Coronavirus (COVID-19) Vaccines Latest Updates

Last Updated on Jan 14, 2021

Prelude (Aug, 2020)

Being a virologist, I am often approached these days with the questions: “So, what is the update on COVID vaccines? When do you think we will have one? Is there any hope?” I realized that we hear bits and pieces in the news, read about some in the articles, and find information on clinical progress in the company websites, however, most of this information is rather scattered all over different media. Very few sources will you find where a consolidated snapshot of what we want to know or what we need to know would be presented in a digestible manner. This was the genesis of my blog. I have compiled this COVID-19 vaccine updates on a handful of leading candidates that are proving to be promising. I intend to update this information regularly as we race toward the development of a successful COVID-19 vaccine. Hope you find this information helpful, and more importantly hopeful, amid this dreaded pandemic. The intent behind this page is to provide the most up-to-date vaccine status, progress, and simply put, when will there be a COVID-19 vaccine.

The COVID-19 Vaccine Race: How Soon Can We Have One?

There are >200 potential vaccines currently under development to date, 65 of which are in human trials, and 20 of which are in large scale (Phase 3) clinical trials. To date, 10 COVID-19 (coronavirus) vaccines received emergency and/or limited use authorization—updates on these vaccines are summarized below along with updates on much anticipated Johnson and Johnson vaccine. 3 Chinese and 2 Russian vaccines have been approved for early and limited use; these were approved without waiting for the results of their respective Phase 3 trials. Do note that vaccine experts declared this rushed process to be highly risky. Otherwise, vaccines are considered among the safest medical products.  But when they compromise the intense rigor of the clinical trials, they are almost as if nullifying safety and effectiveness.

NIAID director Dr. Anthony Fauci thinks a return to normalcy could come in 2021 with sufficient availability of COVID-19 vaccine. Vaccine developers shared that they would have tens of millions of doses early in the year, and up to hundreds of millions as we get well into 2021. I should mention that while these trials are in motion, it is not uncommon to witness a pause on trial should the need arise due to safety concerns and consequently getting placed on hold until an independent safety review board clears the pause.

Moderna
(Vaccine: mRNA-1273)

On July 27, Moderna Therapeutics, a Massachusetts based biotech company, kicked off it's phase 3 (late-stage study evaluating large number of individuals) mRNA-based coronavirus vaccine study across 89 U.S. clinical research sites. 30,000 subjects are to be enrolled in the study. Results are expected as early as November 2020. Patients will receive two doses of the mRNA-based shots about four weeks apart. The immune response between the vaccine and placebo (control) arms will be evaluated two weeks after the second dose (ie, starting mid-September). The vaccine could win a speedy approval before year-end if it is successful in the clinic. Dr. Anthony Fauci believes that trial results could arrive by November/December or possibly even earlier, and he remains confident in the vaccine’s safety after reviewing early trial data.

Moderna has already submitted its coronavirus vaccine candidate for regulatory approval in Canada.  In Europe, the European Medicines Agency (EMA, the regulatory agency in Europe that is equivalent to FDA) has formally notified Moderna that their vaccine is eligible for submission of an application for fast-track approval. On November 16,

Nov 17 Update

Moderna announced that its vaccine is 94.5% effective in preventing COVID-19 based on their interim data. The company expects to have enough safety data required for filing for U.S. FDA emergency use authorization (EUA) in the coming weeks. A total of 30,000 trial participants were evaluated. Pending more safety data, Moderna could make available 20 million doses for U.S. by end of this year. Among the participants who received the placebo (no vaccine), 11 became severely ill, but none of the participants who received the actual vaccine became severely ill, including those who are older adults—which is remarkable given that the older adults are quite vulnerable to more serious infection from COVID-19.

Dec 20 Update

On December 18., the U.S. FDA granted emergency use authorization for the Moderna vaccine. 5.9 million doses to be distributed across the United States initially, immediately after the approval. The Moderna vaccine is the second one authorized by the U.S. FDA, a week after the approval of the Pfizer and BioNTech vaccine.

