Pandemic preparedness and response: beyond the Access to COVID-19 Tools Accelerator.

Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access to vaccines and therapeutics. Existing intellectual property (IP) regimens, trade secrets and data rights, under which pharmaceutical firms operate, have also posed obstacles to increasing manufacturing capacity, and ensuring adequate supply, affordable pricing, and equitable access to COVID-19 vaccines and other health products in low-income and middle- income countries. We propose: (1) Implementing alternative incentive and funding mechanisms to develop new scientific innovations to address infectious diseases with pandemic potential; (2) Voluntary and involuntary initiatives to overcome IP barriers including pooling IP, sharing data and vesting licences for resulting products in a globally agreed entity; (3) Transparent and accountable collective procurement to enable equitable distribution; (4) Investments in regionally distributed research and development (R&D) capacity and manufacturing, basic health systems to expand equitable access to essential health technologies, and non-discriminatory national distribution; (5) Commitment to strengthen national (and regional) initiatives in the areas of health system development, health research, drug and vaccine manufacturing and regulatory oversight and (6) Good governance of the pandemic prevention, preparedness and response accord. It is important to articulate principles for deals that include reasonable access conditions and transparency in negotiations. We argue for an equitable, transparent, accountable new global agreement to provide rewards for R&D but only on the condition that pharmaceutical companies share the IP rights necessary to produce and distribute them globally. Moreover, if countries commit to collective procurement and fair pricing of resulting products, we argue that we can greatly improve our ability to prepare for and respond to pandemic threats.

COVID-19 vaccine trials with children: ethics pointers.

As healthcare authorities around the world strive to get as many citizens as possible vaccinated against the SAR-CoV-2 virus, many countries have begun including children in the population groups to be vaccinated. Properly designed clinical trials involving children are important to ensure safety, efficacy, and dosage of therapies in (developing) children. Within the complex health, social, and political scenario of the ongoing pandemic, ethics committees and policy makers in low-income and middle-income settings need to consider additional ethical questions when called on to review phase III COVID-19 vaccine trials involving in children. We set out some of the ethical questions to keep in mind before, during, and after the implementation of phase III COVID-19 vaccine trials in limited resource settings. Specifically, we discuss and offer succinct answers to the following questions: How relevant will the trial vaccine be for the population participating in the trial? Should vaccines that have not been approved for use among adults be approved for use in trials with children? Which children should be involved in COVID-19 vaccine trials? What criteria of informed consent are to be adopted with minors? Placebo versus an existing already approved vaccine? What specific duties of ancillary care should be taken into consideration for COVID-19 vaccines especially in low-income and middle-income countries? The answers we offer are considerations that can serve as 'things to think about' when reviewing or implementing COVID-19 trials involving children in low-income settings.