COVID-19 vaccines are designed to provide immunity against SARS-CoV-2, the virus responsible for the COVID-19 disease. These vaccines aim to reduce the severity of illness, hospitalizations, and deaths associated with COVID-19.
By 2003, vaccines were already in use for several animal diseases caused by coronaviruses, indicating the potential for developing similar vaccines for humans.
Studies published in 2005 and 2006 highlighted the international effort to develop vaccines and treatments for SARS, recognizing the need for preparedness against emerging infectious diseases.
The emphasis on developing vaccines and treatments for SARS continued into 2006, with no proven solutions available yet.
Building on decades of research, Moderna initiated human trials of an mRNA vaccine in 2015, demonstrating the potential of this technology.
The virus causing COVID-19, SARS-CoV-2, emerged in 2019.
SARS-CoV-2, the virus responsible for COVID-19, was first isolated in late 2019. This marked a critical step in understanding the virus and paved the way for vaccine development efforts.
Starting January 2020, timelines for clinical research were compressed, with safety, efficacy, and dosing trials running concurrently. This approach, while faster, potentially compromised safety assurances. For example, Chinese researchers began their efforts in January 2020 and were already pursuing numerous candidates by March.
The genetic sequence of SARS-CoV-2, the virus causing COVID-19, was made public on January 11, 2020. This publication triggered a global response to prepare for a potential outbreak and accelerated the development of a vaccine.
Beginning in January 2020, vaccine development saw an unprecedented level of collaboration between the multinational pharmaceutical industry and governments, accelerating the process significantly.
In February 2020, the World Health Organization (WHO) stated that a vaccine against SARS‑CoV‑2 was not expected to be available for at least 18 months. This prediction highlighted the challenges and time required for vaccine development.
On February 4, 2020, the US Secretary of Health and Human Services, Alex Azar, invoked the Public Readiness and Emergency Preparedness Act (PREP Act) to provide liability protections for COVID-19 vaccine manufacturers and health care providers. This declaration precluded liability claims for negligence, provided there was no willful misconduct, and was effective through October 1, 2024.
By March 2020, one DNA-based MERS vaccine had completed Phase I clinical trials, and three more were underway. This research on MERS vaccines proved valuable for the subsequent development of COVID-19 vaccines.
In April 2020, the G20, WHO, and other partners launched the Access to COVID‑19 Tools Accelerator to share resources and knowledge for combating the pandemic. The WHO also documented plans for large-scale clinical trials to evaluate promising vaccine candidates.
In April 2020, the UK government established a dedicated task force to accelerate vaccine development within the country. The task force facilitated collaboration across industries, universities, and government agencies.
In April 2020, the UK announced a commitment to global collaboration on COVID-19 vaccine development and distribution. Partnering with 20 other countries and global health organizations, including France, Germany, and Italy, the UK pledged to share research findings and ensure equitable access to vaccines. The UK government emphasized that its citizens would not receive preferential treatment for vaccines developed with taxpayer funding. Concurrently, several pharmaceutical companies announced plans to initially offer vaccines at lower prices to ensure accessibility, with potential price increases later to ensure sustainability and profitability, especially if annual vaccinations become necessary.
The US government launched Operation Warp Speed in May 2020, a fast-track program aimed at accelerating the development, manufacturing, and distribution of COVID-19 vaccines.
China granted limited approval to the CanSino vaccine for use in the military in June 2020. Additionally, two inactivated virus vaccines were approved for emergency use in high-risk occupations.
By June 2020, tens of billions of dollars had been invested globally in COVID-19 vaccine development. The funds came from various sources, including corporations, governments, international health organizations, and university research groups.
Russia announced the approval of its Sputnik V vaccine for emergency use in August 2020. However, distribution outside of the ongoing phase 3 trial remained limited a month later.
In September 2020, eleven vaccine candidates in clinical development were reported to use adjuvants. Adjuvants enhance the immune response to an antigen, making the vaccine more effective. Aluminum salts, or "alum", were commonly used and known to boost immunogenicity.
The TRIPS waiver, intended to suspend intellectual property rights for COVID-19 vaccines, was initially proposed in October 2020 to enhance global vaccine access.
