19 March 2021
In our latest series on COVID-19, Lionbridge experts offer perspectives on the ecosystem of clinical development and regulatory approvals during the pandemic and in the future.
With our scale, service excellence and suite of language, communication and technology solutions, Lionbridge is well positioned to support any accelerated efforts in bringing vaccines and lifesaving therapies to market.
The statistics in this article were updated on Thursday, March 4, 2020.
The Race for a COVID-19 Vaccine
You would have needed running shoes keep up with progress towards vaccines for the COVID-19 virus. The development of vaccine candidates has been happening with unprecedented speed, which makes the standard runway for developing new treatments look like a walk in the park. This race has a rising human toll at its heels and requires action from all stakeholders in the global healthcare infrastructure. The pandemic has now resulted in over 2.5 million deaths and 115 million confirmed cases, according to the WHO[i].
On November 25, 2020 Moderna[ii] announced that the European Commission approved an advance purchase agreement for 80 million doses of their mRNA-1273 vaccine candidate. On December 11, Pfizer and BioNTech broke the news[iii] that the FDA granted an Emergency Use Authorization (EUA) for their vaccine candidate BNT162b2. On March 5, 2021, Canadian regulators approved the Johnson & Johnson vaccine that, in addition to the AstraZeneca vaccine, brings the country’s approved vaccines to four. In all, at least seven different vaccines[iv] have been rolled out around the globe.
And these approvals are assuredly not an ending point for research on vaccine and treatment. As of early March this year, there were 1,334[v] trials in the global clinical pipeline addressing the SARS-CoV infection and at least 200[vi] vaccines in development.
Improving Speed and Maintaining Quality
A sense of urgency and radical change are usually the most powerful response mechanisms to combat an emergent threat and certainly this pandemic is no different. Operational excellence and virtual trial conduct were instrumental in the development of new COVID-19 vaccines, and the urgency and severity of the pandemic did not allow compromise on quality.
Regulatory authorities around the globe have been offering accelerated pathways for scientific advice and emergency use authorization. At the same time, they have emphasized that the investigational data must be sufficient in both quantity and quality to obtain a regulatory green light.
The FDA’s October guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19[vii] addressed the quality question head on. An EUA is only issued if the agency determines that “the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 trial that demonstrates the vaccine’s efficacy and safety in a clear and compelling manner.”
A constant balance between safety, efficacy and quality
In the clinical pipeline[viii] for COVID-19 vaccines, we’ve seen extensive phase 3 trials recruiting up to 40,000 participants across hundreds of sites and initiating with impressive speed. Pfizer’s phase 2/3 safety and efficacy trial for their vaccine candidate (BNT162b2) was initiated only three months after the initiation of their phase 1/2 safety and immunogenicity trials. And only two hours after the FDA greenlight, Pfizer administered the first vaccine dose to the first trial participant.
In Russia, as of March 4[ix], three vaccines had been approved. However, the first two were approved by the Russian Ministry of Health before entering phase 3. The August announcement from Vladimir Putin was received with great concern among vaccine experts[x] who have called this regulatory acceleration “beyond stupid," as well as “really scary and really risky.”
The development of medicines is a constant balance between safety, efficacy and quality and the race for a vaccine is one where speed must go hand-in-hand with data integrity and reliability.
From Competition to Collaboration: A Race Against Time
During the pandemic, industry players that normally compete on time-to-market for new innovative therapies have shown an unusual collaboration effort. Proprietary technologies and expertise (normally heavily guarded inside the pharma enterprise) are being shared to fast-track COVID-19 vaccines and treatments.
One such partnership[xi] is the collaboration between GSK and Sanofi, two of the world’s largest vaccine manufacturers and long-term rivals. GSK granted Sanofi access to its adjuvant technology which, in combination with Sanofi’s vaccine candidate, can enhance the immune response and reduce the necessary quantity of vaccine per dose. This enhancement will be critical given the extent of the pandemic and the partners’ commitment to the U.S. government to supply up to 100 million doses.
Sanofi itself has offered to support production[xii] of the Pfizer and BioNTech vaccine by allowing BioNTech to access part of their European infrastructure. And recently, Merck reached an agreement[xiii] with Johnson & Johnson agreed to help produce their vaccine.
07 May 2021
07 May 2021
06 May 2021
06 May 2021