From November 1st to 2nd, 2018, the annual World Health Organization (WHO) Prequalification (PQ) consultation will be held in Kunming, China. Unlike previous years, this year’s consultation will only take the one-on-one format, namely the World Health Organization Vaccine Pre-Certification Review Team and small meetings of various domestic vaccine manufacturers. Although the part of the centralized consultation meeting will be cancelled, which means companies and international organizations are unable to discuss and share the importance of pre-certification, but it’s believed that after several years of consultations, everyone has already cooked up the importance and significance of pre-certification. Evidence? This year’s 14 vaccine manufacturers actively participate in the one-on-one consultation is the best proof. As of November 2018, there were 4 manufacturers and vaccines that successfully passed the pre-certification of vaccines in China, namely, Chengdu institution’s Yinao, Hualan’s Liugan, Kexing’s Miejia and Beishengyan’s bOPV. At the PQ consultation meeting in Beijing ...
New real-world data has suggested that Russia’s Sputnik V vaccine is 97.6% effective against COVID-19, the Gamaleya Institute and the Russian Direct Investment Fund (RDIF) announced yesterday. The new efficacy rate is based on the analysis of data from 3.8 million Russians vaccinated with both components of Sputnik V from between 5 December 2020 and 31 March 2021. In a statement, the RDIF said the Ministry of Health of Russia maintains a register of those who have been vaccinated, as well as citizens who have been infected with COVID-19. According to the data, the infection rate starting from the 35th day from the date of the first injection was 0.027%. The incidence among the unvaccinated adult population was found to be 1.1% for a comparable period starting from the 35th day after the launch of the mass-scale vaccination in Russia. The data and calculations used to determine the vaccine’s efficacy will be ...
Pfizer and BioNTech have revealed positive top-line data for their COVID-19 vaccine – BNT162b2 – in adolescents aged 12 to 15 years old. The vaccine demonstrated 100% efficacy in a Phase III trial in adolescents aged 12 to 15 years old, with or without prior evidence of SARS-CoV-2 infection. BNT162b2 also produced ‘robust’ antibody responses in the younger population, exceeding those reported in an earlier trial in participants aged 15 to 25 years old. The jab was also found to be well tolerated in the 12 to 15 age group. The companies are now planning to submit the data to the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) to extend the use of the vaccine for this age group ‘as quickly as possible’. Pfizer and BioNTech will also continue to monitor the participants for long-term protection and safety for an additional two years after their ...
AstraZeneca (AZ) has issued an update on the safety of its COVID-19 vaccine, saying a review showed no evidence of an increased risk of blood clots among people vaccinated with its jab. In a statement, AZ said that across the EU and UK, there have been 15 events of deep vein thrombosis (DVT) and 22 events of pulmonary embolism reported among people given its vaccine – based on the number of cases the company has received as of 8 March. AZ added that a ‘careful’ review of all available safety data – including more than 17 million people vaccinated in the EU and UK with its COVID-19 vaccine – has shown ‘no evidence of an increased risk of pulmonary embolism, DVT or thrombocytopenia, in any defined age group, gender, batch or in any particular country.’ The cases reported so far are ‘much lower’ than what would be expected to naturally ...
A new social media campaign, launched by the UK government and the NHS, will allow people to show their support for the COVID-19 vaccine roll-out from today. The initiative will enable users to update their social media profiles with specially designed profile frames and graphics. This allows people to show either that ‘I’ve had my vaccine’ or make a pledge that ‘I will get my vaccine’ in an effort to bolster the nationwide vaccination programme. The range of Facebook frames and Instagram GIFs will be ready for use on social media from 19 February, and will be available in 13 languages from 22 February. “We know people are turning to social media more than ever to stay in touch with family and friends,” said Health and Social Care Secretary Matt Hancock. “These new graphics will make it easy for people to share their support for the jab and thank the ...
The NHS has now offered COVID-19 vaccinations to residents at all eligible care homes in England, according to official figures. In a statement, the health service said this marked a ‘major milestone for the NHS vaccination programme’, with vaccines having been offered to people living in over 10,000 care homes with older residents. The NHS added that a small number of care homes have had visits by vaccination staff deferred for safety reasons, although these homes will be visited as soon as possible. “Today marks a crucial milestone in our ongoing race to vaccinate the most vulnerable against this deadly disease,” said Prime Minister Boris Johnson. “We said we would prioritise and protect care home residents, and that is exactly what we have done,” he added. Johnson also added that 8.9 million people have now received the first dose of a COVID-19 vaccine. Older care home residents and staff were ...
Many vaccines have highly specific storage requirements that if not met can reduce their potency significantly, even rendering them completely ineffective. Vaccines must be stored correctly from the moment they are manufactured until they are ultimately administered, and this is the shared responsibility of the manufacturer, distributor, and healthcare provider. What are the most common storage conditions? The vast majority of vaccines should be stored at between 2-8⁰C in a refrigerator, with a preferred average of 5⁰C, though some should remain frozen in a range between -15 to -50⁰C. Additionally, many should be protected from light and are packaged appropriately, as UV-light can damage them. Many live-virus vaccines can tolerate freezing temperatures and rapidly deteriorate once defrosted, while inactivated vaccines more commonly require stable temperatures of 2-8⁰C and are damaged at temperature extremes. The commonly administered measles, mumps, rubella (MMR) vaccine can be stored either frozen or refrigerated, while the MMRV vaccine ...
Vaccines must be stored in specific conditions to avoid degradation, usually defined specifically by the manufacturer. Across the stages of manufacture, distribution, storage, and ultimately administration, these conditions must be adhered to, and this process is known as the cold chain. Should the cold chain be broken at any point during transport or storage, via exposure to temperate extremes, then the potency of the vaccine risks being reduced, or the vaccine is even rendered completely ineffective. The vast majority of vaccines must be refrigerated at between 2-8⁰C, with a preferred average of 5⁰C with minimal fluctuations. Specially designed lab refrigerators are usually used for this purpose, which has comparatively minimal temperature fluctuation across days and seasons, do not present any temperature extremes on any interior surface, and may bear an external temperature display that automatically logs the internal temperature at particular time intervals. Many live vaccines tolerate freezing, and depending on the ...
The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020. This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, ...
30 November 2020 The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has ...
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