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The COVID-19 pandemic has completely upended the way clinical trials are conducted across the world. In fact, the Pfizer/BioNTech and Moderna vaccines were both manufactured in record time and the first successful mRNA vaccines ever developed.
Vaccine development has also been done at unprecedented speed, considering the time between when the genome of the novel coronavirus was sequenced to the date the first person received the authorized Pfizer/BioNTech mRNA vaccine was just 332 days. In fact, Pfizer/BioNTech and Moderna vaccines were not only manufactured in record time, but the first two mRNA vaccines successfully developed for any disease.
As of March 2021, more than 319 million people around the world have had at least one vaccination against the virus, which is a medical miracle in its own. Heading into the next phase of mitigation, vaccine makers will need to build on the learnings from the past year as we close in on herd immunity, where an estimated 70-90% of the global population is immunized.
Tackling the variants
In the U.S. in particular, the FDA has given emergency use authorization (EUA) to at least three vaccines makers in just the past year, including Moderna, Pfizer/BioNTech and Johnson & Johnson, with more in the pipeline like Novavax, which recently reported a 96% efficacy rate against the original coronavirus in U.K. trials, and AstraZeneca.
As we come into the second phase of the pandemic and closer to herd immunity, clinical trials will pivot to developing new vaccines or updating existing ones for the regional variants, such as those emanating from the U.K., Brazil and South Africa. The South African variant (B.1.351) in particular has proved formidable against current vaccines. Based on recent data, Moderna showed a six-fold reduction in antibody development while AstraZeneca’s clinical trial revealed only 10% efficacy. Studies to determine the efficacy of new variant-specific vaccines and booster shots against this strain are continuing to ramp up.
With more variants bound to emerge, room will be made for new players to either partner with current vaccine players, such as the collaboration between Merck and Johnson & Johnson on manufacturing and distribution – or develop their own vaccines or therapeutics as countries fight the last stretch toward herd immunity.
To ensure vaccines are distributed equitably and ethically, countries must avoid nationalistic behaviors and work with developing nations on providing access. Public-private partnerships will play a huge role in scaling up across global populations. In March, UNICEF partnered with the government of Kenya and COVAX, a vaccine distribution initiative co-led by the World Health Organization (WHO), to deliver over 1 million doses of the AstraZeneca vaccine to the country’s citizens, as one such example. COVAX plans to distribute 1.2 billion doses to developing countries by the end of 2021.
COVID-19 vaccine development is beginning to reach critical mass and Informa Pharma Intelligence’s Citeline platform has closely followed every movement. As of April 1, 2021, Citeline has accounted for over 1,000 drugs in development and over 4,500 clinical trials to treat or prevent COVID-19. Citeline has also tracked 267 prophylactic vaccines in active development by the industry, 67 of which are in clinical trials — and a total of 396 prophylactic vaccine trials, of which 159 are ongoing and a further 169 are planned.
Diversity in clinical trial recruitment
In addition to speed and flexibility, there has been a huge increase in scrutiny around diversity in clinical trial recruitment during the pandemic. It is well known that COVID-19 has disproportionately impacted Black, Hispanic and indigenous communities, the elderly and those with pre-existing conditions.
Future clinical trials will need to continue meeting diversity goals for trial recruitment, requiring them to include participants from communities that are disproportionately impacted by the virus. Because those same communities have been historically underrepresented in clinical trials, it will be vital to fill enrollment gaps not only to ensure efficacy but also to build trust with diverse groups that will be taking the vaccines.
In the fall of 2020, Informa Pharma Intelligence’s TrialScope Connect (now Citeline Connect) partnered with a leading pharmaceutical company during the Phase III study of its COVID-19 vaccine to fulfill its diversity and inclusion commitment of more than 11,000 participants from communities of color, reflecting U.S. demographics. Citeline Connect provided the company with real-time metrics, leveraging its collective of over 75 different recruitment partners to refer patients to research sites simultaneously, while nimbly rerouting new referrals to ease congestion.
Transparency and targeted communication
Trust in healthcare professionals and public health officials is essential for successful vaccine uptake. Informa Pharma Intelligence’s Pulse Report in October revealed that over 1 in 4 Americans said they would be more likely to take the vaccine if they had more information on clinical trials.
As different vaccines distribute amongst the population, patients will need clear and accurate clinical trial data regarding the dose they’re receiving, as well as those who participated in the clinical trial – and healthcare professionals will be critical in delivering that information, in addition to public posting of study results and protocols.
In order to reach herd immunity, it will also require rigorous accountability and transparency on behalf of vaccine makers communicating their clinical trial data to raise trust levels and encourage patients, particularly in the most vulnerable communities, to take the vaccine.
The pandemic has already marginally improved public perception of pharmaceutical companies over the past year with increased visibility into clinical trials – a sign that more transparency will be central to gaining public trust. That said, we’ve seen what can impact public trust when vaccine makers publish misleading clinical trial data, as in the case of AstraZeneca potentially releasing outdated information from its Phase III U.S. trial and the ensuing controversy.
In February, Informa Pharma Intelligence’s Skipta partnered with the Ad Council and COVID Collaborative’s national COVID-19 vaccine education effort by donating educational media geared toward healthcare professionals. Featuring public health officials like Dr. Anthony Fauci and other vaccine experts, this effort constituted one of the largest public education campaigns in history, combatting misinformation surrounding the vaccine using targeted communication strategies for diverse audiences.
The battle against COVID-19 is ongoing, but unprecedented leaps have been made in the clinical trial process to develop several successful vaccines at breakneck speed under intense scrutiny from the public. Vaccine makers must continue developing new or updating existing vaccines to tackle emerging variants, reaching goals tied to diversity in clinical trial recruitment, and communicating transparently around clinical trial data, especially to more vulnerable groups.
As prior learnings are built upon, we are able to move further in toward mitigation and may reach herd immunity sooner than we think.
Citeline product suite has all the tools necessary to help inform clinical trial programs. To learn more or request a demo, visit here.
Citeline’s Skipta platform is the leading social network of specialized online medical communities for verified healthcare professionals. To learn more or request a demo, visit here.
Sponsored by Citeline
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