/COVID-19 vaccine trials: Live updates

COVID-19 vaccine trials: Live updates

Boxes containing the Moderna COVID-19 vaccine are prepared to be shipped at the McKesson distribution center on December 20, 2020 in Olive Branch, MississippShare on Pinterest
A worker prepares boxes containing the Moderna COVID-19 vaccine in Olive Branch, MS.
Pool/Getty Images
  • COVID-19 is a respiratory disease caused by the SARS-CoV-2 virus.
  • Researchers across the globe are working to develop a vaccine.
  • Currently, there are 60 candidate vaccines on trial in 41 countries.
  • Today, there are 15 candidate vaccines in stage 3 clinical trials.
  • So far, 3 vaccines have been approved.
  • For general COVID-19 updates visit our live blog.

12/21/2020 09:20 GMT — Low income countries lose out to wealthy countries

In a recent report, a coalition of scientists, activists, and international organizations warn that 90% of people in 67 low income and lower-middle income countries will not receive vaccinations against COVID-19 in 2021.

According to the People’s Vaccine Alliance, this is partly due to rich countries purchasing many times the number of doses of the vaccine necessary to vaccinate their populations. Anna Marriott, health policy manager for Oxfam, explains:

“No one should be blocked from getting a lifesaving vaccine because of the country they live in or the amount of money in their pocket. But unless something changes dramatically, billions of people around the world will not receive a safe and effective vaccine for COVID-19 for years to come.”

Read MNT’s coverage of the report here.

12/21/2020 09:05 GMT — US authorizes Moderna vaccine

The Food and Drug Administration (FDA) have given the Moderna vaccine emergency use authorization (EUA), making it the second vaccine with EUA in the United States. Already, the U.S. has agreed to purchase 200 million doses. Officials expect that healthcare professionals will give the first shots this morning.

On Friday, the FDA commissioner Stephen Hahn said that the move is “another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.”

As with the Pfizer-BioNTech vaccine, the Moderna offering is also an mRNA vaccine. However, the Moderna vaccine does not require ultra-cold storage during transportation, which will make it easier to supply to more remote and rural areas.

Read more here.

12/18/2020 11:05 GMT — How do mRNA vaccines work?

Both the Pfizer-BioNtech vaccine and the Moderna vaccine candidate utilize mRNA technology. In a recent article, Medical News Today took a deep dive into the science behind mRNA vaccines. We explain how they differ from other types of vaccines and discuss their stability and safety.

Read the feature here.

12/18/2020 10:20 GMT — Johnson & Johnson announce phase 3 clinical trial

Johnson & Johnson recently announced a multicountry phase 3 clinical trial of their COVID-19 vaccine candidate. The company have already enrolled around 45,000 participants and, if the vaccine proves safe and effective, they will look for emergency use authorization from the Food and Drug Administration (FDA) in February 2021.

Data from the trial, called ENSEMBLE, could be available by the end of January 2021.

In contrast to the Pfizer-BioNTech and Moderna vaccines, the Johnson & Johnson offering only requires one dose. However, in parallel to ENSEMBLE, the company are running a phase 3 clinical trial called ENSEMBLE 2, which is investigating a two-dose regimen of Janssen.

Read more here.

12/18/2020 09:14 GMT — Moderna vaccine nears approval

Yesterday, Food and Drink Administration (FDA) advisors endorsed the emergency use of Moderna’s vaccine. Although one expert abstained, the remaining 20 experts voted that the benefits of the COVID-19 vaccine outweighed the risks in people over 18. The FDA are expected to grant emergency use authorization today.

Because the Moderna vaccine does not need storing in ultra-cold freezers, it will be easier to ship to remote and rural areas. As with the Pfizer-BioNTech vaccine, the Moderna vaccine is based on mRNA technology and requires two shots around 4 weeks apart.

The expert who abstained was Dr. Michael Kurilla from the National Institutes of Health (NIH). He explained his reasoning: “I’m not convinced that for all of those age groups, the benefits do actually outweigh the risk. And I would prefer to see it more targeted towards people at high risk of serious and life threatening COVID disease.”

Alex Azar, Health and Human Services Secretary, advised that 5.9 million doses of the Moderna vaccine were already ready to be shipped across the United States.

Read more here.

12/17/2020 09:33 GMT — Guidance on mandatory vaccines for employees in the US

The Equal Employment Opportunity Commission (EEOC) have issued guidance for companies that are considering making the COVID-19 vaccine mandatory. They explain that employers must be prepared to exempt employees with disabilities and religious objections.

The EEOC also state that companies choosing not to administer the vaccine in the workplace can require employees to provide proof that they have been vaccinated without violating the Americans with Disabilities Act.

However, the law only allows employers to ask workers why they have refused the vaccine if the information is “job-related and consistent with business necessity.”

Also, if an employee refuses vaccination due to religious or medical reasons, the employee cannot be excluded from the workplace unless the employer cannot find a way to reasonably accommodate the individual.

Read more here

12/17/2020 09:16 GMT — Pfizer vaccine temperature concerns

The Pfizer-BioNTech vaccine must be stored at -94°F (-70°C). Yesterday, a number of batches in California dipped to lower than -112°F (-80°C). Pfizer are replacing the doses, and officials are investigating whether or not these lower temperatures would impact the vaccine.

