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‘We will be ready to distribute within hours of authorization’

The companies announced the conclusion of the vaccine’s Phase 3 trial earlier this week: reporting 95% efficacy. They also announced that they had gathered the two months of safety data required by the US’ Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission. Dr. Albert Bourla, Pfizer Chairman and CEO, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” Other regulatory submissions will follow ‘immediately’ Pfizer and BioNTech have already started rolling reviews of the ...
- Source: drugdu
- 401
- November 23, 2020
Covid-19 vaccine
Gaps remain in immunization logistics and real-time tracking of vaccine storage and demand

How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds. “Overall, securing an end-to-end unbroken cold chain – from vaccine manufacturer to the site of injection, is an extremely hard thing to do. It requires constant monitoring and remedial action. “Why? The constituent parts of the cold chain are vastly distinct. They are separately operated but uniformly coordinated systems within an overall vaccine supply chain,” said Raja Rao, director, cold chain strategy and markets, B Medical Systems. Storage Vaccine distribution is complexity at its finest, he said. “It is almost always the case that the cold chain is relatively strongest between the site of manufacture and arrival at the port of entry, from Belgium to Nairobi, for example. This is because vaccines are air-shipped in modern, cold storage containers, ...
- Source: drugdu
- 325
- November 22, 2020
Covid-19 vaccine
FDA authorises first home self-testing kit for COVID-19

RELATED TAGS: Lucira Health, Us, emergency use authorization, COVID-19 The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home. Lucira says the kit takes around two minutes to use; and gives rapid results within 30 minutes. The $50 kit – which fits in the palm of the hand – provides a simple ‘positive’ or ‘negative’ reading. The kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. It is authorized for prescription home use with self-collected nasal swab samples in people aged 14+ who are suspected of having COVID-19 by a healthcare provider. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at ...
- Source: drugdu
- 348
- November 21, 2020
Covid-19
European Commission approves Sanofi’s recombinant influenza vaccine

The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union. The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union. The vaccine is already approved in the US under the tradename Flublok Quadrivalent (where it is also the only recombinant influenza vaccine). The first European launches could become available for the 2021-2022 influenza season in certain countries; with the main launch set for the 2022-2023 season. The flu vaccine’s new recombinant technology is also being used in Sanofi’s lead COVID-19 vaccine candidate with GSK: which is expecting to launch a pivotal Phase 3 study before the year is out. This could be followed by a request for regulatory approval in ...
- Source: drugdu
- 383
- November 20, 2020
influenza vaccine
China’s Sinovac reports mixed findings in early coronavirus vaccine trials

A man works in a laboratory of Sinovac Biotech in Beijing on Sept. 24. The Chinese company is developing an experimental coronavirus vaccine. (Thomas Peter/Reuters) By Eva Dou November 18, 2020 at 5:09 p.m. GMT+8 Sinovac Biotech, one of China’s coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac’s vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer, which have separate experimental vaccines, had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. These early results put Sinovac on the back foot to prove its vaccine is effective in ongoing Phase 3 trials. “That is a concern,” ...
- Source: drugdu
- 148
- November 19, 2020
Covid-19
Natural products and herbal medicines show promise in fight against COVID-19

Researchers in China and the United States have called for more research into the potential prophylactic effects of natural products and herbal medicines on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent coronavirus disease 2019 (COVID-19). In an article recently published in the journal Frontiers in Pharmacology, the team discussed natural products that have exhibited an inhibitory effect on SARS-CoV-2 and herbal medicines that have been tested as potential therapies for COVID-19. “In this review, we aimed to provide a new perspective regarding COVID-19 prevention,” writes Jia-xu Chen from Jinan University in Guangzhou, and colleagues from the University of Houston, and the University of California. The researchers suggest that while the world awaits effective treatments and a commercially available vaccine, the repurposing of natural products and herbal medicines as prophylactics represents a promising approach to at least slow the transmission of SARS-CoV-2. “In the interest of public health, this ...
- Source: drugdu
- 1,343
- November 18, 2020
Covid-19
Moderna expects to know by the end of the month whether its Covid-19 vaccine works

By Elizabeth Cohen and Lauren Mascarenhas, CNN Updated 0510 GMT (1310 HKT) November 12, 2020 Fauci says vaccine could be available to all by April 02:52 (CNN)Moderna has finished accumulating data for a first analysis of its Covid-19 vaccine and expects to have an announcement on the vaccine’s efficacy by the end of the month, the company said in a statement Wednesday. Pfizer announced Monday that its coronavirus vaccine is more than 90% effective. Moderna is conducting a clinical trial of 30,000 participants, with half receiving the vaccine and half receiving a placebo, which is a shot of saline that does nothing. In order for Moderna’s vaccine to be considered for authorization by the US Food and Drug Administration, at least 53 study participants needed to become ill with Covid-19. The trial hit that 53 mark Wednesday, but Moderna doesn’t know if the participants who became ill received the vaccine or the ...
- Source: drugdu
- 351
- November 17, 2020
Covid-19
Poor nutrition in school years may have created 20 cm height gap across nations

A new global analysis led by Imperial College London, and published in journal The Lancet, has assessed the height and weight of school-aged children and adolescents across the world. The study, which used data from 65 million children aged five to 19 years old in 193 countries, revealed that school-aged children’s height and weight, which are indicators of their health and quality of their diet, vary enormously around the world. There was a 20 cm difference between 19-year-olds in the tallest and shortest nations — this represented an eight-year growth gap for girls, and a six-year growth gap for boys. For instance, the study revealed that the average 19-year-old girl in Bangladesh and Guatemala (the nations with the world’s shortest girls) is the same height as an average 11-year-old girl in the Netherlands, the nation with the tallest boys and girls. The international team behind the study warn that highly variable ...
- Source: drugdu
- 290
- November 16, 2020
height nutrition
Second wave of COVID-19 in UK has reached “critical” stage, says study

Caused by the highly contagious pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the feared but expected the second wave of coronavirus disease 2019 (COVID-19) has already hit the UK. This can be seen in the current high prevalence of infection across the country. Thus, the virus is poised to take a high toll on the country’s public health – and ultimately many of its citizen’s lives – unless prompt containment measures are put in place, says a recent study published on the preprint server medRxiv.* The first wave of the pandemic in the UK occurred from March and April 2020, characterized by a high infection peak and then a steep and continuing decline in new infections that lasted until the beginning of August. From this point on, there has been a steady rise in infections, with the reproduction number (R) staying above 1, indicating a propagating epidemic. Increasing Prevalence ...
- Source: drugdu
- 198
- November 15, 2020
Covid-19
Discovery of novel hidden gene in SARS-CoV-2

Understanding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the virus that causes the coronavirus disease 2019 (COVID-19) – is crucial for both vaccine and treatment development. Since the pandemic started in December 2019, many studies have explored the virus’s origins and how it infects humans. This way, scientists and clinicians have an idea of how to combat the infection. A team of researchers from Germany, Taiwan, and the United States has identified and characterized a new hidden gene in SARS-CoV-2 that is also present in Guangxi pangolin coronaviruses – though, curiously, absent in closely related pangolin and bat coronaviruses. What are overlapping genes? The coronavirus pandemic raises urgent questions about the properties that allow viruses in animals to jump to humans. Called zoonosis, these types of diseases have impacted human life for years, including the AH1N1 virus, bovine tuberculosis, glanders, and bubonic plague, among others. To further understand zoonotic diseases, ...
- Source: drugdu
- 286
- November 14, 2020
Covid

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