In this Content
- What are the stages in developing of a vaccine?
- Which vaccines are currently under a promising stage of development?
- 1. Moderna Vaccine
- 2. Pfizer-BNTECH Vaccine
- 3. Sinovac Biotech vaccine
- 4. Oxford-AstraZeneca vaccine
- 5. Sinopharm vaccine
- 6. Johnson and Johnson Vaccine
- 7. Bharat Biotech Covaxin
- 8. Imperial College London vaccine
- 9. Novavax Vaccine
- 10. CanSino Biologics
- Who Would Get Coronavirus Vaccine First?
The Coronavirus pandemic has made the scientific community work hard to find a vaccine for the dreaded disease. As of the latest reports, there are as many as many as 140 or more vaccines are in a pre-clinical stages, while around 18 are in the Phase 1 of the testing process.
As per the latest count, as many as 165 vaccines against the Coronavirus have been under different development stages. Close to 27 different vaccines are under human trials as of now. In practice, the vaccines need several years of consistent testing, but the scientists have been racing against time to produce a vaccine later this year or early next year.
What are the stages in developing of a vaccine?
Developing a vaccine for a pandemic or any other disease takes years of testing and trials. It needs to go through different stages before being made available for the general public.
Different stages in the development of a vaccine can include
Exploratory Phase
This can involve as many as 2 to 4 years. Which has been fast tracked in the case of the current pandemic. The scientists explore the different options for the natural and synthetic antigens to fight the disease. As of now, over 250 different therapies and 165+ vaccines are under exploration, including those in the latest stages of development.
Pre-clinical stage
This stage develops the vaccine and tests it on mice and rats, or even monkeys. Under the normal scenario, the pre-clinical stage requires one or two years. The stage is used to assess the cell response by extrapolating the response shown on the animals to humans. The safe dosage and methods of administration are also calculated at this stage.
Clinical Development
This is one of the critical stages in the vaccine development and involves testing on humans. This can be an area where a majority of vaccines may fail. The stage involves four sub stages viz phase 1, Phase 2,Phase 3, and Phase 4.
Phase 1
Phase 1 involves testing it on a limited number of humans. The number can be around 20 to 100. The subjects chosen should be healthy. It involves the immune response testing and the reactions that it can cause in humans. It would take around two months to complete.
Phase 2
This involves testing the vaccine on a huge human sample that can include several hundreds. The subjects are segregated in different age groups to ascertain the effect on the different age groups. The stage also lets the scientists determine the schedule of immunization and the method of delivering it. The stage also determines the safety of the vaccine. This can take a few months to a few years.
Phase 3
Thousands of the people are vaccinated at this stage. The number of people infected as against those placed on the vaccine is determined here. The side effects and antidotes for the same are also determined in this stage. This is ideally the last stage, after which the vaccine is released for public use.
Phase 4
Not all vaccines are placed in this stage. Most of the vaccines are cleared for public use after clearing the Phase 3. The manufacturer may decide to continue to phase 4 if they want to improve the efficacy further.
Approval Stage
This should be self explanatory. The stages in the previous phases and their outcomes are analysed to arrive at the vaccine’s approval. The approval will be faster if there are similar vaccines developed in the past. It may not be the case where Coronavirus is concerned.
Manufacturing Stage
This is where the mass manufacturing of the vaccine is undertaken. The manufacturers need to invest in equipment, personnel, and infrastructure to manufacture the vaccines. The manufacturing also needs to be undertaken under stringent quality control guidelines.
If any vaccine is found to have any negative effects on any individual, the manufacturing, or any other stages that we have described here, it will go back to the pre-clinical or laboratory stage once again.
Which vaccines are currently under a promising stage of development?
There are as many as 13 vaccines that have surged ahead in multiple stages of development and testing.
1. Moderna Vaccine
Developed by the National Institute of health in the US, the vaccine development has reached phase 3 of clinical tests. The project has been under the US Operation Warp Speed program and has been working on the RNA to produce the viral proteins.
The firm started the first testing on humans in March 2020 and was able to achieve a few positive results. The phase 3 studies have been launched on July 27. The final trial will have a sample size of 30000 volunteers. The firm is looking to release the vaccine for public use by early 2021.