Back in August, the United States government had awarded Moderna an additional $1.5 billion in exchange for 100 million doses, and in December, executed yet another contract for an additional 100 million doses in the second quarter of 2021. Moderna signed an agreement with the European Commission to supply up to 160 million doses. Moderna has executed similar agreements with other countries including Canada, Japan and Qatar.

Jan 15 Update

on January 6, Moderna’s vaccine was authorized by the European Union. Now, Canada , the European Union, Israel, Switzerland and the United Kingdom all have emergency authorization for use. On Dec. 2, Moderna registered a clinical trial to evaluate their vaccine in young adults between 12 and 18 years of age.

The U.S. government awarded Moderna an additional $1.5 billion in exchange for 100 million doses and also executed an agreement for another 100 million doses in the 2nd quarter of 2021. As of Jan. 4, the company had supplied the U.S. with 18 million doses. The company signed a deal with the European Commission to supply up to 160 million doses. They made similar agreements with other countries including Canada, Japan, Qatar and South Korea.

Pfizer and BioNTech
(Vaccine: Comirnaty; also known as tozinameran or BNT 162b2)

Pfizer and BioNTech also launched their late-stage vaccine trial on July 27, initiating the study in the U.S. with plans to expand the study to around 120 sites globally. The partners will administer their nucleoside-modified messenger RNA (modRNA) candidate in a two-dose regimen to an expected 30,000 patients (ages 18 to 85 years) initially. This could win a speedy approval before the year-end provided it is a successful clinical study.

The vaccine partners signed a $1.95 billion deal to deliver 100 million shots to the U.S., as well as 30 million doses in the U.K. by December. If approved, Pfizer expects to manufacture over 1.3 billion doses of its vaccine worldwide by the end of 2021.

Aug 28 Update

Pfizer's vaccine R&D group executive told the CDC on Aug 26 that the clinical trial of the company’s COVID vaccine has enrolled more than 50% of its target subject numbers. FDA Commissioner Stephen Hahn, M.D. recently tweeted that the agency’s vaccine advisory committee would review Pfizer and BioNTech’s vaccine on October 22, depending on having “good scientific data.” Hahn further added that the FDA’s reviewers are “encouraged by the rapid rate of enrollment” in clinical trials. Although the FDA’s website has not listed that committee meeting on their calendar yet. If the company is already halfway to its goal of recruiting 30,000 patients, the company should complete full enrollment by September, meaning the first dataset should come out in mid-September.  There is potential for the complete set of data from the trial to be ready by mid-October, just in time for the anticipated FDA committee meeting in October.

When the vaccine arrives, Pfizer would be facing competition from Moderna, since they too are working on an mRNA vaccine for COVID-19. However, Pfizer definitely has some advantages. Its vaccine is currently the only candidate to have demonstrated responses in both CD4+ and CD8+ T cells in humans—a sign of strong and long-term immune protection. Moreover, Pfizer has a strong infrastructure, commercial expertise, and a proven track record of commercializing vaccines. If all things go well with trial results, first tens of millions of doses of Pfizer’s vaccine may arrive in late October. Of course, this is all things considered with Covid-19 vaccine development in 2020; such as solidarity trials, global development, technology platforms, potential vaccine limitations, proposed challenge studies, licensure issues, commercialization and equitable access, and liabilities to name a few. Let’s take a look at the vaccine candidates.

Oct 17 Update

Pfizer will be testing its coronavirus vaccine in children as young as 12 years of age.  This is crucial because we should test experimental vaccines in diverse groups to assess safety and effectiveness in a broader population, including individuals usually missed or underrepresented in drug and vaccine clinical trials, such as the elderly, children, people with comorbidities, Blacks, Hispanics and Native Americans. Although Covid-19 related mortality in children may be rare, some children do die from it without any indication as to who will make it and who won’t. Some children are also developing a serious post-Covid sickness called multisystem inflammatory syndrome in children or MIS-C.

As of mid-October, Pfizer has enrolled close to 38,000 volunteers in its phase 3 clinical trial. More than 31,000 of them have received the second of two-dose shots. Now with regulatory approval to test in kids, Pfizer has the potential to expand its trial to as many as 48,000 volunteers.  Pfizer has already included 16- and 17-year-olds, as well as comorbid people with HIV, hepatitis B or C in its trial. the company expects data from the study before the end of October with anticipated FDA application for emergency use of Covid-19 vaccine by late November.

