The urgency that the global pandemic caused by the new coronavirus gave to this historical partner time shook especially and forever the entire world scientific arc. And surely the most relevant fact – and fascinating at the same time – is the acceleration of time: the speed of science for producing findings to solve the problems of humanity. Without neglecting the rigor that scientific research requires. This is where the idea of the plague cure (from COVID-19) is lodged. And therefore there is also the hope of a society that wants to be full again.
The race for the vaccine is a great example of this: Research processes that required between 5 to 10 years for the production cycle of a vaccine, have been transformed into processes of just 5 months, to face a virus like SARS-VOC-2, about which aspects of their immunological behavior are still missing to unravel when it infects people. Today, there are at least 5 vaccines that are in a firm race to enter phase III and test it in volunteers and certain age groups, numerous, where the vaccine will be evaluated versus placebo.And in that phase, the long-awaited effectiveness can be verified.
What is the ultimate goal of an effective vaccine and at the same time becomes the obsession that flies over the work of scientists within the laboratory? protect human beings against a certain disease, producing antibodies; but without producing the disease. This delicate balance is what has to be achieved.
There, the results published yesterday in the scientific journal The Lancet which confirmed that the experimental vaccine Jenner Institute at Oxford University in association with the AstraZeneca laboratory against COVID-19 it is safe and generates immunity. These were phase I and II studies that evaluated safety, pending evaluation of efficacy and based on a recombinant adenovirus vector.
The results in The Lancet confirmed that a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus peak protein in 95% of participants one month after injection. In all participants, a T cell response was induced, which peaked on day 14, and was maintained two months after injection. These initial studies confirmed that the vaccine was capable of generating antibodies in humans and does not have severe adverse events.. According to scientific spokesmen for AstraZeneca and scientists from Oxford to Infobae: “Phase I / II data on 1,077 healthy adult volunteers ages 18 to 55 show that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type.”
Consulted by Infobae, the infectious medicine doctor Pedro Cahn, Argentine scientist and researcher in the fight against HIV-AIDS and fundamental reference of the expert table of President Alberto Fernández explained to Infobae his vision on the vaccination career against COVID-19, “we are in a very good moment of the fight against COVID-19, because there are several dance vaccination projects. In the same publication yesterday of the magazine The Lancet the vaccine of Oxford produced by that university together with the AstraZeneca laboratory, and also by the CanSinoBIO laboratory in China. Also in the running is the Modern Laboratory in the United States; and of Pfizer that will have volunteers and clinical studies in Argentina. There are 5 vaccines that are entering phase III and that is very good, of course we still do not know which one will work. But surely from the quantity of vaccines that we have, it is probable that a quality will emerge that will allow us to have one or two that are effective.“
“These vaccines have different platforms or mechanisms. There are vaccines that work with inactivated viruses, there are vaccines that work with mRNA, that is, with messenger ribonucleic acid; and there are others that work with an adenovirus vector, a cold virus (NdelaR: the latter is the platform that the Oxford vaccine used), “said Cahn.
What phase I and II of the Oxford-AstraZeneca vaccine then demonstrated is a neutralizing activity against the SARS-CoV-2 virus, in 91% of participants one month after vaccination; and in 100% of the participants, who received a second dose. The neutralizing antibody levels observed in participants who received one or two doses were in a similar range to those observed in convalescent patients with COVID-19.
Adverse effects included pain and tenderness at the temporary injection site, mild to moderate headache, fatigue, chills, fever, malaise, and muscle pain. No serious adverse events were reported with AZD1222, and reactions decreased with the use of prophylactic paracetamol, a pain reliever, and occurred less frequently after a second dose.
For Dr. Daniel Stecher, infectious medicine doctor and head of Infectology at the Hospital de Clínicas, The data being released from both the Oxford-AstraZeneca vaccine and similar ones is encouraging. It should be clarified that they correspond to the initial studies (Phase I and II) that confirm that they are capable of generating antibodies in humans and do not have severe adverse events. The next step is studies in large numbers of people (Phase III) in which one group of people receives the vaccine and the other a harmless substance (placebo). In this way it will be possible to see if the vaccine is really capable of preventing the disease. Regarding the number of doses needed, it will probably be different for each vaccine – depending on the technology each is mounted on. This is encouraging but not definitive data on the possibility of developing an effective and safe vaccine to control the pandemic, “Stecher told Infobae.
