COVID-19 CORONAVIRUS PANDEMIC AND PRODUCTION OF VACCINE TO STOP IT!
COVID-19 CORONAVIRUS PANDEMIC AND PRODUCTION OF VACCINE TO STOP IT!
The coronavirus COVID-19 is affecting 218 countries and territories around the world.
Coronavirus Cases: 66,401,028
COVID-19 infection in India is showing no signs of slowing down, with the country almost reaching 10 million coronavirus cases.
In India– Coronavirus–Population
Coronavirus Cases: 9,609,574
Scientists worldwide are working faster than ever to find vaccines that could stop the spread of COVID-19. Now, nearly a year on from the start of the pandemic, the following are some promising vaccines on the brink of going through regulatory approval to be rolled out.
COVID-19 vaccines in India:
Indian pharmaceutical companies in the race to develop a vaccine for deadly Coronavirus.
At least seven Indian pharma companies are developing a vaccine against Coronavirus as they join global efforts to find a preventive to check the spread of the deadly virus that has already infected more than 14 million globally. They are:
1. Bharat Biotech:
Hyderabad-based Bharat Biotech has received approval to conduct phase I and II clinical trial for its vaccine candidate Covaxin, that has been developed and manufactured in the company’s facility in Hyderabad.
Last week, Bharat Biotech started human trials of its vaccine Covaxin at Rohtak’s Post-Graduate Institute of Medical Sciences.
2. Serum Institute:
The Pune-based leading vaccine major Serum Institute of India (SII) has said that it hopes to develop a COVID-19 vaccine by the year-end. The company is also developing a live attenuated vaccine with US-based biotech firm Codagenix, which is undergoing pre-clinical trials, he added.
3. Zydus Cadila:
Pharma major Zydus Cadila has said that it is looking to complete clinical trials of its COVID-19 vaccine candidate ZyCoV-D in seven months. The company had last week started clinical trials of its COVID-19 vaccine candidate with the first human dosing.
4. Panacea Biotec:
In June, Panacea Biotec said that it was setting up a joint venture firm in Ireland with US-based Refana Inc to develop a vaccine for COVID-19. In partnership with Refana, the company aims to manufacture over 500 million doses of COVID-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year, Panacea Biotec had said.
The Indian drug regulator has approved the phase I and II clinical trials of the vaccine for SARS-CoV-2 by Bharat Biotech after pre-clinical studies demonstrated safety and immune response. The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
5. Indian Immunologicals Limited (IIL):
The Hyderabad-based IIL joined hands with Griffith University, Australia by entering into an agreement for research collaboration to conduct exploratory research to develop a lead vaccine candidate for Coronavirus.
As part of the agreement, scientists from Indian Immunologicals and Griffith University will develop a ‘Live Attenuated SARS – CoV-2 vaccine’ or Covid-19 vaccine using the latest codon de-optimization technology.
Mynvax, the Indian Institute of Science, Bangalore incubated company, consisting of a team of eight scientists along with a team of three scientists from Prof Varadarajan’s Lab at IISc have been working on the vaccine since January. According to Mynvax Co-founder Dr Gautham Nadig vaccine being developed by Mynvax is unique than other candidates is that the vaccine can tolerate higher temperatures, which is extremely important as India already lacks sufficient cold chain facilities. Most of the other vaccine candidates need to be refrigerated at 2-8°C.
7. Biological E:
Hyderabad-based Biological E, which recently obtained the drug regulator’s nod to start phase I and II clinical trials of its Covid-19 vaccine candidate, hopes to enter into phase-III clinical trials by January-end and license the vaccine by summer.
Disclosing this in Hyderabad on Monday, managing director Mahima Datla said the company is currently evaluating four different formulations depending on different antigen strengths in the phase I-II combined studies.
Without having to wait to do a dose-finding study, Biological E, with preliminary immunogenicity data from 400 people by February, will enter into phase-III trials where about 30,000 people will participate. COVID-19 vaccines in Foreign countries:
Some foreign pharmaceutical companies who are in the race to develop a vaccine for deadly coronavirus are listed below:
1. Beijing Minhai Biotechnology (China)
Inactivated Vaccine- A phase 1 trial of this vaccine started on 2 October, with 180 healthy people aged over 18. The trial is being done in Jiangsu, China.
2. Cansino Biologics/Academy of Military Medical Sciences (China)
Viral Vector Vaccine- This phase 1 trial will evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different administration routes in healthy adults aged 18 years and older. The trial will include 168 healthy adults aged 18 years and older.
