Damage To Millions Of J&J COVID Vaccines At US Production Plant Could Delay Deliveries, While US Heads Into Fourth Wave Medicines & Vaccines 02/04/2021 • 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) A “human error” at a Johnson & Johnson production facility caused millions of doses of its COVID-19 vaccine to be spoiled and unusable. A mix-up with vaccine ingredients at a production site in Baltimore, Maryland, which is manufacturing both the Johnson & Johnson and AstraZeneca COVID-19 vaccines, has led to the contamination of 15 million J&J doses, which risks delaying national and global deliveries of the recently-approved vaccine. The pharma company, which is producing the world’s first single dose COVID-19 vaccine, announced Wednesday that a batch of doses failed its “rigorous quality control” standards. The doses were manufactured at a facility run by Emergent BioSolutions, which has production deals with both J&J and AstraZeneca. Federal officials have described the issue as human error, as workers at the plant reportedly confused components for the two vaccines in late February. It took several days for the mistake to be recognised, ruining a batch of millions of doses. The Emergent Bayview Facility in Baltimore has not yet, in fact, been authorised by the US Food and Drug Administration (FDA) to manufacture the J&J drug substance, but is currently under review for Emergency Use Authorization. The authorization has been held up by the FDA’s investigation into the site’s lapse in quality control. J&J will send experts in manufacturing, technical operations, and quality monitoring to supervise and support activity at the facility and gain more control over the manufacturing processes to avoid another public hiccup in production. The production of Johnson & Johnson’s one-shot COVID-19 vaccine, delivered through an inactivated adenovirus. Potential Delays in Vaccine Shipments J&J stressed, however, that the error won’t impact its upcoming delivery to the US of 11 million doses, forecasted to arrive this week from a manufacturing site in the Netherlands. However, the company had been expected to deliver 24 million more doses to US destinations from the Baltimore site in April. Although J&J officials said that they intend to remain on schedule with deliveries, US health officials said that they anticipate fluctuations in the vaccine delivery timetable, saying it could still take weeks to get the facility up to regulatory standards. The US has ordered a total of 100 million doses from J&J, which are to be shipped by the end of June. As of Thursday, approximately 7.8 million J&J doses were delivered and 3.4 million doses administered, according to the US Centers for Disease Control and Prevention. The J&J vaccine has widely been regarded as essential to speed up vaccination campaigns globally due to the fact it is a one-jab vaccine as well as its logistical advantages: it can be stored for at least three months at temperatures of 2-8°C and can be transported using existing cold chain technologies and standard vaccine distribution channels. “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, Global Head of Research and Development at Janssen Pharmaceuticals – a Belgian pharma company owned by J&J and responsible for developing the vaccine – in a press release published in late February. J&J expects to deliver one billion doses globally by the end of 2021, including some 400 million doses to African Union member states beginning in the third quarter of 2021. An agreement is also underway between J&J and Gavi, the Vaccine Alliance to provide 500 million doses to the WHO co-sponsored global COVAX Facility through 2022. The facility is trying to ensure more equitable distribution vaccines to low- and middle-income coutnries. However, insofar as J&J has already faced previous manufacturing delays in January, it remains to be seen if J&J will succeed in scaling up production to meet its commitments. CDC Warns – US Facing Fourth Wave of COVID-19 In ‘Critical Moment’ for Pandemic Meanwhile, the US could be facing an imminent fourth wave in the pandemic, with COVID-19 cases increasing in 25 states, and an average of 64,000 new cases reported daily over the past week, officials from the US Centers for Disease Control warned. The rise in cases coincides with multiple states loosening COVID restrictions on social distancing and other measures. Cases have increased by 12% from last week, accompanied by higher hospitalisation and death rates, with a seven day average of deaths at 940 per day. “This is a critical moment in our fight against the pandemic. As we see increases in cases, we can’t afford to let our guard down,” said Dr Rochelle Walensky, Director of the CDC, at a White House press briefing of the COVID-19 Response Team. “We need to keep taking the mitigation measures, like wearing a mask and social distancing, as we continue to get more and more Americans vaccinated every single day,” Walensky added, speaking at a White House press briefing on Wednesday. The B.1.1.7 variant, first identified in the United Kingdom, is responsible for 26% of the SARS-CoV2 variants circulating across the US, and it is the predominant strain in at least five regions of the country. “We do know it’s more transmissible – somewhere between 50 and 70 percent more transmissible than the wild-type strain,” said Walensky. “So to the extent that people are not practising those standard mitigation strategies, we do think that more infections will result because of B.1.1.7.” At the same time, however, several states have begun abandoning mask mandates and allowing for more social gatherings, which may provide an opportunity for the virus to spread as well as to mutatey, developing new deadly variants. “The failure to take this virus seriously [is] precisely what got us in this mess in the first place [and] risks more cases and more deaths,” said President Joe Biden at a press conference on Monday. Joe Biden, US President, delivering his presidential remarks on COVID-19 response and vaccinations on Monday. BIden pledged that the US will continue scaling up its vaccination campaign, setting the goal of having a vaccination site within five miles of every American by 19 April. “We are in a ‘life-and-death race’ against the virus. We are facing an accelerating threat,” said Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services, at the White House press briefing on Wednesday. This will simultaneously require continued adherence to public health measuring and the improvement of vaccine access nationally. Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span. 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