By Teodoro B. Padilla
The strength of pharmaceutical research and development, and unprecedented global collaborations are leading to the fastest rollout of vaccines in history.
Through the COVID-19 Vaccines Global Access (COVAX) facility, the global effort to securing a coronavirus disease 2019 (COVID-19) vaccine in a manner that is effective and fair, has been set in motion. We, in the research-based pharmaceutical industry, fully support COVAX and its objectives. Beyond developing safe and effective COVID-19 vaccines, we are scaling up manufacturing to ensure equitable access to people around the world.
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the body representing the innovative biopharmaceutical industry, outlined the key milestones leading to the commitment to rollout two billion doses of vaccines to lower-middle-income countries through COVAX.
Let’s remember the events of 2020: On Jan. 10, SARS-CoV-2 sequence data was shared through the Global Initiative on Sharing Avian Influenza Data (GISAID) Initiative. On March 11, the World Health Organization (WHO) declared COVID-19 a pandemic. Just eight days later, the research-based global pharmaceutical industry made a commitment to address COVID-19.
We leveraged our expertise and know-how to speed up the development of safe and effective vaccines to prevent COVID-19 in collaboration with others. Vaccine makers used their wide scientific insights from decades of working in developing medicines, vaccines, and diagnostics for infectious diseases such as MERS (Middle East respiratory syndrome), SARS (severe acute respiratory syndrome), Ebola, and influenza while closely working with regulators. In April, the first human clinical trial for a COVID-19 vaccine was conducted. On April 24, the IFPMA joined the Access to COVID-19 Tools (ACT) Accelerator, which led COVAX.
COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), WHO, and the GAVI Vaccines Alliance alongside key delivery partner UNICEF. The COVAX facility aims to provide doses for at least 20% of countries’ populations.
On Sept. 8, nine vaccine makers made a pledge, outlining a united commitment to rigorous scientific and regulatory processes, complying with strict requirements to develop safe and effective vaccines. On Dec. 31, the Pfizer/ BioNTech vaccine received WHO Emergency Use Listing.
This brings us to 2021, with the listing of AstraZeneca/Oxford University vaccine on Feb. 15.
During the first quarter of the year, COVAX with UNICEF will begin with the full-year rollout of two billion doses to protect high-risk and vulnerable people and frontline healthcare workers as priorities.
As of Feb. 16, the WHO reported 69 candidate vaccines in clinical evaluation and 181 candidate vaccines in preclinical evaluation. In late January, Johnson & Johnson announced that its single-shot vaccine met primary endpoints in an interim analysis of its Phase 3 trial.
COVID-19 vaccines are designed to help our bodies develop immunity to the coronavirus that causes COVID-19 without us getting the infection. Different types of COVID-19 vaccines work in different ways to offer protection. But with all types of vaccines, inoculation with a COVID-19 vaccine provides the body with a supply of “memory cells” that will remember how to fight the novel coronavirus in the future, the Centers for Disease Control and Prevention explained. GAVI and an article in the Healthcare IT News gave an overview of the four main types of COVID-19 vaccines that are already developed or are still in development. These four main types are:
Whole virus vaccines use a weakened or deactivated form of the novel coronavirus to trigger protective immunity to it. Live attenuated vaccines use a weakened form of the virus that can still replicate without causing illness. Inactivated vaccines use viruses whose genetic material has been destroyed so they cannot replicate, but can still trigger an immune response. Both types use well-established technology and pathways for regulatory approval.
Nucleic acid vaccines use genetic material — either RNA or DNA — to provide cells with the instructions to make the viral spike protein of the novel coronavirus. Once this genetic material gets into human cells, it uses our cells’ protein factories to make the antigen that will trigger an immune response. Since the antigen is produced inside our own cells and in large quantities, the immune reaction should be strong.
Viral vector vaccines, like nucleic acid vaccines, work by giving cells genetic instructions to produce antigens. However, a key difference is that this type of vaccine uses a harmless virus, different from the one the vaccine is targeting, to deliver these instructions into the cell. One type of virus that has often been used as a vector is adenovirus, which causes the common cold. As with nucleic acid vaccines, our own cellular machinery is hijacked to produce the antigen from those instructions, in order to trigger an immune response.
Protein subunit vaccines use pieces of the pathogen — often fragments of protein — to trigger an immune response. Doing so minimizes the risk of side effects, but it also means the immune response may be weaker. This is why protein subunit vaccines often require adjuvants to help boost the immune response.
Adults with existing health conditions and those with compromised immune systems must consult their doctors when deciding which type of vaccine will be most appropriate for them.
The pharmaceutical industry’s commitment to develop, manufacture, and make vaccines available stem from the belief that no one is really safe unless everyone is safe from COVID-19.
Teodoro B. Padilla is the executive director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP). PHAP and its member companies represent the research-based pharmaceutical sector in the country.