Nov 17 Update

On November 9, 2020, Pfizer and BioNTech announced their successful data from a large, late-stage (Phase 3) clinical study at an impeccable time when the nation is facing coronavirus resurgence. The vaccine they developed proved to be more than 90% effective, hitting a major milestone of the vaccine development plan and a much-desired breakthrough. There were a total of 43,538 volunteers who participated in the study and 94 of them ended up contracting COVID-19. Know that the individuals who contracted COVID-19 come from both the vaccinated and unvaccinated (placebo) groups of this study. Vaccine efficacy is measured by comparing the frequency of infections in the vaccinated and the unvaccinated (placebo) groups.

Pfizer's vaccine has to be shipped and stored at -70 degrees C. It can be stored for up to 5 days at standard refrigerator temperatures. During shipment, it can be stored for up to 15 days in a thermal shipping box. Pending more safety data, Pfizer could make available 40 million doses for U.S. by end of this year. The U.S. government could have access to more than 1 billion doses from Moderna and Pfizer next year, which is more than what is needed for 330 million U.S. population.

Nov 22 Update

Pfizer declared that it’s vaccine is 95% effective, even better than their reported interim result of 90%. in older adults, this vaccine was remarkably 94% effective; typically older adults are vulnerable to more serious illness from COVID-19 and do not respond well to some vaccines. UK could give regulatory approval of this vaccine this week, ahead of FDA authorization in the United States. UK will likely start administering this by Dec 1. Meanwhile, FDA will meet on December 10 to discuss potential emergency use authorization in the U.S.

Dec 20 Update

On December 2, the United Kingdom granted emergency authorization to the Pfizer and BioNTech’s vaccine—the first country to give such an approval to a coronavirus vaccine. An 81 year-old was the first man to receive the vaccine on December 8. On December 11, the U.S. FDA granted the Pfizer/BioNTech’s vaccine an emergency use authorization, making it the first ever coronavirus vaccine to have received this authorization in the United States. Pfizer is contracted to supply 100 million doses of the vaccine by next March to the U.S. public for free of charge.

A growing number of other countries across the globe have also granted emergency authorization for this vaccine, including Chile, Costa Rica, Ecuador, Kuwait, Mexico, Panama, and Singapore, while Bahrain, Canada and Saudi Arabia granted the vaccine full approval.

Jan 14 Update

The name of the Pfizer vaccine is Comirnaty. The list of countries who have also given emergency authorization for Comirnaty are: Argentina, Canada, Chile, Costa Rica, Ecuador, Jordan, Kuwait, Mexico, Panama, and Singapore. The European Union signed off on Comirnaty on Dec. 21. Bahrain, Saudi Arabia and Switzerland granted the vaccine full approval. On Dec. 31, the World Health Organization gave Comirnaty an Emergency Use Listing; this will speed up authorization in many other countries.

Pfizer and BioNTech expect to manufacture ~1.3 billion doses by the end of 2021. Pfizer and BioNTech agreed to supply 100 million doses to U.S. by July 2021. Also, Japan made a deal for 120 million doses, the European Union arranged to purchase 300 million doses, and China agreed a get a supply of 100 million doses.

AstraZeneca-Oxford Vaccine
(Vaccine: AZD1222; also known as Covishield in India)

The Serum Institute of India to run late-stage trials on the AstraZeneca-Oxford coronavirus vaccine candidate in healthy adults. SII aims to administer two doses to each subject four weeks apart. The candidate is also in testing in the U.K., Brazil, and South Africa. As a business entity backed by a billionaire family, SII can take huge financial risks. SII is confident that the Oxford-AstraZeneca shot will pan out, and the company aims to have 300 million doses stockpiled for commercial use by the time trials finish around November.

They may deliver emergency vaccines by October 2020. AstraZeneca’s total manufacturing capacity for the vaccine stands at 2 billion doses.

