SARS-CoV-2 Vaccine Developers Sign Safety Pledge

Since the announcement of Operation Warp Speed, the US SARS-CoV-2 vaccine acceleration program, there has been debate about the timeline for a vaccine.

Scientists are weighing the public health impact of rushing a vaccine to market, and potential safety issues, against the public health impact of delaying the added tool of vaccine immunity.

Some argue that the loss of scientific legitimacy from a rushed vaccine, particularly if there are safety concerns, could further fray trust between the public and public health.

Tuesday morning, added to the debate was a letter by 9 prominent pharmaceutical firms involved in the vaccine development effort. The letter’s signatories pledged to “continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.”

The letter features the following bullet points which outline the key principles behind making the declaration:

• Always make the safety and well-being of vaccinated individuals our top priority.
• Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
• Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
• Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

The pledge is intended to “help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” authors wrote.

The signatories were:

AstraZeneca

The firm has entered a phase 3 trial for its COVID-19 vaccine candidate, AZD1222, in the United States, as of September 1.

Trial centers across the US are recruiting up to 30000 adults. Prospective participants must be at least 18 years or over, can be from diverse racial, ethnic, and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.

Outside the US, the criteria for medical centers to be included are based on predicted transmission rates of the virus. Centers in Peru and Chile will be starting recruitment soon.

BioNTech + Pfizer

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

GlaxoSmithKline + Sanofi

Aiming for a long-term strategy with regulatory approval in 2021.

The collaboration’s Covid-19 vaccine is entering a 440-patient Phase 1/2 clinical trial in the U.S. Results are expected in December.

Johnson & Johnson

Johnson & Johnson announced that it has reached an agreement with the US Biomedical Advanced Research and Development Authority (BARDA) for the large scale manufacturing and delivery of 100 million doses of Ad26.COV2.S, an adenovirus based investigational vaccine.

Merck

According to the company, 2021 is the earliest it expects to have a vaccine ready.

Merck representatives have cast doubts on firms that have made earlier promises.

Moderna

Interim data from the phase 1 assessment of SARS-CoV-2 vaccine candidate mRNA-1273 showed the two-dose vaccine has tolerance across age groups and capability in inducing neutralizing antibodies in the upper-half range of convalescent serum across observed age strata.

Novavax

The firm reports promising data from its phase 1/2 randomized, observer-blinded, placebo-controlled trial. The investigational vaccine was delivered using its saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.