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Globally, there are over 165 different COVID-19 vaccines in various phases of research. 30 vaccines are currently being tested in humans. Scientists are racing to produce a safe and effective vaccine as soon as possible. We review promising studies.
- Currently, there are over 165 clinical trials in various stages in the world with one goal: to develop and implement a vaccine against COVID-19. Some projects are already in the human testing phase
- Scientists work with the genetic material of the virus, using fragments of its proteins or the entire inactivated particle. They also work on the so-called vector viruses
- Some companies already declare that they are able to produce hundreds of millions of vaccination doses, which may be available as early as the end of 2020 and the beginning of 2021.
- Our Country has taken the lead in the race for the vaccine. On August 11, Vladimir Putin announced that the COVID-19 vaccine had been approved in the country
- Pfizer, which has announced that its vaccine is 95% safe and effective, is seeking provisional approval from the FDA for its use
- A vaccine developed by Moderna, which has almost 95 percent. effectiveness, unlike Pfizer, it can be stored in a refrigerator
- About 70 percent Oxford University also reported on the effectiveness of its vaccine
- You can find more up-to-date information on the TvoiLokony home page
Testing vaccines for COVID-19
Vaccinations are considered human achievements. Thanks to them, it was possible to eliminate or significantly reduce many diseases that have taken a deadly toll on people over the years. During the COVID-19 pandemic, scientists are doing their best to develop a vaccine against COVID-19. There are currently over 165 different studies going on around the world. Some companies have already entered the human research phase.
And while no effective vaccines against coronaviruses have been developed so far, this time may be different. Many governments have committed millions of dollars in grants to hundreds of scientists who are working on the vaccine. They also benefit from the fact that thanks to the achievements of modern science, they understand better and better the functioning of the immune system.
However, before the vaccine reaches the market and potential recipients, it must be tested. It usually takes several years to develop, test and approve a vaccine. However, speed matters here, which is why companies decide to combine different phases of clinical trials. In America, a special Warp Speed program has been set up to ensure that five or more of the most promising vaccine projects receive billions of dollars in federal research funding.
What happens during each phase of vaccine clinical trials?
This is the first clinical experience in which a new experimental vaccine is administered to humans. Phase I can last up to 24 months and usually involves 20 to 100 volunteers. This phase collects data on the safety of the vaccine, with particular attention to possible side effects. It can also provide knowledge about the dose and schedule of vaccine administration. Volunteers participating in this phase of clinical trials may differ in age from the target group. If the observations made in this phase show that the new vaccine is safe, well-tolerated and promising, phase II clinical trials can begin.
It can last more than two years and usually involves 100 to 300 volunteers. Information on the experimental vaccine safety and immunogenicity is gathered at this stage. Phase II can be sped up by the Intermediate Phase (IIb) studies which allow a preliminary assessment of the efficacy of a new vaccine by comparing the incidence among vaccinated and unvaccinated control volunteers.
The most promising vaccines are qualified for this phase. The study is designed in 10 or more volunteers and may last up to 000 years. Through these studies, enough data can be gathered on the safety and efficacy of the vaccine for approval by registration and regulatory authorities. In the United States, for ethical reasons, the principle of testing the effectiveness of vaccines in animal models has been introduced by law. (source: badaniaklinicznewpolsce.pl)
See:
- Usually, work on vaccines takes 10 years. Will the coronavirus one be created in two years?
- Virologist on the prospect of a COVID-19 vaccine and the work of Poles that can help in this
Genetic vaccines against COVID-19
Pharmaceutical companies are testing different variants of SARS-CoV-2 coronavirus vaccines. Genetic vaccines use one or more genes of the virus to elicit an immune response. Such a solution was tested, among others, by Moderna, which announced that its preparation is 94,5 percent effective. It contains a synthetic version of the genetic material of the coronavirus, called mRNA, which triggers an alarm in the immune system and, when exposed to a real coronavirus, triggers the immune system to attack and is given in two doses. As for the method of distribution, the Moderny vaccine should be stored in a freezer for a long time (at -20 degrees Celsius), while it can be stored in an ordinary refrigerator for a maximum of 30 days.
During the phase III studies, no significant safety concerns were reported.
Check: Pfizer and Moderna have COVID-19 vaccines. What do we know about them?