Sep 13 Update

Oxford and AstraZeneca worldwide clinical trials had been put on hold on September 6 after a U.K. participant developed a neurological illness. Within a few days after the trial halt, AstraZeneca announced that its coronavirus vaccine studies have resumed in the U.K. The Oxford and AstraZeneca trial has restarted in U.K. based on the conclusions from an independent review process as well as recommendations from both the independent safety review committee and the U.K. regulator, MHRA. For more information on this, read our post on The Impacts of AstraZeneca's COVID-19 Vaccine Trial Pause: The Good and the Bad.

Nov 17 Update

Within a week after the halt, the trials began in all countries except the United States. Meanwhile, on Oct 21, Brazil reported that a trial participant had died of Covid-19. The trial neither paused, nor did AstraZeneca comment on the case, which led experts to conclude that the participant must have received a placebo control dose instead of the vaccine. On Oct. 23, the trial restarted in the U.S. AstraZeneca expects results from their trial by the end of 2020.

Nov 22 update

Oxford University and AstraZeneca's coronavirus vaccine demonstrated good safety data. Moreover, it boosted a desirable immune response. Most importantly, their vaccine was better tolerated among older adults, who are typically at higher risk of more severe illness. In this phase 2 (smaller, clinical study, 240 out of 560 participants were aged 70 or older. The results were published in The Lancet, a highly esteemed, peer-reviewed journal.

Nov 23 update

On November 23, AstraZeneca’s reported that its vaccine is 70% efficacious according to the Phase III (large) clinical study outcome, and could be 90% effective by tweaking the dosing. This vaccine is cheaper to make, easier to distribute and faster to scale-up than the rival mRNA vaccines. Because this vaccine can be stored at regular fridge, it is ideal for distribution in the developing countries. The company is ready to provide 200 million doses by end of 2020, and ~700 million by the end of first quarter of 2021.

Dec 30 update

On December 30, UK regulator, Medicines and Healthcare products Regulatory Agency (MHRA), has authorized Oxford University/AstraZeneca’s COVID-19 vaccine for use by concluding that the vaccine has met its strict standards of safety, quality and effectiveness. The Joint Committee on Vaccination and Immunization (JCVI) in UK has recommended prioritizing the high-risk individuals their first dose, instead of administering the required 2nd doses in a short time. However, they will receive the 2nd dose within the first 12 weeks, as opposed to first 28 days. The reason for this alternative dosing interval is that some trial participants from the AstraZeneca study had taken the 2nd dose at different intervals, and those who took it between 4 to 12 weeks had achieved an 80% efficacy. JCVI thinks that delaying the 2nd doses will allow UK to deploy the vaccines to as many people as quickly as possible. UK intends to start vaccinating as early as next week.

However, JCVI also recommended this alternative dosing regimen for the Pfizer and Modera vaccines. Pfizer/BioNTech’s and Moderna’s phase three studies were only designed to evaluate the vaccine’s safety and efficacy following a two-dose schedule, separated by 21 and 28 days, respectively. Their safety and efficacy has not been evaluated on different dosing schedules. Most of their study volunteers had received the 2nd dose within the window specified in the study design. Although Pfizer’s data showed that partial protection from the vaccine appears to begin as early as 12 days after the 1st dose, two doses of the vaccine are need for maximum protection against COVID-19—hence an efficacy level of 95% protection. Moreover, there are no data to support that protection after the 1st dose can be sustained after 21 days. In any case, UK’s health authority reserves the right to this decision on alternative dosing interval. But Pfizer has expressed the importance of doing surveillance efforts on any alternative schedules implemented and to ensure that each recipient is given the maximum possible protection with two doses of the vaccine.

Jan 14 update

Now India, Mexico and Argentina has authorized the Oxfold-AstraZeneca vaccine for emergency use. Interestingly, AstraZeneca announced a collaboration with the Russian Sputnik V vaccine (also made from adenoviruses) makers, to see if a combination of two vaccines might increase the efficacy of the Oxford-AstraZeneca vaccine. The trial is planned to start in early 2021 in Ukraine.