As of October, the company declared that they have finished recruiting around 30000 participants for the study of which 7000 are of age older than 65. They would test for the efficiency of the vaccine and also investigate any adverse effects to determine whether it is just coincidence or a serious concern. If the tests meet the standards specified by FDA, Moderns will apply for emergency use by the end of 2020.
The company was awarded $1.5 billion by the US government for 100 million doses of vaccine in case the vaccine proves effective. Similar deals have been inked with Canada, Japan and Qatar.
2. Pfizer-BNTECH Vaccine
This is a joint collaboration between German pharmaceutical BionTech and Pfizer in New York. The collaboration also has a Chinese firm Fosun Pharma joining in. The vaccine will be based on mRNA, just like the one from Moderna. The firm posted the Phase 1 and Phase 2 results in the US and Germany in July. The volunteers were reported to have produced the antibodies against the SARS-CoV-2.
There were a few minor side effects, such as sleep disturbances and sore arms. They came up with the plan for the Phase 3 tests on July 27 with 30000 volunteers. The tests will also be held in Argentina, Brazil, and Germany. The company was looking to release the vaccine for public use by October 2020.
As of November 9, the company created a landmark stage in the development of the vaccine wherein the data shared by it indicated that their vaccine was 90 percent effective. In October, they received permission to test the vaccine for the children below the age of 12.
With around 94 cases of COVID 19 the trial showing the promising results, Pfizer may apply for an emergency use authorisation by the end of November. The outgoing Trump administration has awarded $ 1.9 billion contract to the firm to supply 100 million does to be delivered by December, and further 500 million doses in future on the need basis. Pfizer and BNTech expect manufacturing over 1.3 billion doses by the end of 2021.
3. Sinovac Biotech vaccine
The Beijing based firm has been using the inactivated virus strain for developing the vaccine. The company announced the phase 3 trials in June with 743 volunteers. There were no severe adverse effects observed. The phase 3 trials were launched in Brazil in July.
The company is setting up a facility to manufacture 100 doses per day. It has received a $15 million from private equity firms Advantech Capital and Vivo Capital. The company has been testing the vaccine on 10000 volunteers in China and 9000 in Brazil. It will soon commence testing it on 1900 volunteers in Indonesia as part of the phase 3 tests. The vaccine is likely to be available by early 2021.
The company started testing the vaccine for children in Septmeber2020. While they are yet to release the late trial data, the officials in Brazil suggested that they have been rated to be among the safest five in the Phase 3 tests.
The company has signed a deal with Indonesia for supplying around 40 million doses by March 2021. The company has been planning a worldwide release and distribution by early 2021.
However, November 9 came up with a bad news when Brazil government paused the trial due to an adverse event. The details haven’t been given out raising speculations about the pause being of political nature.
4. Oxford-AstraZeneca vaccine
The vaccine being developed by the company is based on viral vectors. The phase 1 and phase 2 trials were reported on July 20 and have been observed to have no side effects of any severe nature.
It was found to raise antibodies for Coronavirus and a host of other immune defences. The phase 2 and 3 trials are currently underway in England, while the phase 3 trials are being undertaken in Brazil and South Africa. Based on a chimpanzee adenovirus called ChAdOx1, the vaccine has already begun the mass production.
The firm claimed that their plant is capable of producing the vaccine in two billion doses of capacity. Oxford-AstraZeneca vaccinewere expected to be available by September or October 2020.
European Union in August has inked an agreement with the firm for delivering up to 400 million doses. The tests were halted in Sept because of complications in one of the volunteers. The tests began again globally within a week, but except in the US. There was a report a death of a volunteer in brazil, but the tests were not paused.
Un November, the company stated that they are expecting the results of the trial by the end of December.
5. Sinopharm vaccine
The vaccine is stated to be in the latest stages of development and is under development with the assistance from Wuhan Institute of Biological Products and Beijing Institute of Biological Products. There are two different vaccines under development with those two institutes and uses an inactivated virus for the immune response.
The phase 3 trials were launched in July in the United Arab Emirates. Over 15000 volunteers have been enrolled for the phase 3 testing. The pharma company is planning to make the vaccine available for the public use by the end of this year.
The company has been testing two experimental vaccines and is expecting the results quite soon. In Sept, the company received approval of the UAE government to test vaccine on healthcare workers.
6. Johnson and Johnson Vaccine
The popular pharma company has been developing the vaccine with its recombinant Ad26.COV2-S and has fast tracked the development. The firm is in talks with the National Institutes of Allergy and Infectious Diseases(NIAID) to develop the vaccine in a fast tracked manner.