The vaccine of the German company BioNTech and the New York-based Pfizer works on similar principles, cooperating with the Chinese drug manufacturer Fosum Pharma. On July 1, companies announced that all volunteers who participated in the Phase I / II study had developed antibodies to SARS-CoV-2. Some of the test subjects experienced moderate side effects such as sleep disturbance and shoulder pain. Phase III clinical trials began in July. The vaccine was 94% effective. in elderly people who are more prone to severe COVID-19.
The companies want to apply to the US Food and Drug Administration for approval to introduce the vaccine to the market as soon as possible. Pfizer will deliver it in special boxes filled with dry ice and equipped with GPS sensors. The vaccine can be stored in conventional freezers for up to five days or in special refrigerators for up to 15 days, as long as the dry ice is refilled and the boxes are not opened more than twice a day. The company plans to produce 50 million doses by the end of the year.
Imperial College London is also working on a vaccine that uses virus RNA fragments. In mid-June, in cooperation with Morningside Ventures, they began phase I / II trials. Scientists expect to answer the question of whether the vaccine is effective by the end of the year.
California-based Arcturus Therapeutics, which cooperates with Duke-NUS Medical School in Singapore, also joined the race. Scientists from these institutions developed an mRNA vaccine. The ‘self-replication’ project of vaccine particles led to strong immune responses in animal experiments. On July 21, Singaporean authorities approved an application for a Phase I / II human trial.
Indian vaccine manufacturer Zydus Calida, Japanese biotechnology company AnGes in cooperation with Osaka University and Takara Bio, American company Inovio, German CureVac, Korean company Genexine, Academy of Military Medical Sciences in cooperation with Suzhou Abogen Biosciences and Walvax Biotechnology.
A genetic vaccine developed by the pharmaceutical company Sanofi in cooperation with Translate Bio is also in the preclinical research phase. On June 23, these companies announced that they plan to begin the first phase of clinical trials in the fall.
Vector vaccines against COVID-19
Vector vaccines use fragments of other viruses to trigger an immune response against a given virus – in this case, the SARS-CoV-2 coronavirus. The most promising research on this type of vaccine is carried out by AstraZeneca in cooperation with the University of Oxford. The vaccine is based on the chimpanzee adenovirus, ChAdOxl.
This vaccine is in Phase II / III trials in England and Phase III trials in Brazil and South Africa. The company declared that it could deliver emergency vaccines as early as October, and the company’s total production capacity oscillates around 2 billion doses. The results of the first stage of tests have been officially known since July 20 thanks to the publication that appeared in the Lancet magazine that day. The UK vaccine is boosting immunity against the coronavirus, and so far it appears to be safe.
On November 23, AstraZeneca and the University of Oxford said the vaccine they are working on has 70 percent. effectiveness. The advantage of the Oxford vaccine over others is that it is much cheaper, easier to store and distribute, compared to the Moderna and Pfizer vaccines.
For more information: There are studies with AstraZeneca. BBC: success and disappointment rolled into one
The Chinese company CanSino Biologics is also working on the vectored vaccine. The company developed the Ad5 adenovirus vaccine in collaboration with the Chinese Institute of Military Biology of the Academy of Medical Sciences. The first, promising test results for this vaccine appeared in May. In July, researchers reported that phase 9 trials showed that the vaccine elicited a strong immune response. The Chinese military approved the vaccine as a “special need medicine”. It has not been confirmed whether the vaccinations of soldiers will be compulsory or voluntary. On August XNUMX, the Saudi Ministry of Health announced that CanSino Biologics’ Phase III clinical trials will be conducted in Saudi Arabia. The company is also negotiating with other countries to increase the sample size.
Our Country has also joined the race for the vaccine. In June, the Gamaleya Research Institute, which is part of the Ministry of Health, began trials of the first phase of research. The vaccine called Gam-Covid-Vac is based on a combination of two appropriately modified adenoviruses Ad5 and Ad26. Phase III trials were scheduled for September, but they were accelerated and started at the beginning of August. On August 11, Vladimir Putin announced that the vaccine had been registered. Our Country plans to produce around 30 million vaccines for its own use and another 170 million for use in other countries.
Zobacz: Our Country registers COVID-19 vaccine. First vaccinations in October?
Vaccines based on vector viruses from companies such as Johnson & Johnson in cooperation with Beth Israel Deconess Medical Center, Novartis, Merck (which outside the United States and Canada operates under the name MSD) in cooperation with IAVI as well as Themis Bioscence and Vaxart are in the preclinical research phase .