3. West China Hospital of Sichuan University (China)
Protein Subunit Vaccine- On 24 August, they got approval to run a phase 1 trial. The vaccine incorporates recombinant protein grown in insect cells. To make the vaccine, researchers encode the receptor-binding domain (RBD) in a gene, which they insert into a virus. They then infect insect cells with the virus, triggering them to make the molecule in huge amounts. The hospital’s State Key Laboratory of Biological Therapy developed the “insect vaccine”, which seems to stop an infection in monkeys without showing any apparent side effects.
4. Beijing Wantai Biological Pharmacy (China)
VIRAL VECTOR VACCINE- In 2019, researchers at the University of Hong Kong and Xiamen University created a nasal-spray vaccine for the flu based on a weakened form of the influenza virus. They have engineered the vaccine to produce part of the coronavirus spike protein, which has started phase 1 trials in partnership with Beijing Wantai Biological Pharmacy.
5. People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech (China)
RNA VACCINE- The vaccine is being tested with two age groups – one with people aged 18-59 years, and another with people 60 and older.
6. Immunitybio And Nantkwest (USA)
VIRAL VECTOR VACCINE-It is an adenovirus (Ad5) vaccine designed to deliver both spike protein and nucleocapsid DNA to drive both cellular and antibody immunity. The company plans to launch a phase 1 trial in California this month with people aged up to 55 years
7. Vaxart (USA)
VIRAL VECTOR VACCINE- Early in 2020, Vaxart began working on an oral vaccine for COVID-19 using an adenovirus called Ad5 to deliver part of the COVID-19 virus into the body to trigger an immune response. In October, they began phase 1 trials.
8. Covaxx (USA)
PROTEIN SUBUNIT VACCINE- COVAXX, a United Biomedical subsidiary, registered a phase 1 trial on 11 September in Taiwan and planned to run their phase 2/3 trial in Brazil.
9. Merck/Dohme/Lavi (USA)
Viral Vector Vaccine- Merck has joined forces with non-profit organisation IAVI to produce a vaccine candidate that will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO. The Ebola vaccine worked as well in the elderly as it did in young, healthy adults.
10. Merck/Institute Pasteur (USA)
Viral Vector Vaccine- Merck acquired the Austrian firm Themis Bioscience in June and is working on a vaccine initially developed at the Institut Pasteur. The vaccine uses the weakened measles virus to carry genetic material into cells. A phase 1 trial launched in August.
11. Reithera (Italy)
Viral Vector Vaccine-
The Italian biotechnology company ReiThera has developed a COVID-19 vaccine, called GRAd-COV2, based on an adenovirus that infects gorillas. In collaboration with the Lazzaro Spallanzani National Institute for Infectious Diseases, they launched a phase 1 trial at the end of July.
12. Ludwig-Maximilians University Of Munich (Germany)
Viral Vector Vaccine- On 30 September, phase 1 testing for this non-replicating viral vector vaccine was approved. The trial will include 30 healthy participants aged between 18 and 55 years.
13. Clover Biopharmaceuticals Inc., Gsk & Dynavax (Australia)
Protein Subunit Vaccine- The protein-based COVID-19 S-Trimer vaccine, which uses GSK’s adjuvant system, is now being tested in human clinical trials. This move comes after the promising results during the preclinical stage. The study will be conducted on 150 healthy adults in Australia. Clover has also obtained US$ 3.5 million from CEPI to prepare and launch phase 1 clinical trials in June. It is planning a phase 2 trial by the end of 2020.
14. Vaxine (Australia)
Protein Subunit Vaccine- Vaxine launched a phase 1 trial in July. Its vaccine combines viral proteins with an adjuvant that stimulates immune cells. Phase 2 trials are expected to start by the end of the year.
15. University Of Queensland & Csl Limited (Australia)
Protein Subunit Vaccine- Researchers at the University of Queensland, in Brisbane, are using a patented vaccine-development technique called a ‘molecular clamp’. They launched phase 1 trials in July. In September, the vaccine makers made an agreement with the Australian government to deliver 51 million doses if the vaccine works. They expect their first supply of the vaccines to be ready by mid-2021.
16. Medigen (Taiwan)
Protein Subunit Vaccine- Taiwan-based vaccine maker Medigen is making a vaccine made of a combination of spike proteins and an adjuvant from Dynavax. Their phase 1 trial started this month.
17. Finlay Vaccine Institute (Cuba)
Protein Subunit Vaccine- On 18 August, Cuba announced that the Finlay Vaccine Institute in Havana would start a clinical trial on a vaccine for COVID-19. The vaccine, called Soberana 1, contains a part of the spike protein, called RBD, along with an adjuvant to boost the immune response. The vaccine will be given in two injections during the trials that will involve 676 people aged between 19 and 80 years and finish in January 2021.
