• Reuters reports that monoclonal antibodies from Regeneron and Eli Lilly are ineffective against the Omicron variant, while Evusheld (AstraZeneca) showed promise and sotrovimab (GlaxoSmithKline/Vir) retains its efficacy against Omicron. Source
• AstraZeneca issues a press release to announce that an independent preclinical study from the US FDA’s Center for Biologics Evaluation and Research and funded by the US government, found that its monoclonal antibody, Evusheld, is effective against the Omicron variant. The company, and third-party laboratories, are conducting additional analyses to evaluate Evusheld against the Omicron variant, with data anticipated in the near future. Source
• Regeneron issues a press release to announce that REGEN-COV, its combination monoclonal antibody treatment for COVID-19, remains active against the Delta variant but has reduced potency against Omicron. The company is developing “next generation” monoclonal antibodies that are active against the Delta and Omicron variants, and plans to launch clinical trials in Q1, 2022. Source
• The US CDC recommends giving preference to coronavirus vaccines other than Johnson & Johnson’s due to increasing evidence that it can trigger a rare blood clotting disorder. The vaccine has been linked with dozens of cases and at least nine deaths in the US, with the highest risk among women ages 30 to 49, estimated at 1 in 100,000.
The J & J vaccine will remain available to people who are “unable or unwilling” to receive mRNA-based coronavirus vaccines from Moderna or Pfizer-BioNTech. Source
• The UK National Institute of Health Research Leicester Biomedical Research Centre assessed 2,230 adults who were hospitalised with COVID-19. All participants completed a five-month assessment; so far, 807 of them have completed both the five-month and 12-month assessments, which measured recovery based on patient-reported data, physical performance and organ function tests.
The researchers, who were from 53 institutions and 83 hospitals across the UK, found that less than 3 of 10 COVID-19 patients felt fully recovered a year after being discharged from the hospital. Their most common symptoms were fatigue, muscle pain, slowing down physically, poor sleep and breathlessness. They described a substantially worse health-related quality of life compared to pre-COVID.
Females, obese people and those who required invasive mechanical ventilation were least likely to make a full recovery from COVID-19. At five months post-hospitalization, people with very severe physical, mental and cognitive impairment had a higher number of persistent symptoms versus people with mild impairment, although there was little improvement in physical and mental health from the five-month to one-year assessments, regardless of disease severity.
Blood profiles revealed higher levels of substances associated with whole-body inflammation and molecules associated with tissue damage and repair in participants with very severe-Long COVID, versus mild cases. They also found a pattern of substances linked to poor cognition among people reporting slower thinking or ‘brain fog’, which suggests possible neuro-inflammation.
Professor Louise Wain, a lead author, said “The good news is that we have identified some differences in the blood samples of those who are still experiencing the long-term physical and cognitive effects of their COVID-19 hospital admission. These differences give us clues about the potential underlying mechanisms and suggest that we may be able to use existing medicines that target these mechanisms to help these subgroups of patients.” Source
• London’s Imperial College releases a report on the impact of coronavirus boosters against the Omicron variant, estimating that neutralizing antibody titres for Omicron are reduced by 4.5-fold compared to Delta, and that if the immunogenicity of a Pfizer/BioNTech booster dose wanes at the same rate as primary vaccination, protection against severe disease from Omicron could be reduced to 80 percent in two months. The authors underscored that booster doses will be critical for mitigating future waves of Omicron, noting that Omicron variant-specific vaccines are likely to be required. Source
• The US is facing a double threat from SARS-CoV-2, as the Delta variant continues to circulate amidst surges of Omicron, which accounted for 3 percent of virus that has been sequenced nationally over the last week. Source
• Associated Press reports that Afghanistan’s health care system is nearing collapse, as hospitals endure equipment and medicine shortages, and their staff goes unpaid. Some hospital workers have not been paid for months, and are selling their furniture to survive.
“Oxygen is a big issue for us because we can’t run the generators,” said Dr. Ahmad Fatah Habibyar, who manages logistics and the Afghan-Japan Hospital, the only facility in Kabul that treats COVID-19 patients, adding “…We can’t afford the diesel.”
Most donors are withholding finding from the country’s Taliban government. The country is also facing severe food shortages; according to the UN, 22 percent of Afghanistan’s 38 million people are near famine, and another 3 percent of them face acute food insecurity. “We’re seeing the economic collapse being exponential,” said Martin Griffiths, the UN Humanitarian Chief, “It’s getting more and more dire by the week.” Source
• As Omicron cases surge in Britain, France limits travel from the UK to French citizens or permanent residents carrying out essential work, or people who have been in transit for less than 24 hours. Travelers will need a negative SARS-CoV-2 PCR test result within 24 hours of departure, and must undergo seven days of self-isolation in France unless they can produce a negative test result after 48 hours in the country.
Travel to Britain from France has also been limited to British nationals returning home, people attending a funeral of a close relative, people traveling for medical reasons, people carrying out essential work, and some other exceptional cases – and truck drivers. Source
• Valneva issues a press release to announce data from its 77-person phase I/II booster trial of VLA2001, an experimental inactivated, adjuvanted coronavirus vaccine. Participants had been given two doses of the vaccine 7 to 8 months before receiving the booster dose. Among 45 of the 77 participants included in the analysis, antibody titers (against the original virus discovered in Wuhan) increased by 42- to 106-fold over a pre-booster levels – four-fold higher than after primary vaccination; the company will assess efficacy against Omicron and other variants of concern. Source
• After AT-527, Atea’s experimental SARS-CoV-2 antiviral, was ineffective in a phase II trial – and Roche backed out of a $350 million development deal – Atea is closing the phase III trial and initiating a 200-person, phase II trial of AT-527 for unvaccinated patients with moderate COVID-19 at high risk for severe illness. Source
• The EMA’a Human Medicines Committee issues a press release to announce that it has recommended authorizing strovimab, a monoclonal antibody for treating COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen and are at increased risk of severe COVID-19. Source
• EMA’s Human Medicines Committee issues advice on the use of the ritonavir-boosted protease inhibitor paxlovid for treating COVID-19. Although it is not yet authorised in the EU, paxlovid can be used to treat adults with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe given within five days of symptom onset.
The EMA began a rolling review of paxlovid data on 13 December 2021, ahead of a possible application for marketing authorization. Source
• A shortage has led Germany to ration coronavirus vaccines during its booster campaign. Using $2.5 billion, which the German parliament’s budget committee has approved for 92 million additional vaccine doses, the country’s health minister is seeking to purchase unused doses from Eastern European countries and buy more shots from vaccine producers. Source
• In Thailand, where 61 percent of the country’s 72 million residents have been fully vaccinated, 4.4 million booster doses have already been administered. The nation is expected to meet its target of 100 million vaccine doses before the end of 2021. “At the current pace of vaccinations, the country should reach 90 percent coverage by March,” said Somprawin Manprasert, chief economist at the Bank of Ayudhya’ research unit. Source