Covid-19 vaccine for children under 12 years now awaiting approval5 min readReading Time: 4 minutes
A vaccine against Covid-19 for children is being developed by Gujarat-based pharmaceutical company Zydus Cadila. The company sought emergency-use approval from the Drugs Controller General of India (DCGI) on July 1, but it seems like the official go-ahead for the vaccine for public use will take a few more days. Meanwhile, let’s learn all about ZyCoV-D – a DNA vaccine.
Safe for children
ZyCoV-D reached Phase-III clinical trials using over 28,000 volunteers, and is said to have demonstrated safety and efficacy. The data has shown that ZyCoV-D is safe for children in the age group of 12 to 18 years, said the company, which is planning to manufacture 100-120 million doses of the vaccine annually.
Owliver’s Obscure Observations
If given approval, ZyCoV-D would become the fifth vaccine cleared for use in the country, after locally produced Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna
The study was carried out “during the peak of the second wave of Covid-19 in India, reaffirming the vaccine’s efficacy against the new mutant strains, especially the Delta variant,” Zydus said in a statement.
Delta is the name for the B.1.617.2. variant, a Covid mutation that originally surfaced in India. The first Delta case was identified in December 2020, and the strain spread rapidly, soon becoming the dominant strain of the virus in both India and then Great Britain. Toward the end of June 2021, Delta had already made up more than 20% of cases in the US. The World Health Organization has called this version of the virus “the fastest and fittest.”
DNA vaccine? What’s that?
ZyCoV-D will become the world’s first DNA vaccine to get the nod in any country. What exactly does this mean though? ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2, and brings about an immune response to it. Plasmids are a type of DNA found mostly in bacteria. These vaccines prove more versatile and easier to store at higher temperatures.
According to the World Health Organisation (WHO), this “radical new approach” offers several advantages over traditional vaccines, which include “improved vaccine stability, the absence of any infectious agent and the relative ease of large-scale manufacture.”
No poke, no pain
Another aspect that makes the ZyCoV-D vaccine unique is that it can be administered without an injection! It will use a fluid jet that penetrates the skin—which the company says is painless and could reduce side effects from the jab. The company says it uses the PharmaJet needle-free system Tropis. PharmaJet, a Colorado-based company, says it is a “single-use, sterile, disposable syringe used with a reusable injector”.
The advantages are reduced injuries from needles and reduced waste generated since there is no needle in the process. This will also be beneficial for children, as they tend to be afraid of needles.
Owliver’s Obscure Observations
While this injection-free vaccination method may seem like a new discovery into the world of vaccines, it is an old technique, first demonstrated in 1866. This method of vaccination was also used during the 1960s for smallpox vaccination drives.
Most Covid-19 vaccines currently are given in two doses, with a couple of single-shot ones also available. ZyCov-D by contrast, will be given in three doses, with an interval of 28 days between the first and second and second and third shots.
According to data from the trials conducted, two doses of the vaccine seem to be enough to prevent people from developing severe symptoms of Covid-19 and to prevent death, while three doses keep even moderate symptoms at bay.
However, experts say that there just isn’t enough data that has been made public regarding the safety of the vaccine. Data from phase-II of the trials is yet to be published, and the data from third trial could take a while before it is out in the public domain.
Have you read our three-part series on Covid-19 vaccines yet? The in-depth pieces will take you through the different kinds of vaccines, how they are made, and which one is right for you. Give it a read!
What happens next?
The DGCA will go through Zydus Cadila’s application for restricted emergency use permission or authorisation (known as EUA in other countries). Then, a meeting will be held and the company will present the data and make its case for an EUA.
Based on the data submitted and presented, it will be decided whether the vaccine should be recommended for an EUA. It will also look into details such as whether there is sufficient data to back the use of this vaccine among those between the ages of 12 and 18 years.
Sources say the vaccine could hit the shelves as early as next month!
Sources: Hindustan Times, Mint, Indian Express, Times of India