In recent weeks, three laboratories have published promising preliminary results on the effectiveness of their vaccine candidates in preventing COVID-19. According to their own studies from Oxford, Pfizer and Moderna, their drugs have more than 90% immunity to the coronavirus. However, these results still need to be submitted to a scientific review by a third party to be validated and, in addition, for the competent international organizations to approve the commercialization of the potential vaccines.
So far there are 12 laboratories whose candidates are in phase 3, that is, they are conducting massive efficacy testing; 17 are in phase 2, that is, they are doing extensive testing of the safety of the drug; and 38 are in phase 1, which is being used on a small number of volunteers to test safety and dosing.
To Antonio Pratto, a member of the Vaccine Command, they are “extraordinary news, bearing in mind that the FDA (North American government health agency) is asking for a vaccine to be 50% effective, what all these vaccines show is that they are way above what is required”.
According to Pratto, Pfizer and Oxford will apply to their respective health authorities for an authorization to use their medicines in emergencies, hoping to bring them to market before the end of the year.
“Chinese vaccines will also be ready in December, such as Sinovac, Sinopharm, Cansino – which has been on the Chinese market for a long time -, Gamaleya – which is from Russia. The same is likely to happen in the United States, the first quarter of the other year, with Moderna, Johnson & JohnsonSaid the specialist.
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AGREEMENTS WITH PERU
To date, the Peruvian state has signed a contract with Pfizer and the Covax Facility alliance for a total of 15 million doses, but this is not enough to keep the Peruvian population in check. The previous government, led by Prime Minister Walter Martos, had offers from Oxford, Sinopharm and Gamaleya, but no deal was reached.
“The idea was to vaccinate between 6 and 7 million Peruvians in the first quarter of 2021, before the elections, but so far nothing is concreteSaid the member of the Vaccine Command.
According to Pratto, this could be a lack of state decision as they wait for results, but when it does, there will be no vaccination for the first three months of 2021.
“We are in contact with Duke University and they are researching vaccine distribution worldwide. 9.5 billion vaccines have already been committed in various countries. AstraZeneca has signed with Argentina, Mexico, Ecuador, the Dominican Republic, El Salvador, Honduras and Costa Rica. Peru refused to sign because it felt that information was missing, despite the laboratory having the most dataHero.
For Pratto, it will not be possible to know which vaccine has better immunogenicity, that is, how long the antibodies remain in the body in three or four years. “Therefore, if the Department of Health is waiting for that kind of information, we will be at the end of the line right in the middle of this emergency., Considered the expert.
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TASTING IN PERU
Johnson & Johnson’s candidate vaccine is in Phase 3. They expect to recruit a total of 60,000 volunteers around the world, 3,000 of which will be Peruvian.
“Our COVID-19 vaccine program uses AdVac technology, the same technology we used to develop the Ebola vaccine – which has already been approved by the European Commission – and to build our candidates for other vaccines such as HIV, respiratory syncytial virus“, Detailed to Peru 21 the medical director of Janssen Latin America, Carlos Alvarado.
As explained by the expert, their vaccine is a vector vaccine, that is, they use an adenovirus – the cold virus – that is embedded with a coronavirus spike protein. This generates the organism’s immune response the moment the immune system recognizes the vector.
“Our technology has been extensively tested in other types of vaccines with nearly 110,000 people and so far we have not found any safety warningsSaid Alvarado.
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This laboratory will conduct its tests in Lima, Callao and Loreto. 50% of the volunteers will receive the vector and the other 50% the placebo.
Janssen’s medical director said they expect partial results from phase 3 in early 2021.This can be submitted to the regulatory authorities of any country; In the case of Peru, the National Institute of Health, Digemid will review this data and as considered within local regulations, they will be the ones to give the approval for the first use for the management of this emergency.Alvarado said.
Another laboratory conducting trials in Peru is Sinopharm, through the Universidad Peruana Cayetano Heredia, which recruits a total of 12,000 volunteers.
Consulted by Peru 21, the physician responsible for these tests, Germán Málaga, indicated that 3,000 people are missing to complete the second group of volunteers. Of those who have already received the two corresponding doses, none have had serious health complications.
“No major side effects have occurred. The expected things like muscle building site pain, headache, discomfort, diarrhea are over, but it doesn’t last more than two days”, Málaga explains.
Sinopharm plans to collect results from all countries where the trials have been conducted by two weeks in December and will be able to assess the percentage of efficacy of its vaccine candidate.
According to Malaga, for every 100 people who sign up for the trials, 30 will eventually receive the doses. Some don’t go to the first appointment, others are turned down because they already had the disease or because of a clinical condition.
We all hope that so many labs thrive to get out of this crisis that has left the whole world on edge.
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- Johnson & Johnson Laboratory enabled the page www.pe.ensemblestudy.com for citizens who want to volunteer in the trials being conducted in Peru.
- Laboratory registrations with Sinopharm also remain open. They have access to the internet www.vacunacovid.pe to be part of the volunteers.
- The AstraZenaca and Oxford candidate vaccine will also be tested in Peru. As announced by the lab, they will need about 3,000 volunteers.