Physician Views: COVID-19 vaccines – is an end to the pandemic in sight?

Pfizer and BioNTech said on Friday that they have submitted a request to the FDA seeking emergency-use authorisation for their COVID-19 vaccine BNT162b2, with rolling regulatory submissions ongoing in other key markets.

Confirmation of this request, which could see the vaccine become available for non-clinical trial participants by mid-December, part bookends another breakthrough week for COVID-19 vaccine development.

On Monday, Moderna unveiled striking efficacy for its vaccine mRNA-1273 based on data from a first interim analysis and on Wednesday Pfizer and BioNTech released equally impressive results from the primary analysis of their US Phase III study of BNT162b2.

With the effectiveness of both these vaccine candidates – at around 95% – better than had been widely anticipated, there is now significant hope that the COVID-19 pandemic can be significantly slowed and ultimately ended by this first-generation of vaccines within the next 12 months.

To assess the impact of these latest data for BNT162b2 and mRNA-1273 further, we are running a short survey to infectious disease specialists and will publish the results later this week. Specifically, we are asking them…

Recent updates show that the first two COVID-19 vaccine candidates (BNT162b2 and mRNA-1273) are approximately 95% effective, including evidence of similar efficacy in older patients (aged 60 and upwards). In the case of BNT162b2, 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group. For mRNA-1273, an interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group.

Based on these data, how confident are you that first-generation vaccines will bring an end to the COVID-19 pandemic?

1 – Not confident            2            3            4            5 – Extremely confident

_________

Primary efficacy analysis of the study evaluating BNT162b2 also identified 10 severe cases of COVID-19, nine of which occurred in the placebo group and one in the BNT162b2 vaccinated group.

In the first interim analysis of data for mRNA-1273, 11 severe cases were identified, all of which occurred in the placebo group and none in the mRNA-1273 vaccinated group.

How compelling do you consider these findings?

1 – Not compelling         2            3            4            5 – Extremely compelling

_________

Data demonstrate that one of the vaccines (BNT162b2) was well tolerated with over 43,000 participants enrolled and no serious safety concerns observed. The only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2%. Consistent with earlier results, older adults tended to report fewer and milder adverse events following vaccination.

In the first interim analysis of data for mRNA-1273, a review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2%). These solicited adverse events were generally short-lived.

How satisfied are you with the known safety profiles of these two vaccines?

1 – Not satisfied              2            3            4            5 – Extremely satisfied

_________

How confident are you that more serious and/or long term side-effects with these vaccines will not emerge?

1 – Not confident at all  2            3            4            5 – Extremely confident

These data appear to have set a benchmark – of around 95% - for vaccine effectiveness. Would you be willing to use a less effective COVID-19 vaccine (with a similar side-effect profile) if your access to the most effective vaccines was limited, and if so what is the lowest rate of effectiveness (below 95%) you would consider using?

No

Yes – __%

How confident are you that the durability of COVID-19 vaccines will be long enough to be practical? (i.e. minimum requirement of annual vaccination)

1 – Not confident at all  2            3            4            5 – Extremely confident

_______________

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here

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