In dialogue with Infobae, the infectious medicine doctor Waldo Belloso, member of the Argentine Society of Infectology (SADI), “what he published The Lancet it is a Phase I and II study demonstrating that the vaccine generates antibodies, and that the vaccine is safe. Phase I and II studies are primarily to assess safety, not to assess efficacy. For this reason, the scientific groups report that progress is being made with the implementation of Phase III in different countries, and this is really what is needed to know if the vaccine will be effective or not. ”
Belloso said, “In parallel, there is a business decision by the laboratory to move forward with manufacturing, and to have stock to distribute it. That is an intelligent and very bold decision on the part of the laboratory because it involves taking the risk of launching the manufacture of a vaccine whose efficacy has not yet been proven, “Belloso said.
Pros and cons
-In the opinion of the experts involved in the AstraZeneca vaccine research process – Jenner Institute of the University of Oxford and the Oxford Vaccine Group, what are the pros and cons of the new vaccine in scientific terms? Infobae asked the Astrazeneca spokesmen.
– This vaccine uses a weakened version of a common cold virus (adenovirus), which causes chimpanzee infections and contains the genetic material of the SARS-CoV-2 spike protein. After vaccination, the immune system is prepared to neutralize the SARS-CoV-2 virus in the event of an infection. AZD1222, formerly known as ChAdOx1nCoV-19 it is the new vaccine.
After vaccination, the surface peak protein is produced, preparing the immune system to attack the SARS-CoV-2 virus if it then infects the body. The recombinant adenovirus (ChAdOx1) was chosen to generate a strong immune response, from a single dose and does not replicate, therefore it cannot cause an infection in the vaccinated individual.
COV001 is a phase I / II single-blind randomized controlled trial to determine the safety, immunogenicity, and efficacy of the vaccine candidate COVID-19 AZD1222 in up to 1,077 healthy adults, and at five trial sites in the United Kingdom. Participants aged 18-55 years received either a single dose or two doses of AZD1222 at 5×10 10 viral particles, or a single dose of a MenACWY meningococcal conjugate vaccine as a control vaccine.
-Once the scientific efficacy of the vaccine finding is verified. What will the company’s vision be on the scalability of the production of the vaccine to make it accessible to the greatest number of people? How is the scale production of this essential input for a population of 6 billion people resolved?
–AstraZeneca’s strategic focus has focused on partnering with scientists, governments, multilateral organizations and manufacturers to establish agreements for the development, supply and distribution of the vaccine if it is effective and well tolerated. We are working tirelessly towards the goal of supporting broad, timely and equitable access to the candidate vaccine at an unprecedented rate.
We have now announced partnerships with the UK, USA, Brazil, Japan, VAT, CEPI, and Gavi and IBS to supply more than 2 billion doses of the developing vaccine starting in the last quarter of 2020.
– How can you define for the general public what it means that a vaccine like this one – the one from Oxford / AstraZéneca – has reached a phase II / III with your clinical trial?
Phase II and III late-stage trials will determine how well the vaccine can protect people from COVID-19 disease, measure safety and immune responses in different age ranges, at various doses and with some groups that receive booster doses.
When will it be available? “LThe vaccine will take a while. TEveryone is working very hard to achieve the results and our hope is to be able to start distributing it before the end of the year.“, answered Pascal Soriot, executive director of the pharmaceutical company AstraZeneca.
Phase II / III late-stage trials are currently underway in the United Kingdom, Brazil, and South Africa, and should begin in the United States. They will determine how well the vaccine will protect against COVID-19 disease and will measure safety and immune responses at different age ranges and at various doses.
As for whether this vaccine should be administered once in a lifetime or year to year, as in the case of the flu, Pangalos assured that “the study will tell us how long the protection of the vaccine lasts, but it will probably be a year or little more, ”explained Mene Pangalos, executive vice president of Biopharmaceutical Research and Development at AstraZeneca.
Belloso infectologist added to Infobae: “There are two more aspects to point out about the Oxford-AstraZeneca vaccine: on the one hand, the scientific aspects that cannot be accelerated. And on the other, the implementation or logistical aspects that can be accelerated. The laboratory’s decision to move forward with production to ensure a certain level of stock and distribution is interesting and involves risk. It is a good decision and it was expected from science that some groups do so in this urgent time that the pandemic imposes. What cannot be accelerated are the times of scientific evaluation. There are many who believe that the first vaccines will not have the desired efficacy to vaccinate the entire population. We will have to wait for those results ”.
As you could know Infobae, late yesterday afternoon, the Minister of Health of the Nation, Ginés González García, held a meeting with representatives of the pharmaceutical company AstraZeneca to learn about the progress of the potential AZD1222 vaccine. “It is the will of Argentina to be part of clinical trials and that there is a transfer of technology, as well as guaranteeing rapid and equitable access to the potential vaccine,” said González García.
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