i-Base

HTB: no. 13/14 – HIV and COVID-19: issue 10 (9 December 2020)

This last issue of HTB for 2020 just catches news of the first approvals for the Pfizer/BioNTech vaccine against COVID-19 (BNT162b2) – in the UK, then Bahrain, Canada and now in the US.

The results – available in detail in the 50-odd page FDA briefing document and also just published in the NEJM – were far better than experts hoped for, even while we still need further data on the duration of protection (against COVID-19) and whether there is even efficacy against transmission (of SARS-CoV-2). [1, 2]

The FDA hearing for the Moderna/NIH vaccine – also using mRNA – is due on 17 December with approval also expected. [3] Although more difficult to interpret, this issue of HTB includes results from the Oxford/Astra-Zeneca ChAdOx.1 vaccine just published in the Lancet (where transmission is at least a secondary endpoint in the UK study).

Reports will now increasingly move to vaccine manufacturing, delivery and equity of access. So although vaccinations have already started in the UK – and this issue includes BHIVA guidance for people living with HIV – universal access globally might still take several years – showing the continued importance of also finding effective treatment.

We unfortunately report disappointing news from the WHO SOLIDARITY study that found no impact on mortality from any of the four treatments and the Barcelona PEP study showing no impact of hydroxychloroquine (HCQ) as PEP before infection is established (confirming other studies). This questions the likelihood of any benefit in mild infection even though both HCQ and lopinavir/r are the two treatments currently proposed for a new 13-country study in Africa.

HIV news is still just as important. This issue includes reports on approvals and essential access to new paediatric formulations of dolutegravir – these developments are some of the rare good news stories from 2020.

Reports from HIV virtual conferences are also included – and these will be expanded in the next issue as those meetings enable open access to their talks and presentations.

And finally, this double issue of HTB includes a short supplement on events from World AIDS Day 2020.

We produced a short compilation of projects from 1 December this year, so that as we move forward into what will hopefully be an easier and safer 2021 we also remember the people whose memory keeps us focused on a better New Year ahead.

As always, we would like to thank our readers and supporters and wish you best seasons greetings for a safe and happy 2021.

References

  1. FDA briefing. Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020.
    https://www.fda.gov/media/144245/download
  2. Polack FP et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. NEJM DOI: 10.1056/NEJMoa2034577. 10 December 2020).
    https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
  3. Vaccines and related biological products advisory committee: December 17, 2020 meeting announcement.
    https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement#event-information