Johnson & Johnson’s One-Dose COVID Vaccine Approved By FDA, But Officials Warn That Initial Vaccine Rollout Could Be Uneven Medicines & Vaccines 01/03/2021 • Madeleine Hoecklin & Kerry Cullinan 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) Vials of Johnson & Johnson’s vaccine that was granted emergency use authorization by the FDA on Saturday. The United States Food and Drug Administration (FDA) granted Johnson & Johnson’s single-dose COVID-19 vaccine emergency use authorization on Saturday, clearing the way for it to become the third COVID vaccine to be administered in the US starting on Tuesday. Initial supplies to the US market, however, are likely to be limited for at least the first few weeks due to issues with scaling up manufacturing, officials warned. Meanwhile, there was no clear timetable yet for the provision of the vaccine to the WHO co-sponsored global COVAX facility – which is supposed to receive some 500 million doses. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Janet Woodcock, Acting FDA Commissioner, in a press release. The vaccine was 66% effective overall in preventing moderate to severe infection and 85% effective in preventing severe disease, according to results of Phase 3 trials with 43,783 participants. The level of protection against moderate to severe infection provided by the vaccine varied by country and region, with the US recording an efficacy rate of 72%, Latin America reporting 66%, and South Africa recording 57%. This suggests that the vaccine is slightly less effective against the B.1.351 variant, first identified in South Africa. Although lower than the 90%-plus efficacy ratings of the Moderna and Pfizer/BioNTech vaccines, as well as trial results obtained by Novavax and AstraZeneca, J&J’s vaccine offers dosing and handling advantages. Early Supply of J&J Vaccine Could Be Scarce US hospitals are expecting to begin receiving the initial 3.9 million doses of the J&J vaccine on Tuesday, but officials from the Biden administration have warned that the supply could be uneven for the next few weeks. J&J signed a US$1 billion agreement with the US for 100 million doses, with the option to purchase an additional 200 million doses. The company is planning to deliver 16 million doses to US markets by the end of March and 100 million doses during the first half of 2021. Initially, the plan had been to deliver 37 million doses by the end of March, but the pharma company is facing difficulties scaling up its production, specifically at its manufacturing plant in Baltimore. The first round of 3.9 million doses are being delivered from the company’s factory in the Netherlands. The rest will be produced in the US. “We do not expect any additional deliveries next week and we expect deliveries to be uneven during the weeks of March,” said a senior Biden administration official at a press briefing on Sunday. “We’re getting doses out the door as soon as they’re available to ensure vaccines get into the arms as quickly as possible.” We'll distribute the vaccine equitably to states, Tribes, & territories as quickly as Johnson & Johnson can produce it. And as we have with Pfizer and Moderna, we will use every tool at our disposal to expand the manufacturing effort and get shots in arms as quickly as possible. — White House COVID-19 Response Team (@WHCOVIDResponse) February 28, 2021 J&J Vaccine Under Review By EMA and WHO The European Union has a purchase agreement with J&J, securing 200 million doses, with the option to order another 200 million. “We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021,” said Stoffels, Chief Scientific Officer of J&J, in a statement. Meanwhile, much to the dismay of medicines advocates, the promised distribution of J&J vaccines to the global COVAX facility may start even later. J&J and GAVI, The Global Vaccine Alliance, recently announced an agreement to supply some 500 million doses of the vaccine to the global COVAX facility by 2022. “Johnson & Johnson is ready to join the fight on the ground against COVID-19 and eager to help bring this pandemic to an end – not just in the United States, but throughout the world,” said Alex Gorsky, CEO of J&J, in a statement. But it remains unclear how soon rollout of the vaccine through COVAX might begin, particularly in light of the demands in the United States and Europe. And medicines advocates have already complained that poorer countries risk being pushed to the back of the bus in terms of getting access to a vaccine that is much easier for many countries to manage. J&J’s modest temperature requirements, one-shot regimen, and demonstrated efficacy against the B.1351 variant that is spreading across southern Africa have all made it an attractive candidate to LMICs. J&J submitted applications in mid-February to the European Medicines Agency (EMA) for a “conditional marketing authorization” and to the WHO for an emergency use listing (EUL) – which would clear the way for distribution through COVAX. The EMA plans to meet in mid March to issue a decision. Benefits