Let us get into the latest development in the biotech world. This week, a large part of the world is experiencing a brutal third wave of the Covid-19, and the fight against the more contagious variants of the virus that appeared in Brazil and South Africa continues. Around the globe, countries are mobilizing their efforts to perform mass vaccination rollouts and the biotech companies are trying to come up with new treatment methods and new vaccines that would be easier to manufacture and distribute. At the same time, countries around the globe are starting to approve new vaccines that are freshly out of the clinical trials and make plans for the mass vaccination that will be happening worldwide for the next months. Both Sinovac and AstraZeneca vaccines have shown to be effective in protecting against the Brazilian variant of the Covid-19 virus. More than 40 countries are already interested in India’s home-grown vaccine after the 81% efficacy rate in the late-stage trials and India’s drug regulator has eased up on the usage rules. Meanwhile, in the United States, the first test kit to be bought without a prescription and used at home has been approved by the FDA, and GlaxoSmithKline Plc and Vir Biotechnology have developed an antibody treatment that reduces the risk for serious health consequences or death by Covid-19. Let’s look back at what was happening in the biotech world this past week.
Today, a Thai official has confirmed that as Thailand is preparing for mass vaccination of its population, Moderna is about to submit the official application for approval of the Covid-10 vaccine until the end of March. Except for Moderna, India’s Bharat Biotech vaccine has already started sending documents for official approval in Thailand.
The other vaccines that have already been approved in Thailand are Sinovac Biotech and AstraZeneca.
So far, Thailand recorded 26,500 Covid-19 cases and 85 deaths.
A panel of expert drug regulators in India has come to a decision to ease up the rules of use of the government-backed home-grown Covid-19 vaccine that has shown to be 81% effective (per the late-stage trials).
“After detailed deliberation, the committee recommended for the omission of the condition of the use of the vaccine in clinical trial mode,” the Central Drugs Standard Control Organization said on Thursday on their official website. “However, the vaccine should be continued to be used under restricted use in emergency situation condition.”
The first data from a clinical study conducted in Brazil shows that the Chinese Sinovac vaccine is an effective protection against the Brazilian P1 variant of the disease.
The news was reported by the governor of Sao Paulo state, Joao Doria, on Wednesday. The news comes as particularly important since the Sinovac jab is the one primarily used in Brazil to vaccinate the population.
The insomnia drug developed by the Swiss drugmaker Idorsia has not been accepted for review by the U.S regulators. The medicine daridorexant competes with a similar drug, Merck’s Belsomra which had a $327 million in sales. Having said that, Idorsia hopes for the competitive edge coming from the fact that the trials illustrating that both night and day functioning is improved and that the medicine amount to approximately $5 per day which is a competitive price.
“Should approval be received, the company anticipates a launch in the U.S. in the first half of 2022,” Idorsia said.
The drug has also been submitted to the European regulator, European Medicines Association. Having said that, experts believe that the European market is more conservative of sleeping medicine than the American one and that the FDA approval may come much sooner.
Some early reports show that the Sputnik V vaccine developed in Russia could be produced in Western Europe after a preliminary agreement was struck between Moscow’s RDIF sovereign wealth fund and the Swiss-based pharma Adienne.
According to the deal, the vaccine would be produced in Italy. Having said that, before that can happen, the Italian regulators must approve the vaccine. Although the vaccine has shown to be 92% effective according to the peer-reviewed late-stage trials, the European Medicines Agency (EMA) has still not given its approval to the vaccine and the officials in Brussels say that it will be discussed if at least four members of the bloc requested.
Having said that, three out of four Visegrad countries – Slovakia, Hungary, and the Czech Republic have already approved or are in the process of approving the vaccine. Thus, it is reasonable to expect that the European Union may start negotiations to buy the Russian vaccine soon.
The deal with Italy is paving the way for the first production facility of Sputnik outside of Russia and the production could speed up the process significantly, with the capacity of producing 10 million doses of Sputnik V until the end of the year.
“This agreement is the first of its kind with a European partner,” Vincenzo Trani, head of the Italian commerce chamber, said in the statement. “It can be called a historic event, which is proof of the good state of relations between our countries and shows that Italian companies can see beyond political differences.”
Bharat’s COVID Vaccine Shows High Immune Response
India’s Bharat Biotech vaccine has proved effective, a peer-reviewed study claimed. While the clinical trials have shown high levels of antibody response, follow-on research is recommended, to evaluate the effects on the children and elderly.
More than 40 countries are interested in India’s vaccine that has so far shown 81% effectivity in the late-stage trials. Similar to the Pfizer and Moderna vaccine, India’s one is a two-dose jab with 2 weeks in between the doses.
India which is the biggest vaccine maker in the world expects to vaccine 300 million people by August. India has had one of the most tragic unfoldings of the pandemic, with 11.24 million people infected and more than 150 000 deaths.
On Friday, it was reported by Reuters, that the University of Exford study found the Covid-19 vaccine by AstraZeneca effective against the P1 variant of the virus, first discovered in Brazil.
The full results of the study are to be released soon, having said that, data indicated that the AstraZeneca vaccine will not need to be modified in any way in order to efficiently protect against the Brazilian Covid-19 virus.
Early results have shown that the vaccine is much less effective against another highly contagious variant of the virus, referred to as the South African virus. After the news was reported, South Africa has temporarily stopped the rollout of the AstraZeneca vaccine.
The head of disease control authorities in China said on Friday that the country’s production capabilities can be sufficient for 40% of the population vaccinated by mid-2021 and large enough for up to 80% of the Chinese nation to be vaccinated by the beginning of 2021.
Gao Fu, the director of the Chinese Center for Disease Control and Prevention, said that the estimate is his personal view and has not been backed up by any official forecast.
So far, 52 million doses were administered in China which is much less than in the United States or Israel.
GlaxoSmithKline Plc and Vir Biotechnology Inc. announced on Thursday that the Covid-19 antibody therapy they developed shows a large reduction of hospitalization and death among the at-risk patients.
The trials have progressed much faster than it was anticipated and in their joint statement, companies said the emergency authorization in the United States will be applied for as soon as the late-stage trials.
The treatment, VIR-7831, reduced the numbers of patients who were hospitalized or died by 85% compared to a placebo, the companies said.
The FDA has just authorized the first molecular Covid-19 test that can be bought without a prescription and performed at home.
The Cue Health test is a nasal swab that can be used in adults and children as young as two. The test works both for those with symptoms and those without symptoms and the results come within 20 minutes.
The test kit includes a test, sample collecting wand, and a cartridge reader that can be connected to a smartphone app. The false-negative rate was shown to be 4% while the false-positive rate was 0.
“For the first time, consumers can access laboratory-grade testing at home,” said Ayub Khattak, co-founder, and CEO of Cue Health. “With this FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem,”
The company expects to produce 100 000 tests per day by the summer of 2021.
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