Find more information here.

12/16/2020 09:16 GMT — Vaccine developed by British American Tobacco (BAT) approved for human trials in US

Yesterday, the U.S. health regulator approved a vaccine developed by BAT for human trials. The vaccine, developed by BAT’s biotech subsidiary, Kentucky BioProcessing, derives from tobacco leaves. Enrollment for the study is likely to begin shortly. BAT expect clinical trials to start in late June 2021. 

According to a BAT news release from April, “The vaccine in development uses BAT’s proprietary, fast-growing tobacco plant technology, which has several advantages over conventional vaccine production technology.“

According to the news release, using tobacco plants “is potentially safer given that tobacco plants can’t host pathogens, which cause human disease.” They also explain that their technology “has the potential to deliver an effective immune response in a single dose.“

Read more here.

12/16/2020 09:01 GMT — How have we developed vaccines so quickly?

As countries begin distributing vaccines, Medical News Today spoke with a number of medical experts to learn how scientists created COVID-19 vaccines so swiftly without compromising safety.

With rapid research development, some people may be concerned that the vaccine was rushed, and with these concerns comes vaccine hesitancy. Dr. Sam Sun is the director of inDemic Foundation, a nonprofit organization that provides information about COVID-19, and a chief resident at Baylor College of Medicine, in Houston, TX.

He explained that transparency throughout the vaccine process will be key to debunking misinformation and building the public’s trust.

Read the feature here.

12/15/2020 14:46 GMT — Moderna vaccine draws closer to emergency use authorization

According to Food and Drug Administration’s reviewers, the Moderna vaccine is 95% effective. Importantly, the group did not raise any safety concerns. The FDA released the data in a 54-page document earlier today. The organization will discuss the findings in a vaccine panel meeting on Thursday. 

If the FDA give the vaccine emergency use authorization, the first shipments could be sent before the weekend. 

Like the Pfizer-BioNTech, which received emergency use authorization a few days ago, the Moderna vaccine also requires two shots to achieve full protection from the virus.

Unlike the Pfizer-BioNTech vaccine, Moderna’s offering does not require ultra-cold storage: it can be kept at temperatures similar to a standard freezer. 

Read more here.

12/15/2020 10:58 GMT — How do COVID-19 vaccines compare with other existing vaccines? 

In a recent feature, Medical News Today compare the COVID-19 frontrunner vaccines to other vaccines, such as the flu shot, and look at their safety considerations. We also explain the difference between effectiveness and efficacy. 

Read the full article here.

12/14/2020 15:42 GMT — Canada starts vaccination rollout today

Over the weekend, 30,000 doses of the Pfizer–BioNTech vaccine arrived in Canada. Quebec and Ontario are set to begin vaccinations today. In Quebec, they plan to prioritize care homes, where 80% of COVID-19 deaths have occurred.

Read more here.

12/14/2020 15:24 GMT — First New York healthcare worker receives vaccine

Today, Sandra Lindsay became the first healthcare worker to receive the Pfizer–BioNTech COVID-19 vaccine in New York. The intensive care unit nurse received the vaccine at Long Island Jewish Medical Center in Queens, one of the epicenters of COVID-19 earlier this year.

Lindsay says: “I feel hopeful today, relieved. I feel like healing is coming. I hope this marks the beginning of the end of a very painful time in our history. I want to instill public confidence that the vaccine is safe.”

Read more here.

12/14/2020 09:27 GMT — FDA issue emergency use authorization for COVID-19 vaccine

On Friday, the Food and Drug Administration (FDA) issued emergency use authorization for the Pfizer-BioNTech vaccine. The FDA concluded that the “potential benefits [of the vaccine] outweigh the known and potential risks […].” The first shipments of the vaccine left FedEx and UPS facilities in Tennessee and Kentucky yesterday.

In a press release, FDA Commissioner Dr. Stephen M. Hahn says, “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”

He continues: “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

Read the FDA’s full news release here.

12/11/2020 09:03 GMT — Spotlight on 3 vaccine front-runners

In a Special Feature, Medical News Today provide an overview of the latest advancements in vaccine development. We focus on three leading vaccine candidates that have been approved or are nearing approval: the Oxford/AstraZeneca candidate, the Pfizer/BioNTech candidate, and the Moderna candidate.

Read the full feature here and watch our video summary:

12/11/2020 08:57 GMT — FDA experts recommend Pfizer-BioNtech vaccine

This week, a panel of experts who advise the Food and Drug Administration (FDA) recommended that the body should give the Pfizer-BioNTech COVID-19 vaccine emergency approval. The committee voted 17–4 that the benefits of the vaccine outweigh the risks for people aged 16 years and older. 

Although we do not know why four voted against the decision, some of the experts were uncomfortable with including people under the age of 18 years.

The vaccine has already received approval in the United Kingdom, Canada, Bahrain, and Saudi Arabia.

The FDA’s vaccine chief will decide whether or not to formally approve the vaccine in the next few days. After the meeting, U.S. health secretary Alex Azar said, “We could then have a vaccine within days, and be administering it to the most vulnerable by next week.”

