COVID-19 Vaccine Tracker: Here's a status update on leading coronavirus vaccines that are ahead of the pack
COVID-19 Vaccine Tracker: Pfizer's first interim data, which suggested the vaccine is 90 percent effective, has raised the hopes of possible Covid-19 vaccine before the end of this year or early next year.
It is arguably the most awaited and widely tracked breakthrough in medicine in recent times. With over 52.7 million confirmed cases of Covid-19 worldwide as on November 13, a safe and effective vaccine is considered the quickest fix to end the pandemic.
Pfizer's first interim data, which suggests its vaccine is 90 percent effective, has raised hopes of a possible Covid-19 vaccine before the end of this year, or early next year.
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
How many types of vaccines are there?
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
What does it take to develop a vaccine of this kind?
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Pfizer and German firm BioNTech have developed a Covid vaccine candidate based on genetic material or mRNA that instructs human cells to make SARS-CoV2 antigen, eliciting an immune response. Though they had a late start, the two companies have covered a lot of ground and could create history by having the first vaccine to get US approval. Pfizer initiated Phase-2/3 or clinical trials on July 27. The vaccine is being tested on 30,000 participants in the US and countries like Argentina, Brazil, and Germany.
Status update Pfizer's first interim analysis suggested its COVID-19 vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 infection in participants who had no prior history of SARS-CoV-2 infection.
The announcement of early positive results from a late-stage clinical trial puts Pfizer-BioNTech ahead of other vaccine makers. Pfizer said it plans to ask the US FDA for emergency authorisation of the two-dose vaccine later this month, after it has collected the recommended two-month safety data.
There is a strong possibility of the vaccine being available in the US by the end of 2020. Based on current projections, Pfizer said it expects to globally produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
India availability Pfizer hasn’t yet announced its plans to make this vaccine available in India. It said it is talking to the government of India to include the vaccine as part of its COVID-19 vaccination efforts. The vaccine also requires specialised cold storage; it has to be stored at -94 degrees Fahrenheit, which could be a potential bottleneck in India for mass rollout, pushing up the cost of the vaccine. The high cost may become a deterrent to mass distribution in India, but could possibly be available in the private label market for those who can afford it.
Moderna's Covid vaccine is based on a similar mRNA platform as that of Pfizer-BioNTech. Pfizer's positive data has validated the mRNA platform, boosting Moderna's chances of a successful vaccine. The biotech firm, which is yet to launch a product, however had a clear head start over rivals, and raised hundreds of millions of dollars from the US government in funding. The company initiated phase-3, or late-stage, clinical trials on July 27. In Phase-3, the vaccine is being tested on 30,000 participants.
Status update Moderna is expected to release crucial data in coming days from a phase-3 trial that will tell us whether its coronavirus vaccine is effective. Moderna’s first interim analysis will come after 53 trial subjects become infected. The company plans to seek emergency authorisation for high-risk groups if the vaccine proves effective. The approval is expected in the first half of CY2021, but the possibility of an early approval can’t be ruled out.
India availability India availability is not known. This vaccine, too, requires sophisticated cold chain infrastructure, and could be expensive.
AstraZeneca-University of Oxford: AZD1222British-Swedish pharma major AstraZeneca and the University of Oxford are developing a Covid-19 vaccine based on a chimpanzee adenovirus called ChAdOx1 as a vector that has been modified to carry coronavirus genes and deliver them into human cells. The vaccine had a headstart, with phase-1 initiated in April.
Status update AstraZeneca said its first interim analysis will come after 75 coronavirus trial subjects become infected. This will give a fair idea of the effectiveness of the vaccine. The results are expected by the end of December. The approval is expected in the first half of 2021. AstraZeneca's partner Serum announced that it completed the dosing of participants in Phase-3.
India availability The vaccine would be distributed through Serum Institute of India. Media reports say that Serum has produced 4 crore doses - that's enough to vaccine at least 2 crore people in two doses. Serum has offered the vaccine at $3 per dose. The vaccine is expected to be available early next year.
Johnson & Johnson: JNJ-78436735
Johnson & Johnson developed a Covid-19 experimental vaccine based on adenovirus vector Ad26. The company has used the same viral platform to develop vaccines for Ebola and other viruses such as Zika, RSV and HIV.
What sets it apart is that it is a one-dose vaccine compared to two for other vaccine candidates and doesn’t need to be frozen for distribution, which will make transportation easy and save costs. Johnson & Johnson just took just three months to move from phase 1/2 to a late-stage trial. The company plans to enrol up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. If proven to be safe and effective, the first batch of the vaccine should be available for emergency use in early 2021.
Status update On Oct. 12, Johnson & Johnson announced it has put its trial on pause to investigate an adverse reaction in a volunteer. The trial resumed after eleven days. Despite the delay, the company expects to get results by the end of the year.
India availability The vaccine would be distributed through J&J partner Biological E. If successful, it is expected to be available in the first half of 2021.
Novavax vaccine is a protein sub-unit vaccine that uses part of the virus and combines with adjuvant, or booster, to deliver it as a vaccine. Novavax has spent three decades and burnt $1.5 billion trying to develop vaccines based on its recombinant nanoparticle technology and Matrix adjuvant platform without much success. It’s hoping Covid-19 will turn the tide. Novavax initiated phase-3 trial on September 24 in the UK. The trial is being conducted in partnership with the UK government’s Vaccines Taskforce, and is expected to enroll up to 15,000 individuals between 18-84 years of age over the next four to six weeks. The company is also launching a phase-3 trial of the vaccine in the US. The vaccine doesn’t need to be frozen for distribution, making it much easier to handle.