The United States awarded $1.2 billion in support for 300 million doses. The European Union reached an agreement to receive 400 million doses. COVAX, an international collaboration that ensures the vaccines are equitably delivered across the world, secured 170 million doses. The total annual manufacturing capacity for AstraZeneca stands at two billion doses.

Gamaleya Research Institute
(Vaccine: Sputnik V (Russian); also known as Gam-Covid-Vac)

The Gamaleya Research Institute, part of Russia’s Ministry of Health, started clinical trials in June on their COVID-19 vaccine called Gam-Covid-Vac, later renamed Sputnik V. Sputnik V is an adenoviral vector based vaccine. On August 11, President Vladimir Putin announced that a Russian health care regulator had approved Sputnik V vaccine, well before the Phase 3 (large scale) human trials had started. Vaccine experts were worried and  deemed this move as risky, not to mention unprecedented in the clinical research field.  Russia later retracted the announcement, claiming the approval was a “conditional registration certificate,” which would be contingent on positive results from Phase 3 trials. Interestingly, these trials were initially evaluating just 2,000 humans, then extended to 40,000. 3 weeks after Putin’s announcement, Gamaleya researchers published the results of their Phase 1/2 trial. In this small study, they reported that Sputnik induced antibodies against the coronavirus for immune protection.  They also reported mild side effects post vaccination. Russia has already agreed to supply the vaccine to other countries including Brazil and Mexico.

Nov 22 update

Russia claimed that its Sputnik V demonstrated 92% efficacy based on results from 20 participants in the trial who developed Covid-19 after receiving either the vaccine or a placebo (no vaccine). Very little scientific data was given to objectively assess their data; and furthermore, it is difficult to make any sense of 20 cases with no detail—not even the study protocol!

Jan 14 update

Still there are no peer-reviewed scientific publication on the phase 3 efficacy /safety data of Sputnik V vaccine. Gamaleya Research Institute tweeted that they had seen that the vaccine had an efficacy of ~90% in people over the age of 60. The clinical trial reduced its planned size from 40,000 to 31,000 participants due to volunteers who suspected they had received the placebo (control group that received no vaccine) dropping out to receive the actual vaccine. This caused concerns among the experts worrying that reduced number of participants would not give enough statistical power to reach strong conclusions with regards to safety and efficacy of Sputnik V.

Interestingly, Gamaleya Research Institute is collaborating with AxtraZenaca to combine their vaccines to see if the mixture can increase the efficacy of the AstraZeneca vaccine. On Dec 24, AstraZeneca registered a Phase 1 trial for the combination vaccine.

Russia has already negotiated a number of supply agreements with other countries, including Brazil, India, Mexico, and Venezuela. Belarus became the first country outside of Russia to register Sputnik V. Argentina Algeria, Bolivia, the Palestinian Authority and Serbia also authorized the vaccine for emergency use.

CanSino Biologics 
(Vaccine: CoronaVac; also known as Ad5-nCoV)

CanSino Biologics, a Chinese company, developed a vaccine based on an adenoviral vector, in collaboration with the Institute of Biology at Academy of Military Medical Sciences in China. Company published promising results from a Phase 1 (early and small) safety trial, and reported that their Phase 2 trials showed a strong immune response generated from vaccination. The Chinese military approved the vaccine on June 25 for a year as a “specially needed drug.” This approval prior to completing phase 3 results is unprecedented in the realm of drug research scientific community.  Experts deem this rushed process to be extremely risky.  On August 9, the Saudi health ministry announced that CanSino Biologics would run a Phase 3 trial in Saudi Arabia, and later in the month they also started a trial in Pakistan. The name of their vaccine is Convidecia.

Sinovac Biotech 
(CoronaVac, formerly known as PiCoVacc)

Another Chinese company Sinovac Biotech is evaluating an inactivated vaccine called CoronaVac. In June, their Phase 1/2 trials on 743 humans found no safety issue, and moreover, the vaccine produced an immune response that is desirable. Sinovac started Phase 3 trials in Brazil and Indonesia. The Chinese government gave the CoronaVac an emergency approval for limited use in July. Again, an approval before the completion of Phase 3 study is unprecedented and is deemed highly risky by the experts. Sinovac is ramping up vaccine manufacturing, and has agreed to supply Indonesia with at least 40 million doses by March 2021. China has already promised the Philippines priority access to a vaccine, and 110,000 free shot doses to Bangladesh.