By November 15, 2020, a concerning trend emerged in global COVID-19 vaccine distribution. Despite representing only 14% of the global population, high-income countries had pre-ordered 51% of all available vaccine doses. Some of these countries secured enough doses to vaccinate their populations multiple times over, raising concerns about vaccine hoarding and inequitable access for lower-income nations.
The Pfizer–BioNTech collaboration submitted an Emergency Use Authorization (EUA) request to the US FDA for their mRNA vaccine, BNT162b2, in November 2020.
December 2020 saw reports of rare but severe allergic reactions, including anaphylaxis, following administration of the Pfizer-BioNTech and Moderna COVID-19 vaccines. Lipid nanoparticles were suspected as a potential trigger.
In December 2020, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted temporary approval to the Pfizer–BioNTech vaccine. This marked the first approval of this vaccine and the first approval of any COVID-19 vaccine in the Western world. By December 21, 2020, many countries and the EU had also authorized or approved the vaccine.
In December 2020, the UK government granted Pfizer legal indemnity for its COVID-19 vaccine. This move was part of the broader efforts to expedite vaccine rollout and ensure public access to vaccination, despite potential legal risks.
By December 2020, countries began implementing phased distribution plans for COVID-19 vaccines, prioritizing high-risk groups such as the elderly and healthcare workers. Over 10 billion vaccine doses had also been preordered by this time.
In 2020, leveraging prior knowledge about coronaviruses, scientists rapidly developed the first COVID-19 vaccines, which were made available to the public through emergency authorizations. Most of these vaccines were two-dose vaccines.
In 2020, various vaccine technologies, including nucleic acid-based approaches, viral vectors, and more, were being utilized to develop COVID-19 vaccines, illustrating the breadth of scientific innovation.
In 2020, as the COVID-19 pandemic rapidly spread, international organizations like the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) recognized the critical need for equitable global vaccine distribution. They highlighted potential challenges, including vaccine nationalism, where countries prioritize their own citizens, and price disparities driven by market forces. Experts stressed the importance of ensuring affordable access to licensed vaccines, particularly for frontline healthcare workers and vulnerable populations most at risk.
In January 2021, WHO Director-General Tedros Adhanom Ghebreyesus issued a stark warning about the growing disparity in COVID-19 vaccine distribution. He highlighted that while over 39 million vaccine doses had been administered in at least 49 higher-income countries, only 25 doses had been administered in one of the lowest-income countries. This stark contrast underscored the significant inequities in vaccine access, raising concerns about vaccine nationalism and the potential for a two-tiered recovery from the pandemic.
Monitoring of allergic reactions associated with the Moderna COVID-19 vaccine continued into January 2021, with ten cases of anaphylaxis reported.
In March 2021, Covaxx, the developer of the UB-612 vaccine, raised $1.35 billion through a private placement. This fundraising effort was part of a for-profit venture led by Erik Prince, the founder of Blackwater, despite the lack of clinical trial data on the vaccine's safety and efficacy.
In March 2021, reports emerged of the US discouraging Brazil from purchasing Russia's Sputnik V vaccine due to concerns about Russian influence. Additionally, accusations arose of countries like Israel and China obstructing vaccine access for Palestine and Taiwan, respectively, highlighting vaccine nationalism.
By March 2021, the Biomedical Advanced Research and Development Authority (BARDA) had invested an estimated $19.3 billion in COVID-19 vaccine development.
A March 2021 report by Brazilian journalism agency Agência Pública revealed that individuals identifying as white in Brazil were receiving vaccinations at twice the rate of those identifying as Black, highlighting racial disparities in the country's vaccine rollout.
In March 2021, a group of developing nations proposed waiving COVID-19 vaccine patent rights at the WTO, aiming to increase vaccine production for poorer countries. However, this initiative faced resistance from the US, Britain, EU member states, and others.
In March 2021, Russia announced the registration of Carnivac-Cov, the first COVID-19 vaccine specifically designed for animals. This inactivated vaccine targets carnivorous animals, including pets, aiming to prevent viral mutations that might occur during transmission between species.
In April 2021, the World Health Organization's emergency committee convened to discuss concerns regarding the unequal distribution of COVID-19 vaccines globally.