According to Operation Warp Speed, vaccine deliveries will begin within 24 hours of official approval. Pfizer will have 6.4 million doses ready for the U.S. by late December, which is enough to vaccinate 3.2 million people, or almost 1% of the U.S. population.

Healthcare workers are likely to be vaccinated first. People who are not at high risk will likely have to wait until spring to be vaccinated. 

Read more here.

12/10/2020 09:18 GMT — Two allergic reactions to COVID-19 vaccine reported in UK on first day of roll-out

On Wednesday, the United Kingdom began rolling out the Pfizer BioNTech COVID-19 vaccine. According to the head of Britain’s medicine regulator, two individuals had allergic reactions shortly after receiving it. Both have since recovered.

The two people are National Health Service (NHS) employees with histories of allergic reactions, and they carry epinephrine auto-injectors (EpiPens). Reactions to vaccines, including to the annual flu vaccine, are uncommon, but they do occur.

According to Prof. Peter Openshaw, an expert in immunology at Imperial College London, “The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.”

In a statement, Pfizer write: “As a precautionary measure, the [Medicines and Healthcare products Regulatory Agency (MHRA)] has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.”

They continue: “In the pivotal phase 3 clinical trial, this vaccine was generally well-tolerated, with no serious safety concerns reported by the independent data monitoring committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”

Prof. Saad Shakir, director of the Drug Safety Research Unit, in the U.K., observes: “The summary of product characteristics [SmPC] for the Pfizer vaccine includes a statement saying that this vaccine should not be given to people with hypersensitivity to active substances. A list of active substances was included in the SmPC, but this was not specific.”

He concludes: “It seems that the advice now has been upgraded so that people should not be vaccinated with this vaccine if they have a history of allergic reactions severe enough to require them to use an EpiPen […] when they get a severe allergic reaction. This is the correct risk minimization action.”

Read more here.

12/09/2020 09:21 GMT — ‘Oxford’ vaccine: Results from phase 3 trial

Yesterday, The Lancet published the results of phase 3 clinical trials investigating AstraZeneca’s so-called Oxford vaccine. The study involved people in the United Kingdom, Brazil, and South Africa. Overall, the results show that the vaccine candidate protects against the symptomatic disease in 70% of cases.

Although 70% efficacy is lower than efficacy of some of the other vaccine candidates, the researchers found that when participants received a half dose followed by a whole dose, the vaccine was 90% effective. However, the researchers only gave this regimen to a relatively small group — 1,367 participants — and no one in this group was over 55.

When participants received two full doses, the vaccine was 62% effective.

The Oxford vaccine uses a chimpanzee adenovirus viral vector that contains the genetic sequence of the SARS-CoV-2 spike protein. The viral vector enters human cells, where it begins to express the spike protein.

The cell then mounts an immune response against the spike protein, priming it to respond to SARS-CoV-2 in the future.

The phase 3 results also show that the Oxford vaccine has an acceptable safety profile. Severe adverse events occurred in 168 participants. Of these, three events were possibly due to vaccination. One occurred in the experimental group, one in the control group. The third participant is in a group that has not been unblinded. All three have recovered or are recovering.

One of the study authors, Dr. Merryn Voysey from the Oxford University, U.K., says, “The results presented in this report provide the key findings from our first interim analysis. In future analyses, with more data included as it becomes available, we will investigate differences in key subgroups, such as older adults, various ethnicities, doses, timing of booster vaccines, and we will determine which immune responses equate to protection from infection or disease.”

Dr. Voysey continues: “In order to assess vaccine efficacy, we need to have a sufficient number of COVID-19 cases among participants to indicate that the vaccine is protecting them from disease. Since recruitment of older adults started later than in younger adults, there has been less follow-up time for these cohorts and less time to accrue COVID-19 cases. This means we have to wait longer to have sufficient data to provide good vaccine efficacy estimates in smaller subgroups.”

Read the full paper here.

12/09/2020 09:07 GMT — Pfizer vaccine closer to authorization in US

Last month, Pfizer and BioNTech announced that their vaccine candidate was 95% effective against COVID-19. They are currently working with the Food and Drug Administration (FDA) to secure approval for emergency use. Yesterday, the FDA released documents declaring no issues with safety or efficacy.

The documents were released in advance of a meeting on Thursday, at which the FDA will speak with outside experts to discuss whether to give the vaccine to people over 16.

Although the FDA tend to follow the advice of their advisory panels, they are not obliged to. It is not clear how long the FDA will take to make their decision, but states are beginning preparations for vaccine deliveries in mid-December. 

The Pfizer-BioNTech vaccine is currently being rolled out across the United Kingdom.

Read more here.

12/08/2020 09:46 GMT — UK begins mass vaccinations

Today, the United Kingdom became the first Western nation to begin mass vaccinations. Health Secretary Matt Hancock dubbed the day “V-day.” In Coventry, 90-year-old Margaret Keenan became the first person to receive the vaccine outside of clinical trials.

According to Simon Stevens, the head of the National Health Service (NHS), “The deployment of this vaccine marks a decisive turning point in the battle with the pandemic.”

