With the news on the novel coronavirus pandemic ever-changing, and the search for COVID-19 therapeutics still continuing, it is difficult to stay on top of the goings-on of the therapeutics in development. To help you stay on top of things, Nidhi Parekh of The Shared Microscope writes weekly updates on the therapeutics alone.
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There are currently 8 COVID-19 vaccines in the final phase of clinical trials.
What is the Oxford/AstraZeneca Vaccine?
Among the top COVID-19 vaccine contenders, is the Oxford/AstraZeneca vaccine. The vaccine uses a replication-defective viral vector type vaccine – for a jargon free article explaining these terms, check out our post here.
Oxford/AstraZeneca Vaccine Timeline
This vaccine has been in clinical trials in the UK since April 2020. It is now in late-stage clinical trials in the UK, and has been, since May 2020. In June 2020, the Oxford group was able to secure permissions to trial their vaccine in Brazil and South Africa. The results from these clinical trials looked promising. Following this, clinical trials begun in the United States in August 2020.
Despite the promise the vaccine was showing, the clinical trials had to be put on hold earlier this week. This was after a participant in the UK had a suspected adverse reaction. To read more on the hold, check out this post by Stat. Just today, the vaccine study has been resumed.
To learn more about how the vaccine works, how it trains our immune system, how it’s made, the evidence behind how the vaccine works, etc. check out our post here.
Counting down the days until there is a COVID-19 vaccine and the novel coronavirus pandemic is over? Nidhi Parekh of The Shared Microscope and Sheeva Azma of Fancy Comma, LLC are here to discuss a front-runner in the race to develop a vaccine for COVID-19. In this post, we talk about the Moderna mRNA vaccine — and help you learn more about how it works and why it is so promising.
What is the Moderna Vaccine?
The Moderna vaccine is an mRNA type vaccine – it contains all the necessary information on how to produce the SARS-CoV-2 spike protein. For more on how this vaccine works, feel free to check out our blog post here.
As of July 2020, the vaccine being developed by Moderna has entered Phase III Clinical Trials in the United States. In addition to this, interim Phase I results for the vaccine were published in the New England Journal of Medicine in July. The results indicated that the vaccine induced anti-SARS-CoV-2 responses in all participants. No adverse events were identified so far.
3. Sinovac’s CoronaVac Vaccine
What is the CoronaVac Vaccine?
CoronaVac is a vaccine of the inactivated type, being developed by Sinovac. This means that the SARS-CoV-2 vaccine is harvested in bulk, and then killed/inactivated so it can no longer cause any disease. The inactivated version of the virus is then injected into our body to raise a robust immune response. For more on this vaccine and how it works, check out our blog post here.
As per the preliminary Phase II Clinical Trial results from August 10, 2020, CoronaVac was well tolerated in participants aged 18-59 years and revealed no dose-related concerns.
Sinovac also received permission to start Phase III clinical trials in Brazil in the month of July 2020. Results from these clinical trials are still awaited.
4. Cansino’s Ad5-nCoV
What is Cansino’s Ad5-nCoV vaccine?
Cansino’s vaccine, like the Oxford University/AstraZeneca vaccine, uses a replication-defective adenovirus viral vector.
Phase I results from May 2020, published in The Lancet indicated that the vaccine was tolerable and immunogenic in humans. Following the publication, Phase I/II trials started in May 2020 in Canada. This vaccine received a lot of attention in June 2020, when it received approval for military use in China.
5. Unnamed Inactive Vaccine – Wuhan
What is the inactive vaccine from Wuhan?
The Wuhan Institute of Biological Products developed an inactivated vaccine, created by first harvesting the viral particles and then inactivating them using heat or chemicals. For this reason, the vaccine is similar to the CoronaVac vaccine listed above.
Phase I/II trials of this vaccine showed a production of antibodies in volunteers injected with it. Participants in this study showed a low rate of adverse reactions like fever. Phase III trials were later launched in United Arab Emirates in July. These were followed by clinical trials in Peru and Morocco. Results of these trials are currently awaited.
6. Sinopharm’s BBIBP-CorV
What is Sinopharm’s BBIBP-CorV?
Sinopharm’s BBIBP-CorV again, like Sinovac’s CoronaVac and Wuhan’s unnamed vaccine candidate, is a vaccine of the inactivated type. Upon vaccination, our body is able to generate a diverse immune response against the virus, to protect against future infection by the SARS-CoV-2 virus.
According to a study published in Cell, vaccination with BBIBP-CorV generates high numbers of neutralising antibodies and is safe and effective in animal models. According to the company’s press release, similar results were demonstrated in Phase I/II trials. Phase III trials are underway, and results are awaited.
7. BioNTech and Pfizer’s BNT162
What is BioNtech and Pfizer’s BNT162 Vaccine?
Like the Moderna vaccine, BioNTech and Pfizer have collaborated with Chinese drug maker Fosun Pharma to develop another mRNA vaccine. The messenger RNA in this vaccine is slightly different to the mRNA used in the Moderna vaccine. The BNT162 uses three different mRNA molecules that together code for various parts of the spike protein. Once vaccinated, host cells take up the mRNA, generate the spike proteins, and then present them to the immune system. The immune system recognises these spikes as foreign and generates an immune response against the spike protein.
In early July, the Phase I/II clinical trials of this vaccine demonstrated that they were safe and tolerable in the doses used in vaccination. In addition to this, the vaccine also elicits a robust immune response.
In response to these promising results, the US have ordered up to 600 million doses of this vaccine, with the first 100 million promised before the end of the year. The companies have since received approval to trial their vaccine among 30,000 patients for their Phase II/III clinical trials, in a total of ~120 sites globally.
