Covaxin trial results for 2-18 age group pave way for inoculation of kids Bharat Biotech said that Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. https://www.businesstoday.in/corona...way-for-inoculation-of-kids-317397-2021-12-30 Paving the way for COVID-19 vaccination of kids, thereby leading to a safe opening of primary and secondary schools, Bharat Biotech on Thursday announced clinical trial results of Covaxin conducted on children aged 2-18 years. Covaxin received approval for emergency use in children 12 - 18 years of age, following which, the government rolled out vaccination for kids from January 3, 2022, but for 15-18 age group. The Hyderabad-based pharmaceutical company today further said that Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity covaxin in healthy children and adolescents in the 2-18 age group. "The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity," the company said in a statement. "In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within 1 day. Pain at the injection site was the most commonly reported adverse event," it added. The results are however yet to be peer-reviewed. "Covaxin's clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children. Covaxin has now proven data for safety and immunogenicity in children," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech. In absence of vaccine choices for kids, the closure of schools has already caused learning loss among them. Bearing testimony to the fact, according to a report of UNICEF released in March 2021, in India, the closure of 1.5 million schools due to the pandemic and lockdowns in 2020 impacted 247 million children enrolled in elementary and secondary schools. In addition, there are over six million girls and boys who were already out of school even before the COVID-19 crisis began, the report had said. Even though several schools across states including Delhi started opening after the signs of COVID-19 curve bending downsides, lakhs of parents were reluctant to send their kids to schools without vaccination. "If we are not going to reverse the decision to reopen schools all children even younger than 15 years old need to be vaccinated," said Dr Vispi Jokhi, CEO at Mumbai based Masina Hospital. With cases of Omicron rising, the new and fast-spreading COVID-19 variant, school authorities and parents alike are willing to vaccinate their younger children. "Parents are not willing to send children to schools. Majority of classes don't see any strength of students. The first argument of parents is that they want their children to be vaccinated before sending them to schools," said a senior school teacher in government school in Delhi not willing to be named. Meanwhile, at least 961 cases of Omicron have been reported as on Thursday and number continues to rise. "Consistent evidence shows that the Omicron variant has a growth advantage over the Delta variant with a doubling time of 2-3 days and rapid increases in the incidence of cases is seen in a number of countries, including those where the variant has become the dominant SARS-CoV-2 variant, such as the United Kingdom and the United States of America," said Lav Agarwal, Joint Secretary at Union Health Ministry. Further, the government data showed that 90 per cent of adult population has been inoculated with at least one dose and 63.5 per cent of the eligible population has been fully vaccinated. India's cumulative COVID-19 count has breached 144 crore-mark on Thursday. The country's drug regulator has already approved Zydus Cadila's ZyCoV-D for those aged 12 years before Covaxin was a given a green signal for 15-18 years age group.
Novavax to submit COVID-19 vaccine EUA request to U.S. FDA next month https://www.reuters.com/business/he...mits-data-us-fda-covid-19-vaccine-2021-12-31/ Dec 31 - Novavax Inc (NVAX.O) will submit a request to the U.S. Food and Drug Administration to authorize its COVID-19 vaccine next month, further delaying the submission it had expected by the end of this year. The company's announcement on Friday follows submission of final data related to the vaccine's manufacturing processes to the regulator, which is a prerequisite for the emergency use authorization application (EUA). Novavax has had to delay its U.S. submission multiple times due to development and manufacturing setbacks. A report earlier this year said the methods Novavax used to test the efficacy of its vaccine had fallen short of regulators' standards. read more Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta. The company has said its vaccine is effective in generating an immune response against the Omicron variant, according to early data, suggesting that the existing COVID-19 vaccine can help combat the new variant. But it will continue to develop a vaccine tailored for Omicron, and expects to begin clinical studies in the first quarter of 2022. The biotech company in 2020 received $1.6 billion from the U.S. government to cover testing and manufacturing of a potential COVID-19 shot, with the aim of delivering 100 million doses. (https://reut.rs/3yHnJLr) The two-dose, protein-based vaccine has so far got authorizations from European Union regulators and the World Health Organization. It has also secured authorizations in India, Indonesia and the Philippines, where Novavax's partner Serum Institute of India will supply. Novavax is also awaiting approval in Japan, where its vaccine would be manufactured and distributed by Takeda Pharmaceutical (4502.T).