of J&J Vaccine The J&J vaccine only requires a single dose and can be stored for up to three months at standard refrigeration temperatures (2 to 8°C) and transported using existing cold chain technologies and standard vaccine distribution channels. In contrast, the Moderna vaccine can only be stored at refrigeration temperatures for 30 days and Pfizer’s vaccine can be stored for two weeks. If the vaccines need to be stored longer, they have to be kept between -80ºC to -60ºC for Pfizer’s vaccine and between -25°C and -15°C for Moderna’s. Johnson & Johnson will ship the vaccine using existing cold chain technologies because the temperature requirements are not as strict as for Pfizer’s and Moderna’s vaccines. J&J’s vaccine uses a more widely tested method than the Pfizer and Moderna mRNA vaccines. It uses an adenovirus to provide the cells with the genetic material to make the “spike” protein of SARS-CoV2. This triggers an immune response against the virus. “We believe Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, Chief Scientific Officer of J&J, in a press release. “A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.” Following the FDA’s decision, the US Centers for Disease Control and Prevention (CDC) endorsed the J&J vaccine for use in people aged 18 and older, including the vaccine in the national immunisation program. “This vaccine is also another important tool in our toolbox to equitably vaccinate as many people as possible, as quickly as possible,” said Rochelle P. Walensky, CDC Director, in a statement released on Sunday. “Having different types of vaccines available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers,” Walensky added. Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, described the three vaccines as “highly efficacious in many ways, including, importantly, preventing severe or critical disease” in an interview with CBS News on Sunday. “People should take the one that’s most available to them,” said Fauci in an interview with NBC News. “If you go to a place and you have J&J and that’s the one that’s available, I would take it. I personally would do the same thing. I think people need to get vaccinated as quickly and expeditiously as possible.” In a video release by the White House on Monday, Dr. Fauci explained the method used by the vaccine and attempted to settle fears that the J&J vaccine is less effective than the other COVID-19 vaccines available. On Saturday, the FDA issued an emergency use authorization for the Johnson & Johnson COVID-19 vaccine. Dr. Fauci sat down to answer your questions. pic.twitter.com/KJQ2SrVclp — President Biden (@POTUS) March 1, 2021 South Africa Removes ‘Remaining Restrictions on Economic Activity’ With COVID-19 cases – and its economy – in decline, South Africa has moved to a more relaxed COVID Alert Level 1 from Monday in the hope that this will stimulate economic activity. South African President Cyril Ramaphosa made the announcement on national television on Sunday night but stressed that the mandatory wearing of masks in public was even more important as the country opens up. The country’s curfew is now between midnight and 4am, alcohol sales are permitted over weekends and indoor gatherings of up to 100 people and outdoor gatherings of up to 250 people will be allowed, depending on the size of the venue. Five airports have been opened for international flights, although 33 land border posts will remain closed. Night clubs and night vigils are still not allowed. “The return to alert level 1 means that most of the remaining restrictions on economic activity have been removed. We expect this to lead to higher consumption spending, bolstered by the steady recovery in employment,” said Ramaphosa. The return to Alert Level 1 means that most of the remaining restrictions on economic activity have been removed. We expect this to lead to higher consumption spending, bolstered by the steady recovery in employment.https://t.co/YAc8A9h2Jt — Cyril Ramaphosa 🇿🇦 #StaySafe (@CyrilRamaphosa) February 28, 2021 By Sunday, 67,000 health workers had been vaccinated with the Johnson & Johnson vaccine in the 10 days since the vaccine had landed in the country. A new batch of 80,000 J&J vaccines arrived in the country on Saturday. Ramaphosa said that the number of vaccination sites “will increase from 17 to 49 sites next week. Of these, 32 will be in public hospitals, and 17 in private hospitals”. Ramaphosa also reported that a further 11million J&J vaccines had been secured along with 20 million Pfizer vaccine doses with delivery expected in the second quarter, as the country rushes to vaccinate health workers, frontline workers and the elderly before the southern hemisphere winter and an anticipated third wave of the pandemic. South Africa recorded around 10,000 new COVID-19 cases in the past week, a quarter of the case load it recorded a month ago. Image Credits: Johnson & Johnson, NBC News. 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. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.