Major Milestones in the Race to Vaccinate Every American Against COVID-19

A month into the unexplained pneumonia outbreak in Wuhan, China, scientists published a draft genome of the novel coronavirus. A DNA sequence of the virus is what researchers need to reverse-engineer a live virus, which can then be helpful in developing antibody tests and starting experiments for possible treatments and vaccines.

The Department of Health and Human Services starts working with New Jersey-based Janssen Research & Development, part of Johnson & Johnson, and Moderna of Cambridge, Massachusetts, in order to expedite the development and manufacturing of COVID-19 vaccines. The Moderna vaccine candidate uses mRNA, an innovative approach that has not yet been used in approved vaccines against any disease..

A clinical trial of a COVID-19 vaccine in Germany is approved. The trial is set to include 200 healthy volunteers between the age of 18 and 55, who will receive different doses of the vaccine, developed by German biotech company BioNTech and its partner, New York-based pharmaceutical giant Pfizer. Like the Moderna vaccine, the Pfizer/BioNTech vaccine candidate uses mRNA technology.

The Trump Administration announces Operation Warp Speed (OWS), a national program to help the development, manufacturing, and distribution of COVID-19 vaccines across the country once they become available.

The federal government and British-Swedish drugmaker AstraZeneca announce a collaboration to speed the development of a COVID-19 vaccine. HHS says it expects the first doses — at least 300 million of them — to be available as early as October 2020. Phase 3 clinical trials are set to be conducted during the summer.

Moderna announces that the company would enter the third stage of its clinical trial, required for regulatory approval, in July with 30,000 participants. The company says it can produce between 500 million to 1 billion doses by the beginning of 2021.

The 45 patients who were given the Moderna’s COVID-19 vaccine produced antibodies that could neutralize the novel coronavirus that causes the disease, according to preliminary data from an early-stage trial. Some minor side effects such as chills and pain at the injection site have been observed in more than half of the volunteers.

An experimental vaccine from AstraZeneca in collaboration with Oxford Vaccine Group and another from CanSino Biologics, a Chinese vaccine company, show promising results in providing protection against COVID-19. The Oxford/AstraZeneca vaccine generated robust immune responses against the virus in all participants in a Phase 1/2 trial, according to results published in The Lancet.

The CanSino vaccine was effective in 95% of patients who were still showing immune responses 28 days after vaccination, according to Phase 2 results also published in The Lancet.

HHS and the Department of Defense announce a partnership with Pfizer and BioNTech, which commit to deliver 100 million doses of their COVID-19 vaccine candidate by December 2020. If approved by the FDA, the companies will receive $1.95 billion for manufacturing of the vaccine, which will be available for free to the general public.

The first Phase 3 clinical trial of the coronavirus vaccine developed by biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases begins in the United States. The trial is to be conducted at nearly 100 research sites and aims to enroll approximately 30,000 adults who do not have COVID-19.

As the U.S. experiences a second surge of the pandemic, the federal government announces a deal to pay $2.1 billion to GlaxoSmithKline and Sanofi Pasteur, a British and French pharmaceutical companies, to develop, manufacture, and scale up delivery of a COVID-19 vaccine.

Russia announces that its health regulator has approved a coronavirus vaccine for widespread use, becoming the first country in the world to do so. The news, however, is met with much skepticism by scientists across the world who accuse Russia of skipping large trials aimed to test the vaccine’s safety and efficacy.

The U.S. government agrees to pay Moderna $1.53 billion for 100 million doses of its vaccine candidate, or an average of $15 per-dose. The vaccine is still under investigation in Phase 3 trial, with the results expected around October. Moderna has already received almost $1 billion from the government for developing the vaccine.

According to published results, the Pfizer/BioNTech vaccine produced mild side effects such as mild fever and body aches in fewer than 20% of participants. Older participants tended to have less reaction than younger ones. However, lower neutralizing antibody response was observed in the older participants.

The U.S. government says it will not participate in an initiative by the World Health Organization to develop, make, and distribute a COVID-19 vaccine. The initiative, coined COVAX, was launched so that an eventual vaccine can be distributed evenly to at least 20% of the population of the 172 participating nations.

Sanofi and GSK start a human clinical trial of their protein-based vaccine, which uses the same protein-based technology as one of Sanofi’s flu vaccines and is combined with a vaccine developed by GSK. About 440 adults in the U.S. will participate.

AstraZeneca pauses its COVID-19 vaccine trial after unexplained illness in one participant. The move is just a precaution and a routine action, according to the drug giant. At this time, the AstraZeneca vaccine is one of three COVID-19 vaccines in late-stage, Phase 3 trials in the U.S.

