Here’s a list at some of the ongoing COVID-19 vaccine projects:
1. Pfizer / BioNTech / Fosun Pharma. Drugmaker Pfizer teamed up German biotech company BioNTech and Chinese drugmaker Fosun Pharma to develop a two-dose mRNA vaccine.In mid-August, company officials said the vaccine had produced a “robust” response in a phase 1/2 clinical trial.
The company launched a phase 3 trial in late July, with a goal to recruit 30,000 people from the United States, Brazil, Argentina, and Germany. They later announced plans to increase this to 44,000 people. In October, the company said it received approval to enroll children as young as 12 years in the trial — the first American trial to include this age group.
As of late October, the trial had enrolled more than 42,000 people. At the time, the company had not yet conducted an interim analysis of the study data, which puts it behind its original goal of doing so by September. However, the company still expects to have enough data sometime in November to apply for emergency use authorization from the FDA.
On November 9, the company announced that its vaccine had been more than 90 percent effective in clinical trial participants.
A few days later, company officials announced they were applying for an emergency use authorization from the FDA for their vaccine. It was the first regulatory approval in the United States for a COVID-19 vaccine. The officials said the vaccine could be available to high-risk groups as early as mid-December.
On December 8, the FDA released documents that reported the Pfizer vaccine offers some protection after the first dose and nearly full protection after a second dose.
*Yesterday,
December 13, vaccines were distributed and transported from Michigan to
all 50 US states after FDA authorization for emergency use and CDC
recommendation.
2. Moderna / National Institutes of Health. The company began testing its two-dose messenger RNA (mRNA) vaccine in March in a phase 1 clinical trial, with promising results.
In late July, Moderna began phase 3 clinical trials of the vaccine.
In late August, company officials said preliminary phase 1 trial data showed that the vaccine elicited a promising immune response in 10 people between the ages of 56 and 70 as well as 10 people over age of 70.
The company announced in late October that it had finished recruiting all 30,000 participants in the phase 3 trial. This included more than 7,000 people over the age of 65 and more than 5,000 younger people with chronic conditions that increase their risk of severe COVID-19.
In early October, company officials announced their vaccine won’t be available for wide distribution until spring 2021. Later in the month, Moderna’s CEO told investors that the trial’s data and safety monitoring board could start analyzing study data in November.
In mid-November, Moderna officials reported that their vaccine had achieved an effective rate of 94 percent in initial phase 3 trial results. Experts said more testing and more information is needed.
On November 30, Moderna officials said they would apply to the FDA for its vaccine to be approved for emergency use. Company executives said the vaccine could be available by December 21 if it receives FDA approval.
3. Inovio. When COVID-19 appeared in December, drugmaker Inovio had already been working on a DNA vaccine for MERS, which is caused by another coronavirus. This allowed the company to quickly develop a potential COVID-19 vaccine.
Company officials announced at the end of April that it had enrolled 40 healthy volunteers in its phase 1 trial. In late September, the company announced that its phase 2/3 trial is on hold as the it responds to the FDA’s questions about the study.
4. Sanofi / Translate Bio. Drugmaker Sanofi announced in February that it would work with Translate Bio to develop an mRNA vaccine. Preclinical testing showed that the vaccine could elicit a strong immune response in mice and monkeys. The company expects results from its phase 2 trial in early December. After that, they will start a phase 3 study.
5. CanSino Biologics. Scientists at this Chinese company are also working on a potential vaccine that uses an adenovirus known as Ad5 to carry coronavirus proteins into cells.
In late July, they reported that participants in a phase 2 trial showed a strong immune response when given the vaccine. However, they noted older adults had a weaker response, suggesting two doses might be needed for that segment of the population.
The Chinese military approved the vaccine in June, allowing the vaccine to be given to its armed forces. In August, the company began phase 3 trials in Pakistan, Saudi Arabia, and Russia.
6. Gamaleya Research Institute. This Russian institute developedTrusted Source a vaccine that includes two adenoviruses, Ad5 and Ad26.
In August, President Vladimir Putin announced that the country’s regulatory agency had approved the vaccine, even before phase 3 trials had started. Russian officials later said the vaccine had received a “conditional registration certificate.”
Results of a phase 1/2 trial found that the vaccine elicited an immune response with mild side effects. Phase 3 trials are currently under way in Russia, Belarus, United Arab Emirates, and India.
7. Johnson & Johnson. Drugmaker Johnson & Johnson announced in late July that it had begun a phase 1/2 trial in people after their adenovirus vaccine had shown promising results when used in monkeys.
In late September, the company announced it was starting a phase 3 trial of its one-dose vaccine with 60,000 participants. In mid-October, the company announced it was pausing this trial due to an “unexplained illness” with one of the participants. The company has since received permission to restart the study.
In mid-November, Johnson & Johnson officials said they expected their vaccine to be ready for FDA approval by February.
8. AstraZeneca / University of Oxford. A phase 1 clinical trial at the University of Oxford began in late April. The vaccine is based on a chimpanzee adenovirus, which shuttles coronavirus proteins into cells.