By May 2021, data revealed a stark disparity in global vaccine distribution, with the world's 29 poorest countries, representing 9% of the global population, having received a mere 0.3% of all vaccines administered.
In May 2021, UNICEF issued an urgent plea to industrialized nations, urging them to share their excess COVID-19 vaccine supplies to address a 125 million dose shortage within the COVAX program. This shortage was partly attributed to India's Serum Institute, a key vaccine supplier for COVAX, prioritizing domestic needs.
In May 2021, the US government under President Biden shifted its stance and expressed support for waiving intellectual property protections for COVID-19 vaccines. The European Parliament also passed a motion advocating for the temporary lifting of these rights.
In June 2021, a report revealed that the UB-612 vaccine, developed by the US-based Covaxx, was a for-profit venture led by Blackwater founder Erik Prince. Despite raising $1.35 billion in a private placement in March 2021, Covaxx failed to provide clinical trial data on the vaccine's safety and efficacy. Distribution networks were to be managed by Windward Holdings, a firm solely owned by Prince and responsible for professional, scientific, and technical activities.
Between March and June 2021, the Serum Institute of India faced significant supply challenges due to rising domestic vaccine demands, impacting the global availability of COVID-19 vaccines.
By July 2021, research and development efforts for COVID-19 vaccines explored at least nine different technology platforms, showcasing the global effort to find effective solutions.
In July 2021, leaders from the World Bank Group, IMF, WHO, and WTO released a joint statement emphasizing the urgent need to improve vaccine access for developing countries to combat the COVID-19 pandemic effectively.
By August 2021, the Delta variant had become the dominant strain of SARS-CoV-2 in the US, accounting for 99% of cases. The CDC reported a decline in vaccine effectiveness against this variant, dropping from 91% against the Alpha variant to 66% against Delta. This variant also significantly increased the risk of severe illness and hospitalization among unvaccinated individuals. Despite the reduced effectiveness, experts emphasized that vaccinated individuals who contracted the virus were significantly less likely to experience severe symptoms, hospitalization, or death compared to unvaccinated individuals.
In August 2021, the WHO urged a moratorium on booster doses until at least the end of September, aiming to prioritize vaccine distribution to countries with low vaccination rates. However, this call faced criticism and resistance from some countries.
Amidst the surge in Delta variant cases in August 2021, the developers of the Sputnik V vaccine proposed that Pfizer test their Ad26 component as a potential booster shot.
September 2021 saw over 140 former world leaders and Nobel laureates urging candidates for the German Chancellorship to publicly support the waiving of intellectual property rules for COVID-19 vaccines to improve global access.
In September 2021, Médecins Sans Frontières (Doctors Without Borders) organized a Day of Action to advocate for the TRIPS waiver and pressure the WTO to address vaccine inequities at their upcoming ministerial meeting.
During his address at the UN General Assembly in September 2021, Peruvian President Pedro Castillo advocated for an international treaty to ensure equitable vaccine access, highlighting the need for global solidarity in the face of the pandemic.
As of September 2021, vaccine inequity was causing significant economic damage globally. Wealthy countries had an excess supply of vaccines, while many others faced severe shortages, affecting their economies due to under-vaccination, deaths, disabilities, and lockdowns. The economic loss was notable in both under-vaccinated and over-vaccinated countries, with high-income countries potentially losing more money, although poorer countries faced a higher percentage loss of GDP and long-term effects. High-income countries were estimated to gain US$4.80 for every $1 spent on providing vaccines to lower-income countries.
In November 2021, nursing unions from 28 countries lodged a formal complaint with the United Nations, challenging the refusal of the UK, EU, Norway, Switzerland, and Singapore to temporarily suspend patents on COVID-19 vaccines.
In November 2021, the UK Medicines and Healthcare products Regulatory Agency made public the full nucleotide sequences of the AstraZeneca and Pfizer/BioNTech vaccines. This disclosure came in response to a freedom of information request, shedding light on the genetic makeup of these widely used vaccines.
A November 2021 study conducted by the European Centre for Disease Prevention and Control (ECDC) estimated that vaccination efforts had averted approximately 470,000 deaths among individuals aged 60 and older within the European region since the rollout of COVID-19 vaccines.
