This Week, the
Food and Drug Administration granted emergency authorization to two new vaccines Corbevax and
Covovax and the
drug Molnupiravir for treatment of adult patients with Covid-19, a major
milestone that promises to revolutionize the fight against the virus.
With this approval, there
are now eight Covid vaccines in the country that have gotten EUA. Six Covid-19
vaccines have already received EUA from the Indian pharma regulator: Serum
Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D,
Russia’s Sputnik V, and the US-made Moderna and Johnson and Johnson.
Corbevax
The Corbevax vaccine,
developed by the Hyderabad-based firm Biological-E, is India’s first
indigenously developed RBD protein sub-unit vaccine against #COVID19.
A protein subunit
vaccination employs pieces of the virus to elicit an immune response rather
than the entire virus. The subunit vaccination in this case comprises a safe S
protein. When the immune system recognises a protein, antibodies are created to
fight the infection when it occurs.
Texas Children’s Hospital
Centre for Vaccine Development created the antigenic portions of the virus,
which were in-licensed from BCM Ventures (Baylor College of Medicine).
Biological E wants to start producing 75 million doses per month in January and
expects to reach 100 million doses per month by February.
At 33 research sites across
India, Biological E has completed Phase III studies on over 3,000 participants.
According to the report, neutralising Delta strain antibody titres “indicates
a vaccination efficacy of more than 80% for the prevention of symptomatic
illnesses based on published trials.”
Covavax
Covavax is a protein subunit
vaccine made by Serum Institute of India (SII), however it uses recombinant
nanoparticle technology. Novavax, a company based in the United States,
developed it. Insect cells are used to generate non-harmful copies of the spike
protein, which is then removed and assembled into virus-like nanoparticles.
Novavax has made use of an immune-boosting substance (adjuvant). HPV and the
Hepatitis B vaccine both employ the same technology
It is given intramuscularly
in a two-dose regimen on Days 0 and 21. The vaccine is available in 0.5 mL
(single dose) and 5 mL (10 doses) vial packs and is kept at 2 to 8 degrees
Celsius.
In two phase 3 studies in
the UK and the US/Mexico, the vaccine showed 96.4 percent effectiveness against
the original strain, 86.3 percent against Alpha, and 89.7% overall (UK), as
well as ‘100 percent protection against moderate and severe illness’ with 90.4
percent protection.
Molnupiravir
Molnupiravir, a
medication created by Ridgeback Biotherapeutics in conjunction with Merck in
the United States, will now be produced by 13 Indian pharmaceutical companies. In
India, the medicine has been approved for the treatment of people with Covid-19
who “have a high risk of disease progression.”
Molnupiravir is
an antiviral tablet that stops the SARS-CoV-2 virus from multiplying further by
inserting faults into its genetic coding. Molnupiravir is used orally in four
200-mg capsules every 12 hours for five days, totaling 40 capsules.
The medication
will be produced in India by 13 different companies. The medicine will be
manufactured by Dr. Reddy Laboratories, Cipla, Natco Pharma, Optimus Pharma Pvt
Ltd, Stride, and Hetero, among other prominent pharmaceutical companies.