In August, AstraZeneca began phase 3 trials in Brazil, South Africa, and the United StatesTrusted Source. These trials were halted in September when a study volunteer developed a rare spinal inflammatory disorder called transverse myelitis. The trials were restarted a week later in Brazil and the United Kingdom. In late October, the FDA authorized the U.S. trial to resume.
In mid-November, company officials said their vaccine had produced a strong immune response in a clinical trial that involved people over the age of 70.
Data released on December 8 indicated that the vaccine was safe but only about 70 percent effective.
9. Sanofi / GSK / TranslateBio. Drugmaker Sanofi is pursuing two vaccines. The company is working with drugmaker GSK on a vaccine based on proteins from the coronavirus. When combined with another compound, called an adjuvant, the proteins elicit an immune response. They expect results from a phase 2 trial in early December, after which they will begin a phase 3 study.
Sanofi is also working with biotech company Translate Bio to develop an mRNA vaccine. They expect to start clinical trials in December.
10. Novavax. This company received up to $388 million in funding this spring from the Coalition for Epidemic Preparedness Innovations (CEPI), a group that has funded COVID-19 vaccine development. The vaccine is made by attaching virus proteins to microscopic particles.
In August, Novavax launched a phase 2 trial in South Africa. A month later, the company began a phase 3 trial in the United Kingdom. It plans to start another phase 3 trial in the United States by the end of November.
11. University of Queensland in Australia / CSL. Researchers at the university developed a vaccine by growing viral proteins in cell cultures. They began preclinical testing stages in early April. The phase 1 trial in people began in early July. A phase 2/3 trial is expected to start late this year.
12. Wuhan Institute of Biological Products / Sinopharm. Chinese company Sinopharm is testing an inactivated virus vaccine developed by the Wuhan Institute of Biological Products. After a successful phase 1 trialTrusted Source, researchers launched phase 3 trials in the UAE in July and a month later in Peru and Morocco.
13. Beijing Institute of Biological Products / Sinopharm. Sinopharm is testing a second inactivated virus vaccine developed by Beijing Institute of Biological Products.
Phase 3 trials began in June in the UAE and in September in Argentina. In September, the UAE approved the vaccine for use on healthcare workers even before the results of the phase 3 trials.
14. Sinovac Biotech. This Chinese company launched phase 3 trials of its inactivated virus vaccine in Brazil in July, Indonesia in August, and Turkey in September. In August, the Chinese government issued emergency approval for the vaccine for use on high-risk groups.
15. Bharat Biotech / Indian Council of Medical Research / Indian National Institute of Virology. Indian company Bharat announced in late October that it was beginning a phase 3 trial of its inactivated virus vaccine.
Murdoch Children’s Research Institute in Australia is conducting a phase 3 trial of the bacillus Calmette-GuĂ©rin (BCG) tuberculosis vaccine to see if it also protects people from the coronavirus. This trial is being run in Australia, Brazil, the Netherlands, Spain, and the United Kingdom.
Some scientists think the polio vaccine might boost the immune system just enough to fight off the new coronavirus, although there’s no evidence yet to confirm this theory.
Two U.S. researchers also suggested that the measles, mumps, rubella (MMR) vaccine might offer protection against inflammation and sepsis in people with COVID-19. They recommend starting a clinical trial with the MMR vaccine in healthcare workers.
Antivirals are drugs that are used for treating viral infections. Some antivirals target specific viruses, while others work against a number of viruses.
These drugs can work in different ways such as preventing the virus from entering host cells, replicating, or releasing viral particles to infect other cells.
Here are some of antivirals being eyed as treatments for COVID-19. Many of these have been approved for other conditions or have been tested on other viruses.
Remdesivir (brand name Veklury). Developed a decade ago, remdesivir failed in clinical trials against Ebola in 2014. But it was found to be generally safe in people.
Research with MERS, a disease caused by a different coronavirus, showed that the drug blocked the virus from replicating.
In April, drugmaker Gilead Sciences announced that preliminary data from a trial of remdesivir overseen by the National Institute of Allergy and Infectious Diseases (NIAID) had “met its primary endpoint.”
Based on these results, the FDA issued an orderTrusted Source on May 1 for the emergency use of remdesivir for hospitalized patients with severe COVID-19.
In August, the agency broadenedTrusted Source the EUA to allow for use of the drug in all hospitalized COVID-19 patients, including children.
The results of a phase 3 trial published in October in the New England Journal of Medicine showed that remdesivir shortened the hospital stay of COVID-19 patients by about 5 days.
People taking remdesivir also had a lower risk of dying compared to those who had been given an inactive control substance.
On Oct. 22, the FDA approvedTrusted Source remdesivir for use as a treatment for COVID-19 in adults and children 12 years and older. The drug is the first approved by the agency as a treatment for COVID-19.
Not all clinical trials have found that remdesivir is effective.
A studyTrusted Source published in The Lancet in May reported that participants in a clinical trial who took remdesivir showed no benefits compared to people who took a placebo.
Preliminary results from a World Health Organization trial released in October found that remdesivir had little effect on how long people stayed in the hospital and no effect on their risk of dying.
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