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Covaxin

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Vorlage:Short description Vorlage:Use Indian English Vorlage:Use dmy dates Vorlage:Infobox drug

Vorlage:COVID-19 pandemic sidebar

BBV152 (also known as Covaxin) is an inactivated virus based COVID-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.

Clinical research

Phase I and II trials

In May 2020, Indian Council of Medical Research's (ICMR's) National Institute of Virology approved and provided the virus strains for developing a fully indigenous COVID-19 vaccine.[1][2] In June 2020, the company got permission to conduct Phase 1 and Phase 2 human trials of a developmental COVID-19 vaccine named Covaxin, from the Drugs Controller General of India (DCGI), Government of India.[3] A total of 12 sites were selected by the Indian Council for Medical Research for Phase I and II randomised, double-blind and placebo-controlled clinical trials of vaccine candidate.[4][5][6]

In December 2020, the company announced the report for Phase I trials and presented the results through medRxiv preprint.[7][8][9]

Phase III trials

In November 2020, Covaxin received the approval to conduct Phase III human trials[10] after completion of Phase I and II.[11] The trial involves a randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above and started on 25 November.[12] The Phase III trials will involve around 26,000 volunteers from across India.[13] The phase III trials will cover a total of 22 sites consisting several states in the country, including Delhi, Karnataka and West Bengal, and many other states are expected to join soon.[14] Refusal rate for Phase III trials was much higher than that for Phase I and Phase II. As a result only 13,000 volunteers had been recruited by 22 December with the number increasing to 23,000 by 5 January.[15][16][17]

Manufacturing

Bharat Biotech is producing the vaccine candidate via at-risk manufacturing at their vero cell manufacturing platform[18] that has the capacity to deliver about 300 million doses.[19] The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm is in talks with other state governments like Odisha[20] for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.[21]

In December 2020, Ocugen Inc entered a partnership with Bharat Biotech to co-develop Covaxin for the U.S. market.[22][23]

In January 2021, Precisa Med entered an agreement with Bharat Biotech to supply Covaxin in Brazil[24]

Emergency use authorisation

Vorlage:See also Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (Vorlage:Abbr).[25] It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.[26]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for Vorlage:Abbr,[27] which was granted on 3 January.[28] The emergency approval was given before Phase III trial data was published. This was critized in some sections of the media.[29][17]

See also

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References

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Vorlage:Vaccines Vorlage:COVID-19 pandemic in India Vorlage:Portal bar

  1. ↑ ICMR teams up with Bharat Biotech to develop Covid-19 vaccine In: Livemint, 9 May 2020 (englisch). 
  2. ↑ India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech In: ThePrint, 10 May 2020 
  3. ↑ India's First COVID-19 Vaccine Candidate Approved for Human Trials In: The New York Times, 29 June 2020 
  4. ↑ Human clinical trials of potential Covid-19 vaccine ‘COVAXIN’ started at AIIMS In: DD News, Prasar Bharati, Ministry of I & B, Government of India, 25 July 2020 
  5. ↑ Associated Press: Asia Today: Amid new surge, India tests potential vaccine In: Washington Post, 25 July 2020. Abgerufen im 17 December 2020 
  6. ↑ Delhi: 30-year-old is first to get dose of trial drug Covaxin In: The Indian Express, 25 July 2020 (englisch). 
  7. ↑ Raches Ella, Krishna Mohan, Harsh Jogdand, Sai Prasad, Siddharth Reddy, Vamshi Krishna Sarangi, Brunda Ganneru, Gajanan Sapkal, Pragya Yadav, Samiran Panda, Nivedita Gupta, Prabhakar Reddy, Savita Verma, Sanjay Rai, Chandramani Singh, Sagar Redkar, Chandra Sekhar Gillurkar, Jitendra Singh Kushwaha, Venkat Rao, Satyajit Mohapatra, Randeep Guleria, Krishna Ella, Balram Bhargava: Safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152: a phase 1, double-blind, randomised control trial. In: medRxiv. 15. Dezember 2020, doi:10.1101/2020.12.11.20210419 (englisch, medrxiv.org).
  8. ↑ Bindu Shajan Perappadan: Coronavirus | Covaxin phase-1 trial results show promising results In: The Hindu, 16 December 2020. Abgerufen im 17 December 2020 (indisches Englisch). 
  9. ↑ Harshit Sabarwal: Covaxin’s phase 1 trial result shows robust immune response, mild adverse events In: Hindustan Times, 16 December 2020. Abgerufen im 17 December 2020 (englisch). 
  10. ↑ Coronavirus | Covaxin Phase III trial from November In: The Hindu, 23 October 2020 (indisches Englisch). 
  11. ↑ Ganneru B, Jogdand H, Daram VK, Molugu NR, Prasad SD, Kannappa SV, Ella KM, Ravikrishnan R, Awasthi A, Jose J, Rao P: Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152. 9. September 2020, doi:10.1101/2020.09.09.285445.
  12. ↑ An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers. In: clinicaltrials.gov. United States National Library of Medicine, abgerufen am 26. November 2020 (NCT04641481).
  13. ↑ Bharat Biotech begins Covaxin Phase III trials In: The Indian Express, 18 November 2020 (englisch). 
  14. ↑ List of states that have started phase 3 trials of India's first Covid vaccine In: mint, 2 December 2020 (englisch). 
  15. ↑ 70%-80% Drop In Participation For Phase 3 Trials Of Covaxin: Official In: NDTV, 17 December 2020 
  16. ↑ Bharat Biotech’s Covaxin given conditional nod based on incomplete Phase 3 trial results data In: The Print, 3 January 2021 
  17. ↑ a b Covaxin phase-3 trials to end today, average efficacy 60-70% In: Deccan Herald, 5 January 2021 
  18. ↑ Hoeksema F, Karpilow J, Luitjens A, Lagerwerf F, Havenga M, Groothuizen M, Gillissen G, Lemckert AA, Jiang B, Tripp RA, Yallop C: Enhancing viral vaccine production using engineered knockout vero cell lines - A second look. In: Vaccine. 36. Jahrgang, Nr. 16, April 2018, S. 2093–2103, doi:10.1016/j.vaccine.2018.03.010, PMID 29555218.
  19. ↑ Coronavirus vaccine update: Bharat Biotech's Covaxin launch likely in Q2 of 2021, no word on pricing yet In: www.businesstoday.in. Abgerufen im 13 December 2020 
  20. ↑ Odisha fast tracks coronavirus vaccine manufacturing unit In: The New Indian Express, 7 November 2020 
  21. ↑ Bharat Biotech exploring global tie-ups for Covaxin manufacturing In: The Indian Express, 24 September 2020 (englisch). 
  22. ↑ Reuters Staff: Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S. In: Reuters, 22. Dezember 2020. Abgerufen am 5. Januar 2021 (englisch). 
  23. ↑ Bharat Biotech, Ocugen to co-develop Covaxin for US market In: The Economic Times. Abgerufen am 5. Januar 2021 
  24. ↑ Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil In: mint, 12 January 2021 (englisch). 
  25. ↑ Bharat Biotech seeks emergency use authorization for Covid-19 vaccine In: Hindustan Times, 7 December 2020 (englisch). 
  26. ↑ Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin In: The Hindu, 7 December 2020 (indisches Englisch). 
  27. ↑ Expert panel recommends granting approval for restricted emergency use of Bharat Biotech’s Covaxin In: The Indian Express, 2 January 2021 (englisch). 
  28. ↑ Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca In: BBC News, 3. Januar 2021 (britisches Englisch). 
  29. ↑ Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out. In: The Wire. 12. Januar 2021;.
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