The vaccine, which was developed by Pfizer and BioNTech, must be kept at -94°F (-70°C) and can only last 5 days in a domestic fridge. This may prove to be a challenging logistical issue, even in a relatively small country. This problem of maintaining the temperature would be compounded in larger countries and those with warmer climates. 

A vaccine candidate developed by Oxford University and AstraZeneca is easier to store. The U.K.’s Chief Scientific Adviser, Patrick Vallance, hopes it will meet regulatory approval within the next 2 weeks.

The U.K. has ordered enough of the Pfizer–BioNTech vaccine for 20 million people. Around 800,000 doses will be available within the first 7 days, and Hancock expects millions to be vaccinated by the end of the year. In all, the U.K. has purchased 357 million doses of seven different vaccine candidates.

Read more here.

12/07/2020 09:51 GMT — ‘Clear, balanced information’ important for vaccine uptake

In a recent editorial, David Phizackerley, the deputy editor of the journal Drug and Therapeutics Bulletin, argues that clear and balanced information on the efficacy and safety of the COVID-19 vaccines is important for ensuring their broad uptake.

In the editorial, Phizackerley explains that “balanced information on vaccination risks and benefits by healthcare professionals has been shown to have an impact on uptake.”

He believes that information should be tailored to both different age groups and people with different vulnerabilities to the disease.

He concludes, “Such information will be essential to support national vaccination programs and to help counter rumors, fake news, unsubstantiated scare stories, and overinflated claims of success.”

Read MNT’s full coverage of the editorial here.

12/07/2020 09:46 GMT — Adapted yellow fever vaccine may protect against COVID-19

A new study finds that a genetically altered yellow fever vaccine is highly effective in preventing SARS-CoV-2 infection in animals. If it passes clinical trials, the vaccine might have some advantages over other SARS-CoV-2 vaccines. For instance, it provided protection after just one shot.

The results of the study appear in the journal Nature and as a preprint. The scientists tested the modified yellow fever vaccine in hamsters and monkeys. Prof. Johan Neyts, one of the study leads, believes that the vaccine may provide long-term protection. He says:

“It could, therefore, be an ideal candidate for repeat vaccinations when immunity decreases in people who have received one of the first-generation vaccines.”

Only clinical trials can reveal whether the vaccine is safe and effective in humans. However, the researchers are optimistic that it will provide rapid, strong immunity after a single dose.

Read MNT’s full coverage of the study here.

12/04/2020 10:15 GMT — Three former presidents willing to take the vaccine publicly

In an attempt to increase public confidence, three former presidents — George W. Bush, Bill Clinton, and Barack Obama — have all stated that they would be prepared to take the COVID-19 vaccine publicly once it receives approval.

During a recent interview, Obama said: “I promise you that when it’s been made for people who are less at risk, I will be taking it. […] I may end up taking it on TV or having it filmed, just so that people know that I trust this science.”

In a statement on Thursday, Clinton’s spokesperson Angel Ureña explained that the former president would take the vaccine “in a public setting if it will help urge all Americans to do the same.”

Talking with CNN, Bush’s chief of staff Freddy Ford said that Bush “wants to do what he can to help encourage his fellow citizens to get vaccinated.” He explained that once the vaccines are ready and priority populations have received the vaccination, “Bush will get in line for his and will gladly do so on camera.”

Read more here.

12/04/2020 09:40 GMT — Dr. Fauci apologizes for claiming UK rushed decision

Earlier this week, Dr. Anthony S. Fauci, sparked controversy when he claimed that the United Kingdom had not acted as carefully as the Food and Drug Administration (FDA) when it licensed its first COVID-19 vaccine. Yesterday, he apologized and said he has “great faith” in the U.K. regulators.

Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), explained that he had not phrased his thoughts correctly earlier in the week and that the way in which U.K. regulators work is different from, but not better than, the FDA’s.

Talking with the BBC, he said: “Our process is one that takes more time than it takes in the U.K. And that’s just the reality. I did not mean to imply any sloppiness, even though it came out that way.”

Read more here.

12/03/2020 09:31 GMT — Russia plans large-scale COVID-19 vaccination plan

Yesterday, Russian President Vladimir Putin announced a large-scale vaccination program to begin next week. Doctors and teachers will be first in line for the vaccine. Experts are concerned as the Sputnik V vaccine is yet to complete advanced clinical trials for safety.

According to Putin, 2 million doses of the Sputnik V vaccine “has been produced or will have been produced in the next few days.” He continued:

“This gives us the opportunity to start if not mass, but large-scale vaccination, and of course, as we agreed, first of all of the two risk groups — doctors and teachers,” He called on Deputy Prime Minister Tatyana Golikova to “organize the work in such a way so that large-scale vaccination starts by the end of next week.”

Golikova explained that the vaccine will be free of charge and voluntary. 

Although clinical trials are still ongoing, certain at-risk groups and government officials have already received the vaccine. On Wednesday, Health Minister Mikhail Murashko claimed that more than 100,000 people in Russia had already received the vaccine.

Read more about the Russian vaccine here.

