Johnson & Johnson Prepares To Release COVID Vaccine Trial Data, While US Announces Changes To Vaccination Policy Medicines & Vaccines 14/01/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The development of Johnson & Johnson’s adenovirus COVID-19 vaccine candidate. Johnson & Johnson is set to release its Phase 3 COVID-19 clinical trial results in two weeks and immediately file for emergency authorization from the US Food and Drug Administration (FDA) – an announcement that is likely a harbinger of positive results. This news on the development of the first one-shot COVID-19 vaccine, accompanied by the interim results of the Phase 1/2 trial, comes as countries globally face increasing infection rates and troubled vaccination programmes. In comparison with the existing two dose vaccines, the one-shot option could offer significant advantages for the speed of full immunisation, logistics and storage – as the Johnson & Johnson vaccine can be stored in a refrigerator for months instead of requiring cold chain storage – if the data shows a high level of effectiveness. The interim Phase 1/2 data, published in the New England Journal of Medicine on Wednesday, revealed that a single dose of the vaccine elicited a strong immune response, with neutralizing antibodies detected in over 90% of trial participants, regardless of their age group. The elicited immune responses were stable, lasting at least two and a half months in participants aged 18 to 55 years. Despite the positive reports of the potential upcoming release of a single dose vaccine – described as a “game changer” by Moncef Slaoui, Operation Warp Speed Chief Scientific Adviser – the company is experiencing delays in manufacturing and is estimated to be two months behind schedule. Slaoui announced at a press conference on Tuesday that analysis of trial data and the emergency use authorization submission to the FDA will take place before the end of the month. Moncef Slaoui, head of Operation Warp Speed, at a press conference on Tuesday. “We project to have a single digit million number of doses available in the second half of February. We’re trying to make that number get as close to a double digit number as possible. Then a larger number in March and a much larger number in April,” he added. If the vaccine is authorised for emergency use by the US FDA, approximately three million doses could be delivered by the end of February, instead of the planned 12 million. The 100 million doses pledged to the US through Operation Warp Speed could be pushed back several months into Spring. US to Release COVID Vaccines Set Aside for Second Doses Meanwhile, the Trump Administration has decided to release all available doses of COVID-19 vaccines, instead of reserving half to ensure access to second doses. The move took place on the same day that a new record for the most COVID-19 deaths in one day was hit. Map of incidence rate of COVID-19 globally, at 9pm EST, 13 January 2021. On Tuesday evening, the US recorded 4,327 deaths. Hours earlier at a press conference, Alex M. Azar II, the Department of Health and Human Services Secretary, announced the expansion of vaccine eligibility to all individuals over 65 years of age, along with the broadening of locations to administer vaccines. The release of the second doses does not imply that the schedule of vaccination will change or that the second dose will be delayed, as in the UK. “Our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine,” said Azar. “Based on the science and evidence we have, it is imperative that people receive their second doses on time – that’s what the science says, and ignoring that would be reckless.” According to the federal government, the US has averaged around 700,000 vaccinations daily in the past week and has reached a total of 9 million administered vaccinations. 95% of long-term care facilities will have access to COVID-19 vaccines by the end of next week. The policy shift has been made “as supply expands to meet demand,” said Azar. The guidelines for states have now changed from recommending adherence to the phases put forth by the US Centers for Disease Control (CDC) to advising states to open inoculations to individuals age 65 and over and all people under 65 with a co-morbidity. Alex Azar, Secretary of Health and Human Services, at a press conference on Tuesday. “This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied,” said Azar. The new guidance was criticised by some experts for its potential to disrupt existing timelines, undermine the prioritisation of essential workers, healthcare professionals, and vulnerable populations, and create more confusion in the vaccination program. “A lot of our members are feeling like this is just beginning to move too fast,” said Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials. “What we’re going to get to is a first-come, first-serve approach to vaccine distribution, and that’s just not going to be equitable.” Over 50 million people are now cleared to receive a vaccine, which has intensified pressure on states to register and schedule appointments for inoculation. “This is creating a lot of confusion and chaos and anxiety days before a new administration comes in,” said Claire Hannan, executive director of the Association of Immunization Managers, in an interview with NPR. It is currently unclear if this new vaccination policy will continue under Joseph Biden Jr.’s new administration, which will begin on 20 January. Biden’s transition team announced last week their plan to release the available supply of vaccines, however, further details on his vaccination plan are expected this week. Fauci Expresses Support for the US to Join WHO’s C-TAP Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a leading immunologist in the US, conveyed his strong support for the US to join the WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP is the WHO co-sponsored pool for sharing COVID vaccine patents and technologies – but so far it has barely gotten off the ground since few countries and no pharma companies have joined. “That’s an easy answer: yes, yes, yes,” said Fauci when asked about his support for the program at an event organised by Partners in Health. “I fully believe that whether it’s HIV/AIDS or whether it’s COVID, we are part of the global community, we are a rich country, we have to participate in [this] kind of solidarity…and join forces with the rest of the nations to make sure that billions and billions of doses are manufactured so that the poorest countries can get the same sort of access to vaccines as we do in Washington and in New York City.” Very glad to hear Anthony Fauci's strong words of support for @WHO & partners' work to ensure equitable access to #COVID19 tools & technologies. Indeed, we are applying lessons from the past, incl. from the HIV/AIDS crisis. Only if we #ACTogether can we beat global health threats https://t.co/mjDrlwNptM — Tedros Adhanom Ghebreyesus (@DrTedros) January 13, 2021 Sharing the data, knowledge, know-how, and biologic materials that are instrumental for manufacturing COVID-19 vaccines and therapeutics would enable manufacturers in low- and middle-income countries to produce COVID-19 technologies and assist with issues of vaccine shortages and the inequitable distribution of vaccines. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span, John Hopkins. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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