Filenews 20 November 2020
With the coronavirus pandemic galloping around the world scientists and pharmaceutical giants are working feverishly to develop vaccines that will light the green light for a gradual return to normality.
Dozens of vaccines are being developed and tested around the world and in recent times promising news has been announced for some of them, such as yesterday for that of AstraZeneca/Oxford University, the results of the second phase of clinical trials of which have shown that it produces a strong immune response in healthy elderly people. The following list includes those currently ahead of the race and when they may be on the market. Pfizer and Moda's vaccines are ahead, with Pfizer, in fact, currently filing an application for approval with the US FDA.
Pfizer - BioNTech
The vaccine from US pharmaceutical giant Pfizer and German biotech company BioNTech is in the third phase of clinical trials and has been found to be 95% effective in preventing volunteers from being infected with the deadly coronavirus. According to Pfizer, the efficacy of BNT162b2, as its vaccine is called, was the same in all age groups of regardless of race and national origin and no serious side effects were found. Efficacy reached more than 94% in people over the age of 65.
The final analysis was published one week after the announcement of interim results showing more than 90% effectiveness of the vaccine. Phase 3 of clinical trials of the vaccine began on 27 July with the participation of 43,661 volunteers, of whom 41,135 received a second dose or placebo. According to BioNTech's ceo, Ugur Sahin, his company and Pfizer will today (Friday) seek an emergency vaccine license from the U.S. Food and Drug Administration. Commenting on how quickly the application can be evaluated by the FDA's competent committee, he said that "approval or case-by-case licensing can be given in 2020, which will help us start sending the first doses before the end of the year," but avoided specifying how long the process would take to get the regulator's decision. The application for approval of the vaccine to the european authorities concerned will follow within a few days.
At the same time, production of the vaccine in Belgium and the USA is progressing feverishly. There are already 20,000 million people living in poverty. doses of the vaccine ready. Pfizer's Greek CEO Albert Burla, in an interview yesterday, said applications for approval of the vaccine would be filed in the coming days and distribution of the vaccine would begin hours after it received approval.
Mederna
The American pharmaceutical company Moderna uses similar technology to Pfizer's for its vaccine. MRNA-1273, as it is called, is also in Phase 3 of clinical trials involving 30,000 volunteers in the US. Moderna announced a few days ago that its vaccine is 94.5% effective. The two-dose moderna vaccine injects genetic material into the body, called mRNA , which the cells then use to mimic the protein spike that the coronavirus uses to invade them. The spike protein covers the surface of the virus and is one of the main goals of the body's immune response to eliminate infection. The interim results, announced Monday, are based on an analysis of confirmed cases of Covid-19 among volunteers who received placebos and those who received the vaccine, starting two weeks after the second dose was administered.
The Moderna vaccine is not expected to be available outside the US until next year. The company said it will have 20 million doses ready to be shipped to the US before the end of 2020 and hopes to produce between 500 million and one billion doses worldwide next year, while filling up its machines in partnership with Swiss Lonza Group AG to start European production by the end of the month, meaning it will be available as early as next spring.
AstraZeneca – University of Oxford
The vaccine developed by Oxford University and AstraZeneca was initially thought to be leading the race and is now a few weeks behind Pfizer. The main difference between ChAdOx1 nCoV-19 and Pfizer is that it is based on a "disabled" adenovirus, which causes a cold and is found in chimpanzees. In this adenovirus, however, Oxford scientists added genetic guidelines for the spike protein used by the new coronavirus to infect the human body, which means that the Oxford and AstraZeneca vaccine "teaches" the immune system to recognize SARS-CoV-2 and create an immune response.
The results of the final stage trials of oxford university's candidate vaccine against covid-19 will have "definitely" been known before Christmas, the lead researchers for the trials said today, adding that it is still too early to know its effectiveness although it said it was very pleased with the results released earlier today and which showed extremely good tolerance to the vaccine in people over the age of 55. However, EUR 40 million has already been manufactured in India. doses of this vaccine.
CanSino-Beijing Biotechnology Institute
CanSino's Ad5-nCoV is a vaccine and one of those that lead the race in China. The results of Phase II clinical trials showed that this vaccine produces "significant immune response in the majority of those who have received it, without serious side effects". Like that of AstraZeneca/Oxford University, this vaccine uses a virus called adenovirus to transfer genetic material from the new coronavirus protein to the human body. Although technically still in the second phase of testing, last June CanSino - whose largest shareholder is US pharmaceutical giant Elli Lilly, according to Refinitiv data - became the first pharmaceutical company to be licensed for limited use of its vaccine in humans and specifically for members of China's armed forces. However, it remains unknown when it will be made available to the public.
Sputnik V
Sputnik V, the race-leading coronavirus vaccine in Russia, uses two adenovirus strains and requires a second dose after 21 days to boost immune response. Although data on vaccine safety have not yet been published, the country's sovereign wealth fund argues that Sputnik V is 92% effective.
For the time being, as Elias Mosialos pointed out a few days ago, clinical trials of the Sputnik V Phase III vaccine have been approved and are under way in Belarus, the UNITED STATES, Venezuela and other countries, as well as Phase II-III in India.
Johnson & Johnson
Johnson & Johnson has already started the third phase of its vaccine clinical trials since September with the participation of 60,000 volunteers in the USA, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa, countries to which Britain has been added since yesterday.
Ad26.COV2-S uses an adenovirus to transfer the immune protein to the body, while Johnson & Johnson separately examines a vaccine against SARS-CoV-2, which could potentially be effective with one dose.
Novavax
The vaccine developed by Maryland-based U.S. biotech company Novavax is given in two doses with a difference of 21 days. At the end of September, the final phase of its trials began in Britain by vaccinating 10,000 people aged 18 to 84, while a few days ago the US Food and Drug Administration (FDA) turned on the green light to speed up clinical investigations of NVX-CoV2373 with the "fast track" procedure (i.e. speeding up research with more volunteers) in the US.
Source: iefimerida.gr