12/03/2020 09:16 GMT — AstraZeneca’s US vaccine trial results due early 2021

On Wednesday, the chief adviser for the United States government’s Operation Warp Speed program announced that results from AstraZeneca’s U.S. vaccine trials should be available in January. If the results are encouraging, they will likely file for an emergency authorization from the Food and Drug Administration (FDA).

United Kingdom researchers helped develop AstraZeneca’s so-called Oxford vaccine. Recent results from trials in the U.K. and Brazil raised questions. 

Overall, the vaccine was around 70% effective. However, due to an error, scientists gave a group of participants a half dose followed by a full dose, rather than two full doses. In this relatively small group of participants, the vaccine was 90% effective.

Because of the discrepancies, Operation Warp Speed chief adviser Moncef Slaoui believes that the data from the U.K. and Brazil research is not strong enough to receive emergency use authorization from the FDA.

He said, “Unless there is a very clear explanation based on facts and data of what’s behind those two numbers, it’s very likely that package would not be sufficient for [FDA] approval.”

However, Slaoui expects that, by the end of January, “data will become available and potentially an emergency use authorization could be filed.”

Read more here.

12/02/2020 08:57 GMT — UK licenses vaccine against COVID-19 

The Medicines and Healthcare products Regulatory Authority (MHRA) in the United Kingdom have authorized the Pfizer/BioNTech vaccine for emergency use. The U.K. has already purchased 40 million doses of the vaccine, and the first 10 million doses should arrive this month.

Chairman and chief executive officer of Pfizer, Albert Bourla, says, “Today’s emergency use authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.”

Pfizer and BioNTech combined believe that they can produce and supply 50 million vaccine doses throughout 2020 and up to 1.3 billion by the end of 2021.

Although the vaccine needs to be kept at -94°F (-70°C), the pharmaceutical companies explain that it can be stored in a standard fridge at 35–46°F (2–8°C) for 5 days.

The first doses are likely to be given to residents and healthcare workers in U.K. care homes. Next, the vaccine will be provided to people over 80 and National Health Service (NHS) staff

Find more details here.

12/02/2020 08:49 GMT — The FDA move toward vaccine approval

On Tuesday, Food and Drug Administration (FDA) Commissioner Stephen Hahn said it was possible that the FDA would approve Pfizer’s experimental vaccine before the end of the year. However, in the ABC News interview, he explained that “it’s hard to predict. […] We need everything to fall into place.”

Next week, Donald Trump, who is keen to leave his mark on the vaccine process, will be meeting with industry and government leaders to discuss the vaccine. In a statement, White House spokesman Brian Morgenstern said: 

“President Trump’s Operation Warp Speed continues rapidly advancing toward a safe and effective coronavirus vaccine five times faster than any other vaccine in history.”

Read more about the vaccine push in the United States here.

11/30/2020 14:57 GMT — Moderna apply for approval for mRNA vaccine candidate in the US and Europe

Today, Moderna announced the completion of their phase 3 clinical trial primary efficacy analysis. The vaccine candidate is 94.1% effective against COVID-19 and 100% effective against severe COVID-19. The company will apply today for emergency use approval in the United States. 

In addition, it will also apply to the European Medicines Agency for conditional marketing authorization.

In a press release, Moderna highlighted that 196 people enrolled in their 30,000-participant trial have now had COVID-19. Of them, 11 were in the group that had received the vaccine. 

There were 30 cases of severe COVID-19, all in the placebo group. One person in this group died. 

The 196 cases of COVID-19 in the study occurred among diverse participants, including older adults and those from minority ethnic groups.

The company stressed that they will submit the results of the study to a peer reviewed journal. 

Read more updates about the novel coronavirus here.

11/26/2020 10:26 GMT — Scientists in the Netherlands plan ‘human challenge’ vaccine study

Scientists from Leiden University Medical Center (LUMC) in the Netherlands are hoping to deliberately transmit SARS-CoV-2 to participants to test vaccine efficacy. Already, 240 people have stepped forward to participate in the “human challenge” trial.

The trial has the support of 1Day Sooner, a nonprofit organization advocating for COVID-19 human challenge trial volunteers. In a press release, they write, “These studies may be essential to developing enough proven vaccines to vaccinate the whole world in 2021, not just the wealthy.”

As Meta Roestenberg, a researcher at LUMC who will be involved in the trial, explains: “Such a study can be important in answering questions we still have about COVID-19: How long will you stay protected after an infection? How do we compare vaccines? How many antibodies are you producing? How much virus load causes an infection in which cases? You can answer such questions with this research.”

Find more live COVID-19 updates here.

11/23/2020 09:52 GMT — AstraZeneca’s ‘Oxford’ vaccine 70% effective

According to a recent press release, the experimental COVID-19 vaccine developed by AstraZeneca and Oxford University prevents just over 70% of people from developing COVID-19. Although this is lower than the Pfizer and Moderna vaccines, using a different dosing regimen may increase the protection to 90%.

The recent announcement is based on data from 24,000 participants in three countries. Importantly, the Oxford vaccine is more cost effective to produce and easier to store and transport than the Pfizer and Moderna vaccines.