Status update The company expects to roll out the vaccine by mid-2021. In September, Novavax reached an agreement with the Serum Institute of India to produce as many as 2 billion doses a year.
India availability The vaccine would be manufactured and distributed by its partner Serum Institute of India, with which Novavax has an agreement to produce around 2 billion doses a year. The vaccine has to be given in two doses.
Sputnik V vaccine
Sputnik V, the Covid-19 vaccine developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the sovereign Russian Direct Investment Fund, became the first vaccine to be cleared for public use even before being tested for safety and efficacy. The vaccine is based on a modified human adenovirus as vector, which carries the protein of the SARS-CoV-2 virus. On September 16, RDIF reached an agreement with Dr Reddy’s to conduct clinical trials and distribute 100 million doses of the vaccine in India. The results of Sputnik V of Phase 1/2 clinical trials on 76 people were published in The Lancet early September, showing that the vaccine candidate triggered a strong immune response. Russia is enrolling 40,000 volunteers as part of phase-3. Along with India, the trials were underway in Belarus, the United Arab Emirates and Venezuela.
On November 11, the Russian Direct Investment Fund said that the evidence from their Phase 3 trial interim review indicated that the vaccine is effective. Based on 20 cases of Covid-19 among the trial participants, Russian scientists estimated that the vaccine has 92 percent efficacy. In India, Dr Reddy's will be soon initiating clinical trials of the vaccine on 1,500 people in phase-2 and phase-3. Dr Reddy's expects the data to be ready by March. The vaccine has to be given in two doses.
The vaccine would be distributed through Dr Reddy’s.
Bharat Biotech: Covaxin
Bharat Biotech is developing a Covid vaccine in collaboration with the Indian Council of Medical Research (ICMR). ICMR’s National Institute of Virology (NIV) had transferred the SARS-CoV-2 virus strain. Bharat Biotech has developed an inactivated vaccine based on the strain. The vaccine has been found to have elicited immune response in monkeys. Bharat Biotech initiated Phase–1 and 2 trials in July. The company has launched Phase-3 trials of Covaxin, where it will test the vaccine on about 25,000 volunteers in India.
Status update The vaccine is expected in the first half of 2021. Bharat Biotech has capacity to manufacture 100-200 million doses at two of its Biosafety Level (BSL) -3 facilities in Hyderabad. It is trying to rope in partners who can increase the capacity to 1 billion doses per annum. The vaccine has to be given in two doses.
The vaccine will be distributed by Bharat Biotech
Zydus Cadila: ZyCoV-D
Zydus Cadila has taken a novel approach to its potential Covid-19 vaccine. Called plasmid DNA, the vaccine consists of genetic material of SARS-CoV-2 proteins that instructs human cells to make SARS-CoV2 antigen, eliciting an immune response. The company says that this approach is easily replicable and scalable, requiring just Biosafety Level (BSL)-1. Zydus Cadila initiated Phase–1 and 2 trials in July.
Status update Zydus completed its Phase-1 and 2 trials, and will be submitting data in November. The company plans to test the ZyCoV-D vaccine on about 15,000-20,000 people in Phase-3 in December. The company expects to have final data by March-April 2021. The launch of the vaccine is expected in the first half of 2021.
ZyCoV-D vaccine can be stored at 2-8 degrees temperature, making it a good fit for the existing cold chain infrastructure. The vaccine is delivered through the intradermal (injected into the epidermis) route, which is much easier to administer compared to intramuscular injection, which requires training of healthcare workers.
Vaccine would be distributed by Zydus Cadila
Sanofi-GSK Covid vaccine lags behind but given that the vaccine comes from Sanofi, which has a huge manufacturing and distribution presence in India, its progress will be closely watched. The vaccine is based on a protein subunit, with adjuvant (booster) provided by GSK. The companies said the pre-clinical studies showed promise regarding safety and immunogenicity of the vaccine. On September 3, Sanofi and GSK announced the initiation of Phase 1/2 clinical trials.
Status update Both the companies aim to move into Phase 3 by the end of 2020. Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021. The vaccine is likely to be available in the second half of CY21.
India availability The vaccine could be available to India through Covax. Sanofi agreed to provide 200 million doses to COVAX, an international collaboration led by WHO, GAVI to deliver the vaccine equitably across the world.
The Chinese vaccine candidate based on human adenovirus Ad5 vector developed by CanSino Biologics and Beijing Institute of Biotechnology and Academy of Military Medical Science has become a major tool for China's vaccine diplomacy. The vaccine was approved by the Chinese military on June 25 for a year as a “specially needed drug”.
Status update Cansino vaccine entered phase-3 in August with plans to enrol 40,000 participants. China has got approvals in Russia, Pakistan, Saudi Arabia, for conducting phase-3 trials. Possible launch in second half of CY21.
Sinovac Biotech, the private Chinese biotech company, has developed an inactivated vaccine called CoronaVac, similar to the one developed by Bharat Biotech-ICMR. The company has found no severe adverse effects in its phase 1/2 trials, and found the vaccine to have immune response.
Status update Sinovac had launched a Phase 3 trial in Brazil in July, followed by others in Indonesia and Turkey. The trial was briefly paused early this week in Brazil, following an adverse event. The trial has now been resumed. The Chinese government gave the Sinovac vaccine an emergency approval for limited use in July, and the Jiaxing city authorities have started inoculating high-risk people with the vaccine.
India availability Not known.
Viswanath Pilla Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.