Congratulations! We’ve made it through another challenging year. Though the global community continued to feel the pressure of managing the repercussions of COVID-19, several therapeutic breakthroughs have saved many lives and prevented more severe damage to health and societal infrastructure.
Here, we look back on the moments that defined the COVID-19 response in 2021 and ask industry experts how they expect 2022 to shape up.
Despite the first COVID-19 vaccines making their way to patients in 2020, the pipeline of innovation did not slow during 2021. Among other regulatory agencies, the FDA granted emergency use authorization to some newer products – helping to expand protection among global populations to varying degrees of success (see timeline).
But we are all aware that pharmaceutical R&D journeys do not always end in approval – far from it. Several therapies and treatments were not recommended – mainly because of a lack of efficacy. Among them was ivermectin – a drug first developed to treat parasitic worm infections. Flaws in the data provided in a preprint study casted doubt on how effective the treatment actually was. The results claimed that the drug could reduce COVID-19 mortality rates by 90 percent (1), but the same results led both regulatory and healthcare agencies to warn against its use (2). The controversial case also brought to light the increased pressures experienced by professionals within research settings and the challenges of conducting research under accelerated timelines.
Big pharma companies had their fair share of development challenges too. Novartis was forced to scrap its COVID-19 cell therapy, remestemcel-L, as there wasn’t substantial data to prove its efficacy. The move also meant that the company had to cut ties with its collaborative partner, Mesoblast (3).
Although AstraZeneca found success (and some controversy) with its viral vector vaccine, ChAdOx, the company failed to bring its antibody treatment to market. The cocktail treatment was found to have a success rate of 33 percent in symptomatic patients (4). Despite the setback, the company is still pursuing other COVID-19 treatments with several products in its pipeline.
Many other companies had R&D hiccups throughout the year, but there were also some successes – particularly in terms of ongoing vaccine rollouts.
04/02/2021 - FDA changes emergency use authorization parameters for convalescent plasma – narrowing its use to immunocompromised and hospitalized patients in the early stages of disease
26/02/2021 - EMA’s human medicines committee advises that REGN-COV2 (casirivimab and imdevimab) only be used in patients who don’t need supplemental oxygen treatment
05/03/2021 - FDA issues a warning against the use of ivermectin
05/03/2021 - EMA’s human medicines committee decides that a combination of antibody treatments, bamlanivimab and etesevimab, can be used to treat COViD-19 patients
11/03/2021 - EMA grants conditional marketing authorization to COVID-19 Vaccine Janssen
26/03/2021 - EMA’s human medicines committee decides that regdanvimab (CT-P59) can be used in adult patients who do not require supplemental oxygen
26/05/2021 - FDA approves Xevudy (sotrovimab/GSK4182136)
28/05/2021 - EMA’s human medicines committee recommends an extension of indication for Corminaty (BNT162b2), allowing children aged 12–15 to take the vaccine
24/01/2021 - FDA grants emergency use authorization for the use of Actemra (tocilizumab) in hospitalized patients
6/07/2021 - WHO recommends the use of IL-6 receptor blockers including Actemra (tocilizumab) and Kevzara (sarilumab)
29/07/2021 - FDA grants emergency use authorization for the use of baricitinib without remdesivir
18/10/2021 - EMA approves new ready-to-use Corminaty (BNT162b2) formulation
04/11/2021 - MHRA grants conditional marketing approval to Lagevrio (molnupiravir/MK 4482)
12/11/2021 - EMA approves Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab)
25/11/2021 - EMA’s human medicines committee recommends an extension of indication for Corminaty (BNT162b2), allowing children aged 5–11 to take the vaccine
07/12/2021 - WHO warns against the use of convalescent plasma
08/12/2021 - FDA grants emergency authorization to AstraZeneca's Evusheld (AZD7442)
16/12/2021 - EMA’s human medicines committee recommends authorization of Xevudy (sotrovimab)
16/12/2021 - EMA issues advice on the use of Paxlovid (PF-07321332 and ritonavir) to support the early use of the treatment in European countries
20/12/2021 - EMA grants conditional market authorization for the use of Nuvaxovid (NVX-CoV2373)
22/12/2021 - EMA approves Kineret (anakinra)
22/12/2021 - FDA approves Paxlovid (nirmatrelvir/ritonavir)
23/12/2021 - FDA grants emergency use authorization to Lagevrio (molnupiravir/MK 4482)
If you want the latest COVID-19 news, be sure to check out The Infectious Disease Curator – a weekly roundup of the research behind the industry’s progress.
Credit for pill photograph : Merck media library
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References
- FDA, “FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data.” (2021). Available at: https://bit.ly/3thDCHI.
- FDA, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” (2021). Available at: https://bit.ly/3GggH33.
- FDA, “Emergency Use Authorization 100.” (2021). Available at: https://bit.ly/3nfI462.
- FDA, “Emergency USe Authorization - Baricitinib.” (2021). Available at: https://bit.ly/34Er7f8.
- MHRA, “Regulatory approval of Lagevrio (molnupiravir).” (2021). Available at: https://bit.ly/3JZA6Yr.
- WHO, “WHO recommends against the use of convalescent plasma to treat COVID-19.” (2021). Available at: https://bit.ly/3JYMDLA.
- FDA, “Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals.” (2021). Available at: https://bit.ly/3tghgXd.
- FDA, “Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults.” (2021). Available at: https://bit.ly/33oe00J.
