COVID-19: Pathway to a vaccine
About the author:
- Author name:
- By Dr Derek Jellinek
- Job title:
- Senior Analyst
- Date posted:
- 23 July 2020, 2:50 PM
- Sectors Covered:
Executives from five drug companies leading the COVID-19 vaccine race (ie AstraZeneca (LON; AZN), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), Moderna (NASDAQ: MRNA), and Pfizer (NYSE: PFE)) appeared in front of the US House Energy and Commerce Oversight and Investigations Subcommittee to talk about their progress in developing a product the entire world desperately needs.
The hearing, entitled "Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine", comes as some public health officials have raised concerns about the rapid pace that some of these vaccines are being developed and whether long-standing safety and effectiveness standards are still being followed.
People weary of the constraints COVID-19 is placing on lives are pinning a lot of hopes on the promises those companies have made, particularly when it comes to when a vaccine might be ready.
But there are still looming questions, from who will get a successful vaccine first to how much it might cost. We highlight the most pressing questions below:
One or two doses?
- Pfizer – anticipates that the vaccine the company is taking to a pivotal trial "will use an initial dose plus a booster -- so two doses”.
- AstraZeneca – "our data suggest two doses give a stronger immune response than one, but until we understand the correlates of immune detection, we don't know whether one will be enough".
- Merck- has "selected vaccine candidates we hope will be single-dose."
Short development timeframe…a cause for concern?
- Chairman of the full Energy & Commerce Committee – "My fear is that FDA will be forced by the Trump administration to approve a vaccine that lacks effectiveness."
- AstraZeneca – "All of our interactions with the regulators have given us no evidence that they're lowering the standards or thinking about lowering the standards."
- Moderna – "We do believe it's going to be possible in a safe way to bring forth an effective vaccine in 12-18 months… we've been working around the clock ... to make sure we're doing this in an incredibly responsible way all the way through."
Who is furthest along?
- AstraZeneca – has already started a Phase 3 that will enrol more than 30,000 volunteers.
- Pfizer – is hoping to start a Phase 3 trial this month; "we hope to be able to provide a dossier of clinical data to the FDA in October"; the company hopes to deliver up to 100m doses globally in 2020 and 1.3bn doses in 2021.
- Moderna – Phase 3 trial "is a little beyond our control in terms of timing…we hope in the fall or towards the end of the year we would have data we can submit to the FDA".
- JNJ – "is targeting to at least have results by early 2021 and have 100m doses by the end of March”.
- Merck – "expects to be in clinical trials imminently but wouldn't expect to have a licensed product until 2021 at the earliest."
When will a vaccine be available?
- All companies except for Merck, endorsed the White House’s ambitious goal of having at least one widely available vaccine by the northern hemisphere’s winter.
- Merck – “has a long experience, and science is a stern taskmaster in this regard…there is a lot we don’t know about this virus.”
What’s the price?
- Rep. Jan Schakowsky (D-Ill) – said she was concerned about how expensive the vaccine would be and asked whether companies would agree to sell the vaccine at cost.
- Moderna – would not do so.
- Merck – promised eventual pricing would be transparent but said it was too soon to make a specific commitment.
- AstraZeneca – has an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to produce 300m doses of a vaccine, it will be selling the vaccine to the government "at no profit."
- JNJ – will be providing its vaccine at a "not-for-profit price" during the pandemic.
- Pfizer – said it recognises that "these are extraordinary times and our pricing will reflect that during the term of the pandemic; we'll price our potential vaccine consistent with the urgent global health emergency that we're facing”.
How will the vaccine be distributed?
- Committee members wanted to know the plans for how to prioritise who would receive the vaccine first
- All companies deferred to the federal government, which would handle distribution.
- Rep. Raul Ruiz, MD (D-Calif.) said "We should be able to develop a distribution plan based on public health principles to slow transmission."
- Rep. Joe Kennedy (D- Mass) urged the companies to develop their own distribution plans and warned that relying on an administration that has struggled to provide testing and protective equipment could backfire… “Buyer beware on this.”
- Shortly after the hearing ended, the National Academy of Medicine announced that it was launching a committee to study the equitable allocation of any COVID-19 vaccine developed.
Where are the vaccine made and raw materials sourced?
- Rep. Buddy Carter (R-Ga.) – "This is a serious issue…I think we should do everything we can to domesticate manufacturing."
- AstraZeneca – all "comes from the US."
- Merck – "Is generally very much localised to the US and a couple of places in EU, but I need to verify the entirety of the supply chain."
- Moderna – is "made entirely in the US" but some supplies for the vaccine's raw materials are being procured internationally, mostly from EU."
How to overcome vaccine hesitancy?
- JNJ – "Efforts need to start now in terms of education and outreach."
- Pfizer – "Data transparency is really important."
More COVID-19 insights
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