Japanese scientists create lifelong immunity COVID-19 vaccine According to the publication [paywall], researchers at the Tokyo Institute of Medical Sciences took the smallpox vaccine, which was created in the 18th century in Britain, as the basis for a new drug. Scientists want to insert the spike protein of the SARS-CoV-2 virus into the recombinant vaccinia virus. They are convinced that this combination will create quality, lifelong protection against coronavirus infection. "This vaccine can promote the production of antibodies and provide lifelong immunity. A single dose is effective for over 20 months," the publication said.
Also MAGAS do hundreds of other things they are told to do without any issue but suddenly drew hte line when their Fuhrer lost the election. Incidentally trump upset his loyal supporters when he supported the vaccine.
I am not doubting that scientists in Japan are working on a universal permanent Covid vaccine. Many countries are working on this -- they should coordinate their research & funding. There have been many multiple hopeful articles about strides in progress -- but the reality is that the next-generation universal, permanent Covid vaccine is probably still five years out. I am poking fun that you linked a very low credibility source for this information, pravda.ru -- which is effectively the direct misinformation publication arm of the Kremlin. To boot you even linked the article in Russian. Certainly there are better sources for this information about Japanese research. https://www.pravda.ru/news/health/1673059-japonija_vakcina_covid19/
Two shots of Pfizer vaccine 70 per cent effective against Omicron hospitalization, research shows https://www.ctvnews.ca/health/coron...cron-hospitalization-research-shows-1.5722568 New research out of the Gauteng province of South Africa is providing more data on how effective the Pfizer-BioNtech COVID-19 vaccine is against the Omicron variant. Published in the New England Medical Journal, the study found that a two-dose regimen of the Pfizer vaccine is 70 per cent effective against hospitalization with the Omicron COVID-19 variant. As of Nov. 15, the Omicron variant was being detected in more than 75 per cent of COVID-19 tests that were being sequenced in South Africa, and the variant has quickly spread to be the dominant strain in many countries. Canada saw a surge of COVID-19 cases over the holidays, with both Quebec and Ontario breaking previous one-day records, which experts say estimate to be less than the true scope of national case counts due to testing delays and laboratory backlogs. In order to assess how effective two doses of the Pfizer vaccine are against the Omicron variant in preventing hospitalizations due to coronavirus, researchers used data from South African care organization Discovery Health to compare data sets of people diagnosed with the Delta variant with those who had the Omicron variant. The study’s data included PCR test results, medical history, chronic illnesses and body mass index to calculate the number of COVID-19 risk factors per patient, according to the guidelines of the U.S. Centers for Disease Control and Prevention. Among the fully-vaccinated study participants, researchers compared the Pfizer vaccine’s effectiveness against COVID-19 hospitalization associated with the Omicron variant from Nov. 15 to Dec. 7 in South Africa, which they referred to as the period of dominance, and comparedit with data from Sept. 1 to Oct. 30, when Delta was the dominant variant. Researchers analyzed 133,437 PCR test results related to the Delta variant from Sept. 1 to Oct. 30, of which 29 per cent were obtained at least 14 days after the patients had received the second dose of the vaccine. They also analyzed 78,173 PCR test results related to the Omicron variant, in which 41 per cent were obtained at least 14 days after the second dose of the vaccine. The overall test positivity results were 6.4 per cent during Delta’s dominant period compared with 24.4 per cent during Omicron’s dominant period. However, the COVID-19 admission rate was 10.8 per cent during the Delta dominant period versus 2.2 per cent in the Omicron dominant period, as a percentageof positive PCR test results. During the Omicron-dominant period, researchers found a vaccine effectiveness of 70 per cent, compared to 93 per cent associated with the Delta dominant period studied against hospitalization for COVID-19. During the Delta-dominant period studied, 684 unvaccinated people were admitted to hospital with COVID-19, compared to 220 during the Omicron-dominant period. Of those vaccinated with one dose of the Pfizer vaccine, 71 were admitted to hospital with COVID-19 during the Delta period, compared to 34 during the Omicron period. Of the study participants who had two doses of the Pfizer vaccine and had a positive PCR test result less than 14 days after their second dose, 13 were admitted to hospital with COVID-19 during the Delta period, while zero were admitted during the Omicron period. However, of those who had two doses of the Pfizer vaccine and had a positive PCR test 14 days or more after their second dose, 77 were admitted to hospital with COVID-19 during the Delta period, compared to the 121 admitted during the Omicron period. The study states that during the Omicron-dominant period they “saw a maintenance of effectives of the Pfizer vaccine, albeit at a reduced level” against hospital admission for COVID-19. “The addition of a booster dose of vaccine may mitigate this reduction in vaccine effectiveness,” the researchers wrote.