Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation firstname.lastname@example.org
SPECIAL REPORT #32
Progress in COVID-19 Treatments
The month of November 2020 will undoubtedly remain a major milestone in the race engaged by the biopharmaceutical companies to find, develop and register treatments targeting the SARS-CoV-2 virus.
On November 9, Eli Lilly received a U.S. FDA emergency use authorization (EUA) for bamlavinimab (LY-CoV555), a neutralizing antibody, for the treatment of recently diagnosed COVID-19 patients. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalisation. On November 20, Eli Lilly received and interim authorization for bamlanivimab from Health Canada as a treatment for COVID-19.
On November 9, Pfizer and BioNTech announced that BNT162b, their investigational mRNA COVID vaccine, had an effectiveness of more than 90% and on November 20, Pfizer CEO Albert Bourla announced that his company had submitted a file to the U.S. FDA requesting an emergency use authorisation (EUA). BNT162b was finally shown to be 95% effective in the overall population and in 94% in the population aged over 65 years.
On November 16, Moderna announced that mRNA-1273, its COVID-19 vaccine candidate, met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study, with a statistical vaccine efficacy of 94.5%. On November 17, Moderna announced that the European Medicines Agency (EMA) began rolling review of mRNA-1273 based on preclinical, clinical and CMC data available at the given date.
On November 19, Eli Lilly announced that it had received an EUA from the U.S. FDA for the distribution and emergency use of baricitinib or OLUMIANT, an oral Janus Kinase Inhibitor (JAK), to be used in combination with remdesivir in hospitalized adult and paediatric patients with suspected or laboratory confirmed COVID-19, who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
On November 21, Regeneron announced that the U.S. FDA had issued an EUA for REGEN-COV-2 for the treatment of COVID-19 in high risk patients with mild to moderate disease. REGEN-COV2 is a cocktail of casirivimab and imdevimab, two human IgG1 human monoclonal antibodies, that target the receptor binding domain of the spike protein of SARS-CoV-2. The drug is not suited in patients who require oxygen therapy due to COVID-19.
Lilly and Regeneron stated that their approved EUA drugs will be immediately available through the U.S. government’s allocation program. “Regeneron now expects to have REGN-CoV-2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January and approximately 300,000 patients in total by the end of January 2021” the company stated on November 21.
On November 23, AstraZeneca and University of Oxford released an interim analysis on clinical results with ChAdOx-1 – their COVID-19 vaccine which uses a viral vector technology- showing efficacy ranges from 62% to 90% depending on dosage. One regimen (around 2,700 subjects) showed an effectiveness of 90% when given a half dose followed by a full dose. The other regimen (around 9,000 subjects) showed a 62% efficacy when given two full doses at one month interval. The combined analysis from both regimens came out with an average vaccine effectiveness of 70%. Although ChAdOx-1 seems to be less efficacious than the Pfizer/BioNTech and the Moderna vaccines , the AstraZeneca/Oxford University jab may have some distribution advantages as it just needs to be kept at refrigerator temperature and it may be promoted at a lower price than its American competitors.
“On the 11th or 12th of December, hopefully the first people will be immunized across the U.S., across all states, in all the areas where the state departments of health will have told us where to deliver the vaccines,” Moncef Slaoui, head of the Operation Warp Speed told CNN’s State of the Union on November 22. These news are highly welcome at a time where the U.S. approaches 200,000 new cases of COVId-19 per day and when the Thanksgiving family gatherings and celebrations might add an additional risk of the pandemic spreading.
On a less shiny side, on November 20, the World Health Organisation (WHO) issued a conditional recommendation, against the use of remedesivir, which had received U.S. FDA full approval in October, in hospitalized COVID-19 patients, regardless of disease severity. More specifically the panel of WHO experts found “no important effect on mortality, need for mechanical ventilation time to clinical improvement and other patient-important outcomes.”
Paris, November 23, 2020
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