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India: Covaxin approval: All you need to know about Bharat Biotech Covid-19 vaccine’s efficacy, price | Hindustan Times.

[Jan 02, 2021, 22:00 IST]

Bharat Biotech followed a double-bind, randomised, multi-centre phase two clinical trial which included children as well. Its third phase trial is still going on.

Apart from Oxford/Astrazeneca vaccine, the other vaccine candidate that is all set to get restricted emergency-use approval in the coming days is Bharat Biotech’s Covaxin. The subject expert panel of India’s drug regulator on Saturday has recommended it for emergency use. While the final nod rests with the Drug Controller General of India (DCGI), Covaxin moving a step closer to getting approval carries major significance for India in the global scenario as 10 countries have already shown interest in India’s first home-grown vaccine. 10 million doses of the vaccine have already been produced for the Indian market.

Here is all you need to know about this vaccine:

Made-in-India vaccine: This is the first made-in-India vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.

Inactivated vaccine.

An inactivated vaccine is one which is developed by inactivating (killing) the live microorganisims that cause the disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response. There are many inactivated vaccines against Hepatitis A, Influenza, Polio, Rabies, which offer “excellent protection”, Bharat Biotech has said.

Expert panel recommends Bharat Biotech’s Covaxin for restricted emergency use

Covaxin’s efficacy as proved in animal studies.

Bharat Biotech in its report published after animal studies said that its vaccine candidate showed protective efficacy. The vaccine candidate was administered in 20 rhesus macaques, divided in four groups. One group was administered with placebo, while three other groups were immunised with three different vaccine candidates. “To summarize, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus,” it said.

Covaxin’s human clinical trial outcomes.

The third phase of trial is still going on, while the company has already published the findings of the first two rounds. It followed a double-bind, randomised, multi-centre phase two clinical trial which included children as well.

Efficacy to be determined only after two shots.

After Haryana minister Anil Vij tested positive after receiving one dose of the vaccine during the trial, the company clarified that the efficacy is to be determined only after 14 days post the second dose. Also, as its trial was random in which some received the vaccine and some received placebo, there was no way to know whether the minister received a vaccine shot or a placebo shot.

Price.

Union health minister Dr Harsh Vardhan has on Saturday clarified that the first phase of vaccination which will include frontline workers will be free. There has been no talk on the price of Covaxin though Dr Krishna Ella, the MD of Bharat Biotech, earlier said that the vaccine will be cheap, cheaper than a water bottle, he had said in a conference, pointing to a water bottle. Since his comment, it has been estimated that it will come at a cost lower than Rs 100.

Investment.

According to reports, Bharat Biotech’s total investment is about Rs 350-400 crore for the development of the vaccine, including new manufacturing facilities, investment for trials etc.

Covaxin in other countries.

Bharat Biotech has already signed a letter of intent with US firm Ocugen to co-develop Covaxin for the US market. The company was also in talks with 10 countries in South America, Asia and Central Asia, and Eastern Europe.


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The Structure, Function, and Mechanisms of Action of Enterovirus Non-structural Protein 2C | Virology | Frontiers in Microbiology.

[ Open Access] [Received: 10 October 2020; Accepted: 23 November 2020; Published: 14 December 2020]

Abstract.

Enteroviruses are a group of RNA viruses belonging to the family Picornaviridae. They include human enterovirus groups A, B, C, and D as well as non-human enteroviruses. Enterovirus infections can lead to hand, foot, and mouth disease and herpangina, whose clinical manifestations are often mild, although some strains can result in severe neurological complications such as encephalitis, myocarditis, meningitis, and poliomyelitis. To date, research on enterovirus non-structural proteins has mainly focused on the 2A and 3C proteases and 3D polymerase. However, another non-structural protein, 2C, is the most highly conserved protein, and plays a vital role in the enterovirus life cycle. There are relatively few studies on this protein. Previous studies have demonstrated that enterovirus 2C is involved in virus uncoating, host cell membrane rearrangements, RNA replication, encapsidation, morphogenesis, ATPase, helicase, and chaperoning activities. Despite ongoing research, little is known about the pathogenesis of enterovirus 2C proteins in viral replication or in the host innate immune system. In this review, we discuss and summarize the current understanding of the structure, function, and mechanism of the enterovirus 2C proteins, focusing on the key mutations and motifs involved in viral infection, replication, and immune regulation. We also focus on recent progress in research into the role of 2C proteins in regulating the pattern recognition receptors and type I interferon signaling pathway to facilitate viral replication. Given these functions and mechanisms, the potential application of the 2C proteins as a target for anti-viral drug development is also discussed. Future studies will focus on the determination of more crystal structures of enterovirus 2C proteins, which might provide more potential targets for anti-viral drug development against enterovirus infections.


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Impact of COVID-19 Pandemic on Global Poliovirus Surveillance | Morbidity and Mortality Weekly Report (MMWR) | Centers for Disease Control and Prevention.

[Open Access] [January 1, 2021 / 69(5152);1648–1652]

Summary.

What is already known about this topic?

Surveillance for acute flaccid paralysis (AFP) is critical to detecting poliovirus circulation. Environmental (sewage) surveillance supplements AFP surveillance in many locations.

What is added by this report?

Poliovirus surveillance activities were modified as a result of the COVID-19 pandemic. Reported AFP cases declined 33% from January to September of 2020 compared with the same period in 2019, and the number of environmental samples per site declined. The decline in polio surveillance coincided with the spread of COVID-19.

What are the implications for public health practice?

Interruptions to poliovirus surveillance might have negative consequences on detection of poliovirus circulation. Continued analysis of AFP reporting trends is necessary to better understand the long-term impact to the eradication initiative . The Global Polio Eradication Initiative remains committed to global polio eradication.


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Podcast and Video: TWiV 700: ‘Twas COVID and the aerosols | This Week in Virology.

[Published December 31, 2020; Recorded December 30th, 2020]

TWiV 700: ‘Twas COVID and the aerosols

TWiV reviews additional data on the UK variant of SARS-CoV-2, the distinct variant spreading in South Africa, association of afucosylated antiviral IgG with severe COVID-19, approval of AstraZeneca vaccine in the UK, and winners of the pandemic poem contest.

Hosts: Vincent Racaniello, | Rich ConditKathy Spindler, and Brianne Barker

Watch 'virtual roundtable'; discussion on YouTube video [2:11:41]: https://youtu.be/yeeFXBhi-O4

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Listen to Podcast via source article

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Download TWiV 700 (82 MB .mp3, 136 min)
Subscribe (free): iTunesGoogle PodcastsRSSemail

Become a patron of TWiV!

Links for this episode

Weekly Picks 1:57:24

Brianne – Ready Player Two
Kathy – Bert Hubert’s Reverse Engineering of the Pfizer/BioNTech vaccine
Rich – Boston Dynamics running robots
Vincent – Fever by John Fuller

Intro music is by Ronald Jenkees

Send your virology questions and comments to twiv@microbe.tv


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