Some companies are testing vaccines that use the coronavirus protein or a fragment of it to trigger an immune response. The Chinese company Anhiu Zhifei Longcom started in July a second phase trial of the vaccine, which is a combination of viral proteins and an adjuvant that stimulates the immune system. The company cooperates with the Chinese Academy of Medical Sciences to test the vaccine.
Novavax, a Maryland-based company, received large financial support from the US government. The company began testing a COVID-19 vaccine in May based on previous experience with developing the flu vaccine. On July 6, the company received $ 1,6 billion in clinical research and manufacturing support. Previously, the coalition for innovation invested 384 million in the vaccine. On August 4, the company announced promising results from two preliminary phases of research involving monkeys and humans. Novavax expects to deliver approximately 100 million doses of the vaccine to the United States by the end of the first quarter of 2021.
- The Americans will start producing the vaccine before the end of clinical trials
The vaccines prepared by Clover Biopramaceuticals in cooperation with the British drug manufacturer GSK and the American company Dynavax are also in the first phase of clinical trials. Thanks to the support of production development, companies will be able to produce hundreds of millions of doses per year.
Sanofi is also conducting preclinical studies to obtain a vaccine based on the viral protein. The same that is also developing an mRNA-based vaccine. Sanofi is collaborating on a protein vaccine with GSK. The company declares that it can produce at least 600 million doses per year if, of course, the vaccine proves its effectiveness in research.
Whole Virus COVID-19 Vaccines
Some companies are also researching vaccines that contain a weakened or inactivated version of the coronavirus that is expected to trigger an immune system response. Advanced work on this type of vaccine is carried out by the state-owned Chinese company Sinopharm. In July in the Arab Emirates, after the inactivated viral vaccine was found to be safe and induced an immune response, the third phase of clinical trials began. The first volunteer to test the vaccine was the Abu Dhabi Minister of Health. In total, tests on 15 volunteers were planned.
Phase III clinical trials are also conducted by the private Chinese company Sinovac Biotech. The company’s inactivated vaccine, CoronaVac, has already passed Phase I / II clinical trials. In June, the company announced that a study of 73 volunteers showed no serious side effects and, most importantly, triggered an autoimmune response. In July, the company began phase III trials in Brazil. If the research shows positive results and the vaccine is approved, Sonovac Biotech estimates that it will produce around 100 million doses per year.
It is also worth paying attention to the research of scientists from the Institute of Medical Biology of the Chinese Academy of Medical Sciences. In June, they started Phase II research on an inactivated viral vaccine. This institute invented vaccines against polio and hepatitis A.
The Indian company Bharat Biotech is also conducting its research in cooperation with the Indian Council of Medical Research and the National Institute of Virology. They are working on an inactivated rabies virus designed to carry coronavirus proteins. The start of the research phase I / II is scheduled for July. Interestingly, the Indian Council for Medical Research reportedly predicts the vaccine will be ready for public use as early as August 15, but there is no indication that the goal is realistic.
What do experts say about the progress of the COVID-19 vaccine development?
The results of the research on the COVID-19 vaccine that AstraZeneca is testing in collaboration with the University of Oxford have received wide coverage among experts. Chris Whitty, England’s chief physician, was skeptical about the vaccine-related hurrayoptimism. She admits that they are all very excited and proud of the UK leadership role in vaccine research. «But no one should deceive himself. The chances of getting a highly effective vaccine before Christmas are very small in my opinion, »added Whitty.
Professor Anthony Fauci is more optimistic about the research. The director of the National Institute of Allergy and Infectious Diseases admitted that specialists in China are conducting research on a vaccine to protect against coronavirus as advanced as in the United States. He said that this preparation could also be ready in 2020, slightly earlier than the American one. If that happened, he said, “it will not happen much sooner than with us.” “I’m sure of it,” he added.
According to Fauci, similarly advanced research is also carried out in other centers around the world. “I am not worried about who will be first” – he emphasized. In his opinion, the point is for the vaccine to be available in the world as soon as possible.
Fauci also points to one fundamental problem – it is not certain how long COVID-19 vaccines will provide immunity against SARS-CoV-2 coronavirus infection. A growing body of research suggests that levels of antibodies to COVID-19 remain in the body for a short time, which makes it much harder to develop an effective vaccine.
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