It would be worthwhile to notice here that the pharma company had developed vaccines for Ebola and other viral diseases with its Ad26 formula. The phase 1 and 2 trails have commences in July, and the firm is looking to release the vaccine by 2021. It has plans to develop a billion doses in 2021.
Phase 3 trials were launched in September with 60000 participants. The federal government has agreed to award $ 1 billion for 100 million doses if the tests are successful. Even the European Union has reached an agreement for 200 million doses.
The tests were paused in October following the complications in one of the participants. However, the tests were restarted in ten days. In nay case, the company expects the positive results by the end of 2020.
7. Bharat Biotech Covaxin
This is one of the two Indian pharma companies that have been developing a vaccine for Coronavirus. The company has been working with the Indian Council of Medical Research and the National Institute of Virology in India and has developed a vaccine called Covaxin. The vaccine is based on an inactivated form of the virus.
The pharma is currently undertaking phase 2 and phase 3 screenings in India. There were reports that the vaccine will be made available for the public use by August 15. However, the pharma company made it clear that the vaccine will not be available before early 2021. The current tests are expected to take three months to complete.
Bharat Biotech has announced that they will be launching the phase 3 trials. The Covaxin tests were not cleared and found to be successful in Phase 1 and phase 2. On October 23, the company made an announcement that the phase 3 trials will commence soon. No further details are available as yet.
8. Imperial College London vaccine
The vaccine under development from the imperial college of London has been based on the mRNA. The trials have commenced with over 300 individuals being immunised with two doses. The phase 3 trial has been planned for October. The scientists partnered with the Morningside Ventures for developing the vaccine.
The phase 1 and 2 trials commenced in June. The third stage of testing is planned with 6000 volunteers and will be taken up in October. If the tests go successful, the scientists are expecting to launch the product in early 2021.
As of November, the company has not come up with any updates. The researchers at the institute believe that the vaccine will be effective by the end of the year.
9. Novavax Vaccine
The vaccine has been in the first stage of clinical trials as of now. The technique involves using proteins stuck to microscopic particles. The vaccine has been created for a number of diseases using this vaccine creation technique. The trials were launched in May and now have the human trials have been launched in Australia.
Once the first phase results are made available in July, the phase 2 trials will begin in several countries across the globe. The company has been planning to launch the product in late 2020, with 100 million does and supplement it up with 1.5 billion doses in 2021.
The company has launched phase 2 trials in South Africa in August. The Phase 3 trial in UK started in September with 15000 volunteers. By the end of November, the brand has been a larger phase 3 trial in the US.
In September, the company signed an agreement with the Serum Institute of India to produce 2 billion doses per year. In case the trials succeed, the company will deliver 100 million doses to United States by the first quarter in 2021. In November, they reached a similar agreement with Australian government to supply 40 million doses.
10. CanSino Biologics
The China based CanSino Biologics has been developing a Coronavirus vaccine and has been marked as one of the top contenders by WHO. The vaccine is being developed on an Adenovirus Type 5 Vector using a Non-Replicating Viral Vector platform. The company published promising results of the phase 1 trials in May.
The phase 2 trials were conducted in July and exhibited a strong immune response. The vaccine is being developed as a joint collaboration between CanSino Biologics and the Beijing Institute of Biotechnology. In a surprise move, the Chinese military approved the drug for military use.
Well, those were a few best or top contenders for the different stages of vaccine development for Coronavirus. Except for a couple of vaccine developers, almost all of them are expected to be available in early 2021.
Coming from China, the developer is not forthcoming with any major updates about the status of the development. The phase 3 trials were launched in September several countries that include Russia, Pakistan and Saudi Arabia.
Well, now that there are several vaccines under development, who will get the vaccine first? Ideally, it would be the persons who are the residents of the country where the virus is invented. There are several vaccines under development in different development stages, and people in those countries would be the first to benefit.
The development has been underway in multiple countries such as Britain, China, India, and the US. In fact, multiple wealthy countries have already ordered millions of doses of those vaccines which are still under development.
Well, that was all about the Coronavirus vaccine updates. In fact, we have picked only ten vaccine developments, and there are several other vaccine developments underway. Almost all vaccines are expected to be available in the market by the end of 2020 or in early 2021.