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The deadly health crisis caused by covid-19 has unleashed a frantic race against time to develop a vaccine, with progress much faster than any previous effort.
While 83 companies around the world compete to develop a vaccine, six have already advanced to human trials or the clinical evaluation stage, with 77 in the preclinical evaluation phase on April 23, according to the World Organization’s database. Health (WHO).
That is an unprecedented pace. The mumps vaccine, the fastest to reach the markets, took four years to obtain a license in 1967, according to National Geographic.
Zydus Cadila, Serum Institute of India, Biological E, Bharat Biotech, Indian Immunologicals Ltd and Mynvax are among the local companies trying to develop a vaccine for covid-19.
In line with the rapid global response to develop a vaccine for covid-19, the General Drug Controller of India (DGCI) amended its 2019 Clinical Trial Rules, saying it will forgo clinical trials on people in India and approve any medication or Covid-19 vaccine that is approved in any other country.
However, according to DGCI regulations, newer drugs can only be approved, from the USA. The USA, Japan, Australia, Canada and the European Union, if they have included patients of Indian origin in their studies.
“Due to an emergency situation arising from the pandemic, if any drug or vaccine is approved by any drug regulatory agency in any country for covid-19 after guaranteeing its safety and efficacy, we will approve it through the accelerated mechanism avoiding the clinical trials on the Indian population on a case-by-case basis, “said a senior DGCI official on condition of anonymity.
The regulator has not received any such requests for clinical trials, the official said. DGCI has so far approved three applications related to covid-19, comprising the Serum Institute of India, which is working on a preventive vaccine, Zydus Cadila’s candidate for immune response for three trials, and Biocon for test kits.
The normal time frame for developing a vaccine varies from 10 to 15 years, but the covid-19 vaccine is likely to be available in about a year with several companies joining forces to accelerate efforts to develop a vaccine against the deadly disease.
CanSino Biological Inc. of China / Beijing Biotechnology Institute, Beijing Biological Products Institute / Wuhan Biological Products Institute, Sinovac, US-based Inovio Pharmaceuticals. The US, Moderna / NIAID and the University of Oxford, UK, have already entered the phase of testing human vaccines.
“The world has seen many diseases emerge before, but covid-19 has been different because there is a rapid response to the vaccine,” said Dr. Gagandeep Kang, head of the working group of the Indian Council for Medical Research (ICMR). in covid- 19 vaccines.
“H1N1 was a pandemic, but there was H1N1 many years ago, so there may be partial protection and the disease was relatively mild,” said Dr. Kang, adding that deaths and covid-19 cases will increase until let’s have medications for treatment. or vaccines for prevention.
Explaining the reasons why a vaccine may be ready by the end of 2021, experts said that since covid-19 is caused by coronaviruses that are also responsible for other respiratory diseases such as Middle East respiratory syndrome (Mers) and respiratory syndrome acute severe (Sars), companies were already working on vaccines for these diseases. “For vaccine development, you need funding, knowledge, capacity, vaccine candidates, partnerships. Efforts have already been made to develop a Sars-CoV-2 and Mers-CoV vaccine that were caused by other coronaviruses. Because of this, covid-19 could be tracked quickly, “said Dr. Naveen Thacker, former GAVI Board member, Vaccine Alliance is a public-private global health association committed to increasing access to immunization in poor countries .
Shortly after the new coronavirus outbreak, China shared the sequence of Sars-CoV-2 (covid-19) genetic material that could pave the way for developing a vaccine for covid-19. Dr. Sanjay Mehendale, a member of the National Biopharma Mission’s scientific advisory group on covid-19 research and co-chair of the clinical trials network group, said he noticed that Sars-CoV-2 (Covid-19) shares 79% of their genetic material with the coronavirus responsible for Sars, and 50% with the coronavirus responsible for Mers.
“The modern biotech company made great progress on the covid-19 vaccine because they had worked long before on the Mers vaccine. An accelerated approach using the platform developed for Mers vaccines was used. Moderna’s Covid-19 vaccine is already in human testing phase I as of last week, “said Mehendale, who argued that developing the vaccine has always been a difficult and arduous task, generally requiring 10 to 15 years.
The covid-19 vaccine also appears to be following the path of the Ebola vaccine, the pandemic caused by the Ebola virus first identified in 1976 with a 50% death rate. The Ebola vaccine was developed during the Ebola epidemic in West Africa in 2014-2016, during which more than 11,000 people died. The vaccine was used under an “expanded access” protocol within a year of development in the Democratic Republic of the Congo before regulatory approvals. On November 12, 2019, the WHO prequalified an Ebola vaccine. This is the fastest vaccine prequalification process ever conducted by WHO reviewing safety and efficacy data as information became available and participated in the European Regulators Assessment (EMA) process.
“During Ebola, we approved the use of vaccines even in human trials to be used in patients due to the high mortality rate,” said Thacker. A senior DGCI official said that considering the damage caused by covid-19, including phase 1 vaccines, showing some efficacy may be approved in India or in any other country such as the Ebola vaccine.
In the case of tuberculosis (TB), the world’s deadliest infectious disease, with 1.6 million deaths and 10 million new cases in 2017, it was recently observed that a vaccine has been in development for more than two decades It shows promising results, but it may take another decade to become commercially available. The development and licensing of the first dengue vaccine spanned more than 20 years, although a safe universal vaccine is still expected.
“Despite the ongoing work on vaccines against malaria, tuberculosis and leprosy, we have still not been successful. In pandemic scenarios, the traditional 10-year vaccine development path could drastically shorten the time scale in case of newer vaccine development, “said Mehendale.
Although a vaccine for covid-19 may be available within a year, the scientists cautioned that safety and efficacy issues should not be ignored due to the continued mutation of the virus. “Even after the vaccine is available, data will need to be generated on whether the vaccine is effective in all populations and whether it is effective against different strains of the new coronavirus, which could begin to mutate over time,” Mehendale said.
“It is important to remember that having a vaccine that is known to work is not the same as having billions of doses of vaccine that can be instantly administered to everyone: we must think about manufacturing capacity along with vaccine testing,” Kang said.