As of December 2021, no FDA-authorized or approved tests were available for healthcare providers or the public to reliably determine an individual's level of protection against COVID-19 infection. This underscored the ongoing challenge in accurately assessing individual immunity and emphasized the continued importance of vaccination, masking, and other preventive measures.
In early December 2021, CDC data revealed a striking difference in mortality risk between unvaccinated and boosted individuals. According to the data, unvaccinated adults faced a 97 times higher risk of dying from COVID-19 compared to fully vaccinated individuals who had also received booster doses. This highlighted the crucial role of booster shots in enhancing protection against severe outcomes, particularly as new variants like Omicron emerged.
On December 10, 2021, the UK Health Security Agency released preliminary data showing a significant reduction in the neutralizing activity of the Pfizer two-dose vaccine against the Omicron variant compared to previous strains. The data indicated a 20- to 40-fold decrease in effectiveness. However, booster doses, primarily using mRNA vaccines, demonstrated a significant improvement in protection. Following a booster, vaccine effectiveness against symptomatic disease rose to 70%-75%, and experts anticipated even higher effectiveness against severe illness.
The June 2022 study analyzing the impact of COVID-19 vaccines included data up to December 2021, highlighting the ongoing role of vaccination in reducing deaths.
Throughout 2021, studies consistently demonstrated that fully vaccinated individuals and those with prior SARS-CoV-2 infection exhibited a low risk of subsequent infection for a minimum of six months. However, research remained inconclusive about the specific antibody titer threshold indicative of reliable protection against infection. While studies established a correlation between antibody levels and protection at a population level, the threshold for individual protection remained unknown. Furthermore, studies indicated variations in protection levels against different viral variants, particularly among vulnerable populations such as the elderly and immunocompromised.
In 2021, the CDC published a report highlighting the real-world effectiveness of COVID-19 vaccines. The report emphasized that vaccination significantly reduced infections, hospitalizations, and deaths. However, it also noted that while vaccines offered robust protection against severe illness, their efficacy against mild cases was comparatively lower, and this protection decreased over time, necessitating booster shots. The CDC specifically stated that unvaccinated individuals faced a 10 times higher risk of hospitalization and an 11 times higher risk of death from COVID-19 compared to fully vaccinated individuals.
In March 2022, research revealed that while COVID-19 vaccination provided strong initial protection against severe illness, hospitalization, and death for elderly residents of English care homes, this protection waned significantly over the months following vaccination. In contrast, younger care home staff experienced a much slower decline in protection. This finding led to recommendations for regular booster shots for older adults, particularly those in care homes, with a suggested frequency of every six months to maintain optimal protection.
In March 2022, the US Centers for Disease Control and Prevention (CDC) expanded its vaccination recommendations to include a fourth dose of the Pfizer mRNA vaccine for specific groups at higher risk. This recommendation targeted immunocompromised individuals and those aged 50 and above, recognizing their increased vulnerability to severe COVID-19 and the potential for waning immunity over time.
In March 2022, the World Health Organization highlighted the significant disparity in COVID-19 vaccine distribution, with only one percent of the 10 billion doses given worldwide administered in low-income countries. They called for 70 percent global vaccination by mid-2022 and estimated that an additional 6 billion doses were needed to address vaccine access gaps, particularly in developing countries. They recommended the use of whole inactivated virus (WIV) and protein-based vaccines to support this effort.
In March 2022, the White House released its "National COVID-19 Preparedness Plan," which included a recommendation to accelerate the development of a universal coronavirus vaccine.
A promising universal coronavirus vaccine candidate, utilizing a spike ferritin-based nanoparticle (SpFN), entered Phase I clinical trials in April 2022.
In May 2022, the FDA issued a bulletin restricting the use of the Janssen COVID-19 vaccine due to concerns over rare blood clotting events known as thrombosis with thrombocytopenia syndrome (TTS). The FDA maintained that the vaccine's benefits outweighed its risks but advised limiting its use to specific cases.
A June 2022 study estimated that COVID-19 vaccines prevented millions of deaths globally between December 2020 and December 2021.