Jan 14 update

Researchers in Brazil announced that CoronaVac has an overall efficacy of just over 50%. 50% is the minimum threshold set by many regulatory authorities for a coronavirus vaccine approval. Despite this modest efficacy compared to other coronavirus vaccines, CoronaVac is being rolled out in a number of countries, including Indonesia and Turkey—both granted emergency use authorization.

Sinopharm
(Vaccine: BBIBP-CorV) 

The state-owned Chinese company Sinopharm is investigating an inactivated virus vaccine developed by the Beijing Institute of Biological Products. This vaccine is also in Phase 3 trials in the United Arab Emirates (UAE).  Over the summer, the Chinese government gave this vaccine approval for vaccination of hundreds of thousands of people with these two experimental vaccines. Once again, an approval ahead of the completion of Phase 3 trial is unprecedented and is deemed highly risky by the experts. Company’s chairman said that the vaccine could potentially be ready for public use by the end of 2020.

The UAE has approved this vaccine for emergency use for their frontline health workers. 31,000 volunteers have participated in clinical trials of this Chinese vaccine, including 1,000 volunteers with chronic diseases.

Jan 14 update

The name of Sinopharm’s and Wuhan Institute of Biological Product’s vaccine is BBIBP-CorV. On Dec. 30, Sinopharm announced that the vaccine had an efficacy of 79.34%, which lead the Chinese government to grant its approval. The full detail of the phase 3 trial efficacy and safety are NOT published in any peer-reviewed journal yet. The outcome result is slightly contradictory with what UAE has reported from their trial of the same vaccine: an efficacy rate of 86 percent.

China plans to vaccinate 50 million people in China by mid-February. BBIBP-CorV has full approval in UAE and Bahrain, which also participated in the Sinopharm trials. Egypt and Jordan ranted the vaccine emergency authorization.

Sinopharm
(Wuhan Institute of Biological Products) 

The state-owned Chinese company Sinopharm is investigating a second inactivated virus vaccine developed by the Wuhan Institute of Biological Products. The Phase 1/2 trial demonstrated some mild side effects, and generated antibodies to the coronavirus. They started Phase 3 trials in the United Arab Emirates in July, and in Peru and Morocco soon afterwards. This vaccine had gotten authorization for limited use in China and UAE.

Bharat Biotech
(Vaccine: Covaxin; also known as BBV152 A, B, C)

Bharat Biotech partnered with the Indian Council of Medical Research and the National Institute of Virology to develop an inactivated form of the coronavirus called Covaxin. Preclinical animal studies on monkeys and hamsters proved that this inactivated vaccine can provide protection against coronavirus infection. This is the first coronavirus vaccine created in India that has advanced to clinical trials. The phase 1/2 trial showed no serious side effects while it generated antibodies to the coronavirus. Bharat Biotech then advanced to a Phase 3 trial. Company announced a partnership with Ocugen (Pennsylvania-based company) to develop Covaxin for the United States market. The Indian government gave Covaxin emergency authorization despite no release of their Phase 3 data demonstrating the vaccine’s safety and efficacy.

BEKTOP
(Vaccine: EpiVacCorona)

The Vector Institute, a Russian biological research center, initiated a Phase 1/2 trial for their coronavirus vaccine called EpiVacCorona. Thus vaccine contains small portions of viral proteins, or peptides. On Oct. 14, Vladimir Putin announced that Russia has granted regulatory approval to EpiVacCorona, which makes it the second Russian vaccine to receive authorization for early use after the Gamaleya Institute’s Sputnik V vaccine. A Phase 3 trial started in November. Only 1,438 trial participants has received the vaccine as of Dec. 15.

