccination, that will cover about 4 crore individuals. Interestingly, the company said it has also trialled a two-dose regimen for the vaccine and “results had been found to be equivalent to the current three-dose regimen”. It noted that it “will further help in reducing the full course duration of vaccination”.
Another highlight is that ZyCoV-D is an intradermal vaccine, which are administered via a shallow injection into the dermis, which is located between the epidermis and the hypodermis. Also, the vaccine can be stored at 2-8 degrees Celsius, but the company has said it “has shown good stability at temperatures of 25 degrees Celsius for at least three months”. That could mean it is easier, logistically speaking, to store and move the vaccine.
ZyCoV-D, once okayed, will be India’s second indigenously produced Covid-19 shot after Covaxin.
Moderna’s mRNA Jab To Reach India In Days
As the second wave was tearing through the country, the Centre had said it would provide expedited approvals for certain foreign-made vaccines to launch in India. However, regulatory, legal and infrastructural issues had proved to be hurdles in the way of their launch in the country with the likes of Pfizer and Moderna, both based in the US, seeking legal indemnity and trial waivers as precondition to selling their vaccines in India.
But the picture changed with the Centre announcing that it has extended an emergency launch nod to Moderna. The first doses are, in fact, expected to reach India in the coming week with Cipla, the company’s Indian partner, to be in charge of importing the vaccine before they are distributed by the Centre.
The Moderna vaccine had an efficacy rate of 94.1 per cent in preliminary clinical trials and the real-world effectiveness of this jab has been measured at over 90 per cent. The vaccine makers have also said that it provides protection against the newer variants of the novel coronavirus.
EU Clears Air On Indian Jabs For Restriction-Free Travel
The European Union (EU) on July 1 rolled out its Digital Covid Certificate plan to enable greater ease of travel during the pandemic. The initial announcement had said that when it comes to vaccines, the only jabs it would recognise are the ones cleared by the European Medical Agency (EMA). That caused anxiety among Indians seeking to travel to the continent as none of the vaccines being used in the country have received an emergency nod from the European drug regulator.
The fact that the same AstraZeneca vaccine — which is being used in India as Covishield — under the brand name VaxZevria was recognised in EU but not Covishield only added to the confusion and saw Serum India CEO Adar Poonawalla, whose company makes Covishield under licence in India, step in to say that the matter of the Covid passport would be taken up at the highest levels.
Reports now say that at least 10 European countries, including EU members like Germany and the Netherlands, are accepting Covishield as a valid vaccine for the purposes of the Covid-19 passport. India is further said to have told the EU countries that it will pursue a policy of reciprocity to allow vaccinated people from EU countries to travel to India only if their governments recognise the Indian vaccines.
The EU’s Digital Covid Certificate, or the so-called ‘Green Pass’, is intended to “facilitate safe free movement of citizens in the EU during the Covid-19 pandemic”. The certificate essentially details a traveller’s Covid-19 status. It is a “digital proof” that a person has either been vaccinated, tested negative within a stipulated timeframe, or recovered from a bout of Covid-19.
But the European Commission (EC) has clarified that the digital certificate “will not be a pre-condition to free movement, which is a fundamental right in the EU”. Having said that member States have been advised to “accept vaccination certificates for vaccines which received EU marketing authorisation” although the commission also says that the certificate can be extended “also to EU travellers that received another vaccine”.