In June 2022, Pfizer and Moderna announced a significant advancement in vaccine technology with the development of bivalent COVID-19 vaccines. These new vaccines were designed to target both the original SARS-CoV-2 wild-type strain and the Omicron variant, offering broader protection. Studies demonstrated that these bivalent vaccines were well-tolerated and elicited a stronger immune response against Omicron compared to previous mRNA vaccines.
By September 2022, despite significant global progress in COVID-19 vaccination efforts, disparities in vaccine access persisted. Data highlighted that only 22.3% of the population in low-income countries had received at least one vaccine dose, underscoring the stark inequities in vaccine distribution. This emphasized the urgent need for increased global cooperation and resource allocation to ensure equitable access to vaccines, particularly for vulnerable populations in low-income nations.
In September 2022, the European Union transitioned COVID-19 vaccines from conditional marketing authorizations to standard authorizations. Despite this change, purchasing contracts with vaccine manufacturers remained confidential and did not include liability exemptions for unknown side effects at the time of licensure.
Marking a pivotal moment in the fight against COVID-19, the United States Food and Drug Administration (FDA) granted emergency use authorization for bivalent COVID-19 vaccines in September 2022. Developed by Pfizer and Moderna, these vaccines specifically targeted both the original SARS-CoV-2 strain and the Omicron variant, offering enhanced protection against the circulating strains.
September 2022 marked a milestone with the approval of the first intranasal COVID-19 vaccines, iNCOVACC in India and Convidecia in China, offering potential advantages as boosters, including possible reduction in transmission.
In October 2022, China marked a significant step by commencing the administration of an oral COVID-19 vaccine. Developed by CanSino Biologics, this vaccine utilizes an adenovirus model for its delivery.
By November 2022, forty different COVID-19 vaccines had received authorization for public use from at least one national regulatory authority.
On December 13, 2022, Florida Governor Ron DeSantis announced his intention to petition the state supreme court to convene a grand jury to investigate potential violations related to COVID-19 vaccines. He asserted that his administration would obtain the necessary data from vaccine companies, regardless of their willingness to provide it.
UNICEF criticized the delayed delivery of promised Moderna and Pfizer vaccine donations, most of which were scheduled for late 2021 or early 2022, further hindering global vaccine equity efforts.
In 2022, research revealed that fully vaccinated individuals who experienced breakthrough infections with the Delta variant of SARS-CoV-2 exhibited peak viral loads similar to those seen in unvaccinated cases. This finding indicated that even with vaccination, individuals infected with the Delta variant could still transmit the virus to others, particularly in household settings. The study emphasized the importance of continued vigilance and preventive measures, even among vaccinated individuals, to mitigate the spread of the virus.
In February 2023, a systematic review published in The Lancet medical journal compared the protection offered by prior SARS-CoV-2 infection to that provided by vaccination. The review found that while previous infection offered a level of protection comparable to vaccination, it came with a significantly higher risk of severe illness and death from the initial infection itself. This highlighted the safer and more effective approach of vaccination in achieving immunity against COVID-19.
In March 2023, the European Union granted approval for the use of Bimervax as a booster vaccine against COVID-19.
Katalin Karikó and Drew Weissman were awarded the 2023 Nobel Prize in Physiology or Medicine for their groundbreaking work in developing effective mRNA vaccines against COVID-19.
As of January 3, 2024, global COVID-19 vaccination efforts reached a significant milestone, with over 13.53 billion doses administered worldwide. This translated to 70.6% of the global population having received at least one vaccine dose. Despite this progress, disparities in vaccine access persisted, with low-income countries lagging significantly behind. Data from Our World in Data, compiling reports from national health agencies, indicated that only 22.3% of people in low-income countries had received at least one vaccine dose by September 2022. At the time, approximately 4.19 million vaccine doses were being administered daily.
The liability shields provided under the US Public Readiness and Emergency Preparedness Act (PREP Act) for COVID-19 vaccine manufacturers and health care providers will remain effective until October 1, 2024. This protection precludes liability claims for any injuries resulting from vaccine administration during this period, except in cases of willful misconduct.
By May 2024, over 13.58 billion COVID-19 vaccine doses had been administered globally, according to official reports.