The so-called Oxford vaccine trial tested two dosing regimens:

  • two full doses, which provided 62% protection
  • one half dose followed by one full dose, which provided 90% protection

Prof. Andrew Pollard, the director of the Oxford Vaccine Group, explains:

“These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective, and if this dosing [regimen] is used, more people could be vaccinated with planned vaccine supply.”

Dr. Stephen Griffin, an associate professor in the School of Medicine at the University of Leeds, U.K., says:

“This is yet more excellent news and should be considered tremendously exciting. The Oxford vaccine, as for the others we’ve heard about recently, is capable of generating 90% protection against COVID-19. Given the favorable stability seen for this vaccine, it has great potential to be delivered across the globe, achieving huge public health benefits.”

Dr. Griffin was not involved with the study.

Read more here.

11/19/2020 10:31 GMT — Pfizer and BioNTech COVID-19 candidate vaccine is 95% effective

In a recent press release, Pfizer and BioNTech announced the results from their phase 3 clinical trial. According to the results, the experimental vaccine is 95% effective. These results build on preliminary results that were announced last week.

According to the new press release, “[e]fficacy was consistent across age, gender, race, and ethnicity demographics” and in people over 65. 

The study included 43,000 participants and the scientists identified no significant safety concerns. The researchers have dubbed their mRNA vaccine candidate BNT162.

According to the press release, “[t]he companies expect to produce, globally, up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.”

Read more here

11/18/2020 09:18 GMT — Hopeful preliminary results from Chinese vaccine trials

Yesterday, The Lancet Infectious Diseases published the results of a Phase 1/2 clinical trial on a vaccine candidate designed in China. The study included more than 700 participantsaged 18–59. The vaccine, which is called CoronaVac, appears to be safe and elicit an immune response.

The researchers gave the participants two doses of the vaccine 2 weeks apart. Within 4 weeks of the initial dose, they detected a robust antibody response.

It is worth noting that this study was not designed to test how effective the vaccine is. Instead, it assessed the immune response and the vaccine’s safety. Ongoing phase 3 trials are studying CoronaVac’s efficacy.

The results leave some questions unanswered; for instance, the recent study did not assess T-cell activity. The authors are addressing this question in the phase 3 trials.

Similarly, scientists will need to carry out further research to understand whether the vaccine is effective over months and years. Additionally, the recent study only recruited healthy adults without existing health conditions.

One of the authors, Dr. Gang Zeng from Sinovac Biotech explains, “CoronaVac is one of many COVID-19 vaccine candidates that are being explored in parallel. There are a multitude of different vaccine technologies under investigation, each with their own advantages and disadvantages.”

He continues: “CoronaVac could be an attractive option because it can be stored in a standard refrigerator between 2°C and 8°C [35.6°F–46.4°F], which is typical for many existing vaccines, including [that for the] flu. The vaccine may also remain stable for up to 3 years in storage, which would offer some advantages for distribution to regions where access to refrigeration is challenging. However, data from phase 3 studies will be crucial before any recommendations about the potential uses of CoronaVac can be made.”

Read the full study here.

11/16/2020 13:15 GMT — Moderna’s experimental vaccine almost 95% effective

Today, Moderna released the latest findings from their COVE study. The research focuses on an experimental vaccine known as mRNA-1273. According to their press release, the “[p]hase 3 study met statistical criteria with a vaccine efficacy of 94.5%.” The U.S. study included more than 30,000 participants.

Explaining the results, the press release states: 

“This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% […]. A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.”

The company plan to submit the new findings to a peer-reviewed journal for further scrutiny.

Speaking about the recent results, Prof. Peter Openshaw, professor of experimental medicine at Imperial College London, says, “This news from Moderna is tremendously exciting and considerably boosts optimism that we will have a choice of good vaccines in the next few months.”

However, he remains cautious: “We need more complete details than we have in this press release, but this announcement adds to the general feeling of optimism about vaccines for Covid-19. What we still don’t know is how long any protective immunity may last. For that, we will need to wait.”

Prof. Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine says:

“This announcement from Moderna is a further encouragement that vaccines will be found to not only have an acceptable efficacy but an efficacy that is much greater than we had anticipated. […] Although they reported efficacy being over 94%, there is statistical uncertainty in this; but based on these data, the likely efficacy will be better than 85%, which would be greater than most scientists would have expected.”

Read more about Moderna’s experimental vaccine here.

11/13/2020 15:00 GMT — Dr. Fauci: Another vaccine ‘literally on the threshold of being announced’

In a live webinar hosted by the British think tank Chatham House, Dr. Anthony Fauci explained that, in addition to the Pfizer vaccine, another one is “literally on the threshold of being announced.”

The news comes soon after Pfizer/BioNTech reported their vaccine candidate has 90% effectiveness. The additional vaccine that Dr. Fauci refers to is under development by Moderna therapeutics and is almost identical to the Pfizer one.

“The cavalry is coming, but don’t put your weapons down,” Dr. Fauci said, urging people to continue to follow and “double down” on the public health measures against COVID-19.

Watch the recording of the webinar in full here.