18. Vector Institute (Russia)
Protein Subunit Vaccine- On 26 August, a Russian biological research center known as the Vector Institute registered a phase 1/2 trial for a coronavirus vaccine called EpiVacCorona. On 14 October, Vladimir Putin announced that Russia had granted regulatory approval for this vaccine, even though phase 3 trials have not yet begun. This is the second COVID-19 vaccine the country has approved so far.
19. University Hospital Tubingen (Germany)
Protein Subunit Vaccine- Earlier this year, researchers at the University of Tubingen in Germany created a vaccine made of viral proteins, along with an immune-stimulating adjuvant. In September, they launched a phase 1 trial.
20. Imperial College (UK)
Rna Vaccine- This vaccine candidate uses self-amplifying RNA technology (saRNA) developed by researchers at Imperial College, in London. The clinical trial in the current phase will involve the administration of the two-dose vaccine to 300 healthy individuals. Volunteers have already started receiving the first dose of the vaccine. It began phase 1/2 trials on 15 June and has partnered with Morningside Ventures to manufacture and distribute the vaccine.
21. Medicago (Canada)
Virus-Like-Particle Vaccine- Partly funded by the cigarette manufacturer Philip Morris, Medicago uses tobacco species to make vaccines. Virus genes are delivered into leaves, and then plant cells create proteins that mimic those found on viruses. In July, Medicago launched phase 1 trials on a plant-based COVID-19 vaccine in combination with adjuvants from GSK and Dynavax. If this phase is successful, it plans to start phase 2/3 trials in October.
The impact of COVID-19 vaccines on the pandemic:
The impact of COVID-19 vaccines on the pandemic will depend on several factors. These include factors such as the vaccines’ effectiveness, how quickly they are approved, manufactured, and delivered, and how many people get vaccinated.
Most scientists anticipate that, like most other vaccines, COVID-19 vaccines will not be 100% effective. WHO is working to help ensure that any approved vaccines are as effective as possible, so they can have the most significant impact on the pandemic?
How safe are COVID-19 vaccines?
There are many strict protections in place to help ensure that COVID-19 vaccines will be safe. Like all vaccines, COVID-19 vaccines should go through a rigorous, multi-stage testing process, including large (phase III) trials that involve tens of thousands of people. These trials, which include people at high risk for COVID-19, are specifically designed to identify any common side effects or other safety concerns.
Suppose a clinical trial shows that a COVID-19 vaccine is safe and effective. In that case, a series of independent reviews of the efficacy and safety evidence is required, including regulatory review and approval in the country where the vaccine is manufactured, before WHO considers a vaccine product for prequalification. Part of this process also involves a review of all the safety evidence by the Global Advisory Committee on Vaccine Safety.
An external panel of experts convened by WHO will analyse the results from clinical trials and, along with evidence on the disease, age groups affected, risk factors for disease, and other information, will recommend whether and how the vaccines should be used. Officials in individual countries will decide whether to approve the vaccines for national use and develop policies for how to use the vaccines in their country based on the WHO recommendations.
After a COVID-19 vaccine is introduced, WHO will support work with vaccine manufacturers, health officials in each country, and other partner to monitor for any safety concerns on an ongoing basis.
Will COVID-19 vaccines provide long-term protection?
It’s too early to know if COVID-19 vaccines will provide long-term protection. Additional research is needed to answer this question. However, it’s encouraging that available data suggest that most people who recover from COVID-19 develop an immune response that provides at least some protection against reinfection – although we’re still learning how strong this protection is and how long it lasts.
It’s also not yet clear how many doses of a COVID-19 vaccine will be needed. Most COVID-19 vaccines being tested now are using two dose regimens.
India’s vaccination programme against Covid-19:
Prime Minister Narendra Modi on Friday, December 4, 2020, said India’s vaccination programme against Covid-19 would begin as soon as a go-ahead from scientists is given, and asserted that healthcare workers involved in treating coronavirus patients, frontline workers and old people suffering from serious conditions would be inoculated on priority.
AIIMS Director hopeful of emergency use of Covid-19 vaccine by December-end
AIIMS Director Dr Randeep Guleria on Thursday expressed hope that by the end of this month or early next month, at least one of the five vaccines being locally-tested should get emergency use authorisation from the drug regulator to be administered to the public starting with priority groups.
Vaccination Programme of Foreign Countries Against Covid-19:
The first consignment of the Pfizer-BioNTech coronavirus vaccine has arrived in the UK, the BBC reported. The consignment has been taken to an undisclosed location and will now be distributed to hospital vaccination canters around the UK, the news agency said.