Johnson &Johnson Vaccine
(Vaccine: Ad26.COV2.S; not yet authorized)

It is a single dose of adenovirus-based COVID-19 shot (also known as Ad26.COV2.S that uses the same technology J&J used for Ebola, Zika, HIV and RSV vaccines) that spiked a significant immune response in a preclinical study in non-human primates. Based on the data, J&J moved its candidate into the first stage of human testing in the U.S. and Belgium, and in Phase 3, which started in late September of 2020, as planned. They had enrolled about 800 participants, ranging in ages 18 to 65 in the phase 1/2a study. Both the early trial and late-stage studies are testing single-dose and two-dose regimens. Phase 3 trial will enroll 60,000 people across 3 continents, at more than 200 sites. Phase 1/2a trials had positive interim results, published on Sep 25. J&J reported that 99% of the trial participants had developed neutralizing antibodies against coronavirus—although these participants were between the ages of 18 and 55. Most of the side effects were mild to moderate, such as fever, headache, fatigue, body aches and injection-site pain, and they had resolved within a couple of days. 15 individual over the ages of 65 were part of this analysis. However, the rate of adverse reactions in the older population were much lower than seen in the younger individuals. This could mean the immune response in the older adults may be weaker.

Overall, the good news so far is that a single dose of the J&J vaccine produced a strong immune response.  If this vaccine proves to be safe and efficacious in Phase 3, and the single-dose approach pans out well, then it will significantly simplify the distribution of this vaccine in comparison to others who are using a double-dose regimen.  So far, J&J vaccine is the only Phase 3 Covid-19 vaccine trial in the US evaluating a single-dose regimen. Many specialists believe protein subunit vaccines, such as the J&J vaccine, might be more attractive than the mRNA candidates.

Oct 17 Update

On October 12, Johnson and Johnson announced it is halting its Covid-19 vaccine trial to investigate an “unexplained illness” in a trial participant.  JNJ and an independent Data Safety Monitoring Board will review the case before the trial can resume. These trial pauses are expected and are normal standards of clinical studies ensuring that the ethical guardrails are working to provide utmost attention to safety. Out of 30,000 participants so far, half received the active vaccine (the real medicine) and the other half received the inactive control placebo (a harmless substance that has no effect of the medicine) so that the researchers can compare effectiveness between the two groups. Only the Data Safety Monitoring Board members will know whether the participant received the real vaccine or the control placebo. If he or she is in the control group, then the trial will likely lift its hold to restart quickly.

Nov 17 Update

The trial resumed eleven days later. Johnson and Johnson still expects to get results by the end of 2020. On Nov. 16, the company announced initiation of a second Phase 3 trial to evaluate the effects of two doses of their vaccine, instead of a single dose.

Nov 22 Update

On November 16, JNJ reported that it will initiate a 2nd phase 3 trial on two doses of their vaccine, instead of just one.

Jan 14 Update

On Jan 13, the New England Journal of Medicine published the interim results of phase 1/2a of the single-dose JNJ coronavirus vaccine, and reported that it is safe and appears to induce a promising immune response in both young and elderly volunteers. In the trial, the most common side effects include fever, fatigue, headache, muscle aches and pain at the injection site. Side effects were less common in the older age cohort, who received one dose, as well as a lower dose of the vaccine. JNJ will release its phase 3 trial data evaluating 45,000 volunteers later this month.

Novavax
(Vaccine: NVX-CoV2373

Novavax vaccines consist of proteins attached to microscopic particles.  Novavax started Phase 3 trial enrolling about 10,000 participants in the UK. A larger, 30,000-person Phase 3 trial launched in the United States on Dec. 28.

Upon successful completion of the trials, the company expects to deliver 100 million doses for use in the U.S. by the first quarter of 2021. In September Novavax signed an agreement with the Serum Institute of India to help manufacture ~2 billion doses a year. They also have agreements with the United Kingdom to deliver 60 million doses and Australia for 51 million doses.

Sources: Fierce Pharma, The NY Times Coronavirus Vaccine Tracker, CDC and other news media linked within text.

Vaxtherapy is NOT affiliated with any of the pharma/biotech companies working on COVID-19 vaccines. The purpose of this post is to provide education and awareness from a virologist’s independent perspective based on available facts and data.

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