11/12/2020 09:30 GMT — More vaccine updates

Russia has announced that the first phase 3 trial interim analysis of their Sputnik V COVID-19 vaccine showed 92% efficiency. However, many questions remain. Meanwhile, Moderna announced that they would be submitting the first set of their phase 3 trial vaccine data for analysis soon.

This week saw announcements from three of the companies who are currently running phase 3 trials of their vaccine candidates. 

On Monday, Pfizer and BioNTech announced that their experimental mRNA vaccine was 90% effective. This was based on an interim analysis of 94 cases of COVID-19.

Yesterday, the Gamaleya National Center of Epidemiology and Microbiology announced that their interim analysis, based on 20 confirmed cases of COVID-19, showed a 92% efficiency. 

However, neither Pfizer nor the Russian team have shared their data, which leaves many questions unanswered.

Moderna have followed suit with a press release explaining that they had seen an increase of COVID-19 cases across all of their phase 3 trial study sites in the last week. The company have now collected enough data to prepare this for the first interim analysis.

Read more detail on the different types of vaccine candidates in development here.

11/10/2020 09:21 GMT — COVID-19 vaccines: What PAHO experts want you to know

With 47 COVID-19 vaccine candidates currently in testing, it is no wonder that myths and rumors are circulating. Recently, experts from the Pan American Health Organization (PAHO) addressed some of these confusions in a webinar.

Read MNT’s full coverage of the webinar here.

11/09/2020 13:06 GMT — Pfizer and BioNTech announce preliminary vaccine results

Today, Pfizer and BioNTech announced that their COVID-19 vaccine candidate appears to be effective and safe, according to preliminary data. They explain that the vaccine was “more than 90% effective” in preventing the disease in people who received two doses of the vaccine 3 weeks apart. 

They showed that protection against COVID-19 begins 1 week after the second dose is administered.

It is important to reiterate that these are preliminary findings. However, so far, they include data from 43,538 people in six countries. The press release also explains that “no serious safety concerns have been observed.”

To date, the analysis includes data from 94 people with COVID-19. The study will continue until there are 164 confirmed cases.

Once the required safety milestone is reached, toward the end of November, the companies plan to submit the vaccine for Emergency Use Authorization to the Food and Drug Administration (FDA).

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science, and a global collaborative effort,” said Prof. Ugur Sahin, co-founder and CEO of BioNTech.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

Read more here.

11/02/2020 10:28 GMT — Surgeon General predicts vaccine by the end of 2020

During a recent lecture, Dr. Jerome Adams, the U.S. Surgeon General, said he has “a high degree of confidence” that a vaccine will be successful because it is “the most scrutinized vaccine of all time.” He believes it will be ready by the end of 2020.

During the lecture — part of the Department of Anesthesiology and Perioperative Medicine’s Grand Rounds series — he promoted the “three Ws” — wearing masks, washing hands, and watching your distance from other people.

“We know what works to keep people safe,” he said. “When you look at New York, they were the worst in the world for COVID-19, and they were able to drive their transmission rates down to less than 1%. They didn’t have a vaccine; they did it with the three Ws.”

Read more here.

10/30/2020 09:09 GMT — Vaccine may be ready by January 2021

According to Dr. Anthony Fauci, a vaccine may be available by early next year. First, it would be provided to high risk individuals. Based on projections from Moderna and Pfizer, Dr. Fauci expects that we will know “sometime in December whether or not we have a safe and effective vaccine.” 

In July, both Moderna and Pfizer began late stage trials involving tens of thousands of participants. However, Dr. Fauci also reminds us that even once a vaccine is ready, a return to “normal” will not be possible “until the end of 2021, at least.”

Read more here.

10/26/2020 10:27 GMT — AstraZeneca’s ‘Oxford vaccine’ moves forward

An experimental vaccine, developed by scientists at the University of Oxford in the United Kingdom and AstraZeneca, recently passed another milestone. In July, the team announced that the experimental drug produced “robust immune responses” in adults. Today, they report that the experimental vaccine responds similarly in older adults and young people.

The scientists are yet to publish their findings in a peer-reviewed journal, but Prof. John Ball from the University of Nottingham, U.K., who was not involved in the study, is hopeful. He told the Financial Times:

“If what they’ve got is data that show the vaccine generates good immunity, as measured in the lab, in the age group over 55, and that also includes good responses in people who are even older than that, I think that’s a promising sign.”

However, he remains realistic, explaining that, “ultimately, it’s whether the vaccine protects against serious disease that’s crucial and we will only know that from phase 3 trials.”

Read more here.

10/23/2020 09:13 GMT — What will COVID-19 vaccine trials tell us? Less than some may think

What will COVID-19 vaccine candidate trials tell us? Not whether they will prevent deaths or serious illness, according to a new article in the BMJ. The feature highlights precisely what these trials do and do not set out to answer.

Read MNT’s full write up here.

10/21/2020 08:58 GMT — UK scientists plan to infect participants with SARS-CoV-2

Scientists in the United Kingdom are planning to infect young and healthy volunteers with SARS-CoV-2. The U.K. government will spend $43.5 million on these human challenge trials. If regulators and the ethics committee approve, they will begin early in 2021.