After initially recruiting participants, Pfizer and BioNTech announce they will expand the Phase 3 trial of their COVID-19 vaccine to 44,000. The goal is to increase data on safety and efficacy as well as to include a more diverse population, including younger people, minorities, and those with pre-existing conditions.

A vaccine distribution plan, devised by HHS and the DOD, aims to make COVID-19 vaccines free for all Americans, with vaccine roll out set for January 2021. Once a vaccine is authorized, 6.6 million kits of supplies will be distributed to administer up to 660 million doses of the vaccine. No decision on who will be the first to receive the vaccine is made yet.

Johnson & Johnson begins a large Phase 3 clinical trial of its COVID-19 vaccine candidate. With 60,000 participants, the trial is the largest of any COVID-19 vaccine being tested at the time. The vaccine does not need to be frozen and may require only one dose instead of two.

The Moderna vaccine, which is being developed in partnership with the National Institutes of Health, has been tested in 40 adults 56 and older. The vaccine is found to safely trigger an immune response in that age group, according to the preliminary findings.

Johnson & Johnson pauses its COVID-19 vaccine trial over a participant’s “unexplained illness,” though it is unclear whether the patient was receiving the vaccine or the placebo. The study includes 60,000 volunteers.

AstraZeneca and Johnson & Johnson announce plans to restart clinical trials for their respective COVID-19 vaccine candidates after they both stopped due a participant falling sick. Johnson & Johnson’s trial stalled on Oct. 12, and AstraZeneca halted its study on Sept. 6. An independent monitoring committee determined that the trial for the AstraZeneca vaccine candidate was safe to continue.

Moderna announces that its experimental vaccine is 94.5% effective in preventing COVID-19. Like Pfizer’s vaccine, the Moderna vaccine uses mRNA, an innovative approach that has not yet been used in approved vaccines against any disease.

The results of a nearly 44,000-person trial demonstrate that the Pfizer-BioNTech COVID-19 vaccine is 95% effective, making it as effective as vaccines for shingles and measles. Pfizer also announces that it will seek FDA approval soon so distribution of the vaccine can start by the end of 2020.

When AstraZeneca’s COVID-19 vaccine is administered as a half dose followed by a full dose at least a month later, the vaccine can be up to 90% effective (a discovery made by accident). The drugmaker says it can have as many as 200 million doses by the end of 2020 and 700 million by the end of the first quarter of 2021.

In the U.K., a 90-year-old woman becomes the first person in the world to be given the Pfizer-BioNTech COVID-19 vaccine as part of a mass vaccination program. People who are 80 and over and who are either in a hospital or are being discharged after a hospital stay are the first to receive the vaccine in the U.K.

The FDA agrees to issue an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine, allowing shipments to begin. Vaccinations of health care workers are to begin within days.

The Pfizer-BioNTech vaccine against COVID-19, the first federally approved coronavirus vaccine in the U.S., is administered to health care workers and staff at nursing homes nationwide.

The FDA confirms the effectiveness and safety of the Moderna COVID-19 vaccine, clearing a path to authorization. The potential second COVID-19 vaccine is found to be 95% effective.

The FDA issues an EUA for the Moderna COVID-19 vaccine, allowing shipments to begin. The vaccine has been deemed safe for people 18 and older. (The Pfizer-BioNtech vaccine can be used in people 16 years and older.)

A week after the first doses of the Pfizer-BioNTech coronavirus vaccine are administered in the U.S., a new batch of vaccines, made by Moderna, fan out across the country. Moderna’s vaccine rollout is four times larger than Pfizer’s.

The U.S. government announces it will buy an additional 100 million doses of Pfizer-BioNTech’s vaccine. At least 70% of the doses must be delivered by June 30, 2021, and all of them no later than July 31, 2021.

The U.K. becomes the first country to provide an emergency authorization of the AstraZeneca COVID-19 vaccine for people 18 and older. The goal is to vaccinate 2 million people a week in the country.

About two weeks after the announcement of a new, more contagious variant of the coronavirus, the British government decides to begin giving as many people as possible a first vaccine dose rather than holding back supplies for the second shots as a way to speed up vaccinations.

The federal government does not meet its goal to administer 20 million coronavirus vaccines by year-end due to logistical problems and underfunded health departments. By Dec. 31, 2.8 million people receive the first of two doses needed to provide immunity to the virus, according to the CDC.

The U.K. starts rolling out 500,000 doses of the coronavirus vaccine developed by AstraZeneca and the University of Oxford, a week after the shot was approved. The U.K. government has an agreement for 100 million doses, enough for 50 million people.

The U.S. government announces it will buy 200 million more doses of the COVID-19 vaccines that have so far been approved for use in the country, a step that may provide enough doses to fully inoculate almost every American eligible for the vaccine by the end of the summer.