Below we round up the latest news on efforts to combat the Covid-19 epidemic.
- New research on AstraZeneca and Oxford University's Covid-19 vaccine candidate suggests its safe, about 62% effective in preventing Covid-19 among patients who received two standard doses of the vaccine. The findings also showed that, when one group of trial participants were given a half dose of the vaccine followed by a full dose, vaccine efficacy was 90%, though experts are unsure why that happened, Axios reports. The researchers found overall vaccine efficacy was about 70% across both groups (Marchione, Associated Press, 12/8; Baker, Axios, 12/8; Branswell/Herper, STAT News, 12/8).
- FDA on Friday issued an emergency use authorization for an at-home diagnostic test used to detect both Covid-19 and the flu, making it the first test of its kind to receive such authorization. The test, developed by Quest Diagnostics, can be used by patients with a prescription who are presenting with symptoms of either Covid-19 or influenza A or B. The sample is collected by the patient at home and sent to a Quest laboratory for analysis (GenomeWeb/Modern Healthcare, 12/7).
- IBM's cybersecurity division has discovered a series of cyberattacks aimed at companies and government organizations in charge of distributing Covid-19 vaccines. According to researchers at IBM and the Department of Homeland Security, the attacks appear to be designed to steal login information from corporate executives and organization officials involved in the vaccine refrigeration process. IBM said it's not yet clear whether the attacks aim to steal technology for vaccine refrigeration or to sabotage vaccine transportation. People familiar with the matter told the Wall Street Journal that the cyberattacks, which originated in North Korea, have targeted at least six pharmaceutical companies in the United States, United Kingdom, and South Korea. The companies targeted include Johnson & Johnson and Novavax in the United States; AstraZeneca in the United Kingdom; and Genexine, Shin Poong Pharmaceutical Co., and Celltrion Inc. in South Korea. Pfizer and BioNTech also announced that data on their Covid-19 vaccine candidate was "unlawfully accessed" during a cyberattack on the European Medicines Agency (EMA). EMA declined to provide more details on the attack (Zaboeva/Frydrych, Security Intelligence, 12/3; Sanger/LaFraniere, New York Times, 12/7; Jeong, Wall Street Journal, 12/2; Associated Press, 12/9).
- Johnson & Johnson has announced it is cutting down the size of its Covid-19 vaccine trial from 60,000 participants to 40,000 in response to how widespread the disease is in the United States. Since the disease is so widespread, the company said that researchers should be able to draw conclusions on the vaccine with a smaller trial, as people are more likely to be exposed to the new coronavirus than before. In a statement, the company said an application for FDA's emergency use authorization could be submitted in February, if the vaccine proves to be safe and effective (Herper, STAT News, 12/9).
- The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom on Wednesday said people with "history of a significant allergic reaction" should not receive Pfizer and BioNTech's Covid-19 vaccine. Two people who were given the vaccine in Britain on Tuesday—and who both typically carry adrenaline shots for allergies—had allergic reactions to the vaccine. Moncef Slaoui, co-head of Operation Warp Speed, said that trials in the United States haven't had significant problems with allergic reactions but that they have also kept out participants with a history of severe allergic reactions. Slaoui said FDA will discuss the development and advised that people with severe allergies "should not take the vaccine until we know exactly what happened" (Collis, Politico, 12/9; Weintraub, USA Today, 12/9).
- The National Health Service in Britain has administered the first shots of Pfizer and BioNTech's Covid-19 vaccine, with the inaugural shot going to 90-year-old Margaret Keenan. Fifty hospitals in Britain will be administering the vaccine until NHS is able to deliver the doses to nursing homes and doctor's offices. Britain has said doctors, nurses, certain people over the age of 80, and nursing home workers will be the first to get the vaccine. Meanwhile, Canada on Wednesday approved Pfizer and BioNTech's Covid-19 vaccine, which means Canadians may be able to get the vaccine as soon as next Wednesday, according to Maj. Gen. Dany Fortin, who is overseeing Canada's distribution of the vaccine (New York Times, 12/9; Booth/Adam, Washington Post, 12/8; New York Times, 12/10).
- Officials with the World Health Organization (WHO) last week warned that recent data suggests reinfection of the new coronavirus can occur, though it is rare. Continuing research suggests that immunity to the new coronavirus may last for at least six months, according to Maria Van Kerkhove, head of WHO's emerging diseases and zoonosis unit. "In some people, it may wane after a few months, but we do get a good indication that natural infection immune response is lasting for some months," Van Kerkhove said. "We're about a year into this pandemic, and so we still have a lot to learn" (Higgins-Dunn/Lovelace, CNBC, 12/4).