8. The Russian Gam-COVID-Vac
What is the Gam-COVID-Vac?
The Gam-COVID-Vac, or the Sputnik V, is a COVID-19 vaccine candidate developed by the Gamaleya Research Institute (Russia).
On August 11, 2020, President Putin announced that Russia had approved a COVID-19 vaccine called the Gam-COVID-Vac. The vaccine was approved prematurely, having only been tested on 38 people in Phase I/II trials. The vaccine has since entered Phase III trials with an enrolment of 40,000 participants in Russia.
Below are the main updates from the World Health Organisation on COVID-19 media briefing dated September 10, 2020.
According to Dr. Tedros, we have made remarkable progress in accelerating the development of vaccines, diagnostics and therapeutics against the novel coronavirus pandemic. In his opening remarks, Dr. Tedros spoke highly of dexamethasone, which has proven effective for patients with severe COVID-19 infection.
To date, 180 vaccines are currently in development, of which 35 are in human trials. 8 of these vaccines are in phase III clinical trials and updates on these have been briefly given above.
Dr. Tedros also took the opportunity to remind us that although the current ambition is to develop vaccines and drugs against the SARS-CoV-2 virus (which causes COVID-19), it is equally important to make these vaccines accessible worldwide.
WHO Question Time
One of the most important questions asked during the press briefing was about the halt in the Oxford/AstraZeneca vaccine. Although the study has now been resumed, we were reminded of the two key aspects of a successful vaccine: safety and efficacy. Every clinical trial has a standard operating procedure to manage any possible side effects. Reported adverse effects are reported and then fully studied – a decision will then be made.
When asked which COVID-19 vaccine was the most promising – we were reminded by Dr. Souma Swaminathan that there is no way of predicting this. We need the information from ongoing clinical trials to be able to answer this question. Dr. Swaminathan also reminded us that the date Phase I/II study data have been promising for most candidates that have passed Phase II; showing strong immune responses.
Dr. Michael Ryan also reminded us that developing a vaccine is not a race between companies and countries; it is a race to support public health in the safest way possible. It is not a competition between vaccine developers. Race against time, race against the virus, a race to save lives. Let’s not bet on any horses until we get to the end of this race.
“Developing a vaccine is not a race between companies and countries… It is a race against time, a race against the virus, a race to save lives. Let’s not bet on any horses until we get to the end of this race.” @DrMikeRyanTweet
Questions were also asked about why the numbers in COVID-19 deaths in Europe remain relatively low even as cases are rising? Has something changed about the virus? Is there a change in how Europe is controlling the vaccine?
Dr. Maria van Kerkhove responds to this question by highlighting a combination of factors. We were reminded that we are now eight months into a pandemic and scientists have been working round the clock to understand the virus and the infection better. We know more about how to identify cases earlier, how to provide clinical care depending on severity. We also know that early intervention is key: providing oxygen when necessary, symptomatic care, respiratory support, prescribing dexamethasone in severe cares.
We are also now in a better position to prevent the virus from infecting vulnerable populations: preventing the virus from entering facilities with vulnerable populations, preventing amplification events within vulnerable populations, etc. As society opens, we are seeing a resurgence especially in places where people congregate – night clubs, social events, etc.
Dr. Kerkhove concluded with another reminder that we need to be careful. We still don’t know the long term effects of this virus… We are learning about individuals who have long term effects and we need to focus on saving as many lives as possible, but also focus on preventing infections wherever possible.
“We still don’t know the effects of this virus… We are now learning about long term effects… We need to focus on saving as many lives as possible, but also focus on preventing infections wherever possible.” @mvankerkhoveTweet
Looking Back Over 6 Months
It has now been 6 months since we’ve been speaking of COVID-19 as a pandemic. The World Health Organisation declared COVID-19 as a Public Health Emergency of International Concern on January 30, 2020. Six months ago, on 11 March 2020, the World Health Organisation took one stop further and declared the multi-country epidemic a pandemic.
Since December 31, 2019, the World Health Organisation has been working on the pandemic round the clock across all regions worldwide. Scientists and policy makers have been applying knowledge that they have and don’t have to dictate policy to reduce the impact of the virus in terms of number of cases and deaths, and the impact of livelihoods.
As Dr. Ryan said, “We mourn the loss of people who have been lost. We celebrate the bravery of our front line workers. We stand with all the people around the world who have struggled to get by in this pandemic, we stand with those people who are feeling the pain from this pandemic and from many other reasons. We commit to continue the fight to suppress transmission of this virus and develop a safe and effective vaccine and deliver that vaccine to those who need it around the world. The end will not come soon. We are all tired, every citizen on the planet, is tired. We wish this virus was not here with us. But we must work to the end of this and I believe we will… We will continue the fight…”
The end will not come soon. We are all tired, every citizen on the planet, is tired. We wish this virus was not here with us. But we must work to the end of this and I believe we will.. We will continue the fight… @DrMikeRyanTweet
Dr. Tedros’ Biggest Worry
When Dr. Tedros was asked what about the current situation worries him the most, Dr. Tedros responded saying it was the lack of solidarity between people. “When solidarity lacks, and when we’re divided, that is a very good opportunity for the virus. It allows for the spread of the virus… Lack of solidarity remains to be the major challenge.”
“Lack of solidarity during the pandemic worries me the most. When solidarity lacks, and when we’re divided, that is a very good opportunity for the virus. It allows for the spread of the virus…” @DrTedrosTweet
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