Target Product Profile Analysis of COVID-19 Vaccines in Phase III Clinical Trials and Beyond: An Early 2021 Perspective

Abstract

The coronavirus SARS-CoV-2, which causes Coronavirus disease 2019 (COVID-19), has infected more than 100 million people globally and caused over 2.5 million deaths in just over one year since its discovery in Wuhan, China in December 2019. The pandemic has evoked widespread collateral damage to societies and economies, and has destabilized mental health and well-being. Early in 2020, unprecedented efforts went into the development of vaccines that generate effective antibodies to the SARS-CoV-2 virus. Teams developing twelve candidate vaccines, based on four platforms (messenger RNA, non-replicating viral vector, protein/virus-like particle, and inactivated virus) had initiated or announced the Phase III clinical trial stage by early November 2020, with several having received emergency use authorization in less than a year. Vaccine rollout has proceeded around the globe. Previously, we and others had proposed a target product profile (TPP) for ideal/optimal and acceptable/minimal COVID-19 vaccines. How well do these candidate vaccines stack up to a harmonized TPP? Here, we perform a comparative analysis in several categories of these candidate vaccines based on the latest available trial data and highlight the early successes as well as the hurdles and barriers yet to be overcome for ending the global COVID-19 pandemic.

A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial

“…It is being studied for the protection of naïve individuals, COVID-19 convalescent subjects ( https://rpcec.sld.cu/en/trials/RPCEC00000349-En and this paper) and its use as a booster for persons already immunized with other vaccines is being considered. It is safe: despite evaluating COVID-19 convalescents (including some with chronic disease, instead of healthy volunteers—as usual in clinical trials) we found fewer vaccine-associated adverse events than those reported in other studies [19] , [20] , [21] , [22] , [23] .…”

“…COVID-19 vaccines are being designed using several platforms; mRNA vaccines and viral vector vaccines are very immunogenic; there is concern regarding their reactogenicity [ 12 , 19 , 20 ]. Inactivated SARS-CoV-2 vaccines are less immunogenic; some reactogenicity has been reported [ 12 , 21 ].…”

Evaluation of Side Effects Associated with COVID-19 Vaccines in Saudi Arabia

“…For example, in Menni et al study the mean age of the participants was 50 years, and the majority of them were older than 55 years, where they reported less frequency of tiredness, from 8% to 21% of the participants, and women experienced more side effects than men [ 17 ]. It’s known that individuals who were vaccinated with the Oxford-AstraZeneca vaccine are more likely to have systemic side effects, such as fatigue and fever, compared to those who received Pfizer-BioNTech vaccine [ 20 ]. In our study, we found that the participants who received the Oxford-AstraZeneca vaccine reported a significantly higher frequency of fatigue and headache than those who received the Pfizer-BioNTech vaccine ( Table 4 ).…”

Variants of Concern Are Overrepresented Among Postvaccination Breakthrough Infections of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Washington State

“…Most of these vaccines use a recombinant spike protein derived from the first sequenced (Wuhan) strain from January 2020. The most widely used vaccines (mRNA-based mRNA-1273 and BNT162b2) have shown up to 95% efficacy at preventing clinical cases and up to 100% efficacy in preventing severe disease [ 1 ]. However, there is growing concern that emerging variants may escape vaccine-induced immunity and result in breakthrough infections in fully vaccinated individuals [ 2 ].…”