London’s Great Ormond Street Hospital plan to manufacture the virus, while Imperial College London will run the research. The trials will also involve hVIVO, a company that provides “viral challenge studies and laboratory services;” and the Royal Free London NHS Foundation Trust.

Involving up to 90 participants, the scientists plan to work out the minimum amount of virus sufficient to induce COVID-19.

According to Imperial College scientist Chris Chiu, this work will improve our understanding of SARS-CoV-2 and accelerate the search for better treatments and vaccines.

Speaking about the ethical considerations, a spokesperson from the World Health Organization (WHO) said:

“What is critical is that if people are considering this, an ethics committee must oversee this and the volunteers must have full consent. And they must select the volunteers to minimize their risk.”

Read more about COVID-19 research here.

10/16/2020 09:25 GMT — Russia approves a second vaccine

Last month, Russia announced the approval of a COVID-19 vaccine known as Sputnik V. This week, President Vladimir Putin announced the approval of another vaccine, which is called EpiVacCorona. As with the first, scientists have not yet put the experimental vaccine through phase 3 trials.

The vaccine was developed by scientists at the State Virology and Biotechnology Center, known as Vektor, in Novosibirsk. According to The Moscow Times:

“Early trials on 100 volunteers were said to have been successful.”

In a televised news conference, Putin explained that researchers had given the vaccine to Deputy Prime Minister Tatyana Golikova and the head of Russia’s consumer safety watchdog, Anna Popova, as part of ongoing trials. During the briefing, they explained that:

“Early trials on 100 volunteers were said to have been successful.”

As with Sputnik V, experts are likely to view the new vaccine with caution. Vaccines must be rigorously investigated before they can be used widely, and it is crucial to test their efficacy and safety in a large group of people.

Sputnik V is a vector vaccine, based on a human adenovirus, while EpiVacCorona is an antigen-based vaccine.

During the briefing, Golikova also announced that a third vaccine would be approved sometime toward the end of 2020x.

Read more here.

10/13/2020 10:35 GMT — Johnson & Johnson pause vaccine trial

In a statement, Johnson & Johnson announced they had paused their experimental vaccine trial “due to an unexplained illness in a study participant.” The participant’s illness is now under review with an independent safety board and the company’s clinical and safety physicians. 

The Janssen COVID-19 vaccine is part of the Operation Warp Speed program.

In the press release, Johnson & Johnson explain that serious adverse events are “not uncommon in clinical trials,” especially when a study has recruited large numbers of participants. To date, the company has not released any further information about the participant’s illness.

Find more live updates here.

09/24/2020 09:33 GMT — Most people in the United States could be vaccinated by July next year

Despite promising candidates, there is still no vaccine for COVID-19. However, according to Robert Redfield — the head of the Centers for Disease Control and Prevention (CDC) — the “entire American public [could be] completely vaccinated” by July. He estimates that 700 million doses will be available by April.

Read more here.

9/15/2020 09:58 GMT — Chinese vaccine ready by November?

According to officials in China, a COVID-19 vaccine could be ready by the end of November. Scientists are currently testing four candidate vaccines in late-stage clinical trials, and three of these have already been offered to frontline staff.

According to Guizhen Wu, the chief biosafety expert at China’s Centers for Disease Control and Prevention (CDC), phase 3 clinical trials are going well.

Read more here.

09/10/2020 09:18 GMT — Promising results for Russian vaccine

A new paper in The Lancet outlines the findings of two early phase clinical trials of the Russian vaccine known as Sputnik V. According to the authors, the vaccine “has a good safety profile and induced strong humoral and cellular immune responses in participants.”

It is worth noting, though, that the trials were designed to assess the safety and immunogenicity of the vaccine, not whether it can prevent COVID-19. Senior author Prof. Alexander Gintsburg explains the next steps:

“The phase 3 clinical trial of our vaccine was approved on 26 August, 2020. It is planned to include 40,000 volunteers from different age and risk groups and will be undertaken with constant monitoring of volunteers through an online application.”

Read MNT’s full coverage of the vaccine trial here.

09/14/2020 10:53 GMT — AstraZeneca resume vaccine trial

Last week, AstraZeneca paused a trial investigating an experimental vaccine. The move came following an illness in one participant. Following a review, the scientists are resuming the trial. The World Health Organization (WHO) have described this vaccine as a leading candidate.

In a recent statement, AstraZeneca state, “The independent review process has concluded, and following the recommendations of both the independent safety review committee and the U.K. regulator, the [Medicines and Healthcare products Regulatory Agency], the trials will recommence in the U.K.”

Read more about the clinical trial here.

09/09/2020 08:32 GMT — AstraZeneca’s COVID-19 vaccine trials halted

According to AstraZeneca Plc., they paused a large-scale clinical trial of an experimental vaccine because one participant developed an unexplained illness. The World Health Organization (WHO) had described this vaccine, developed at the University of Oxford in the United Kingdom, as a leading candidate.

AstraZeneca has halted trials while an independent committee reviews the safety data. In a statement, the company explain: “This is a routine action, which has to happen whenever there is a potentially unexplained illness in one of our trials.”

Although AstraZeneca has not disclosed the nature of the participant’s illness, doctors expect the individual to recover. At this point, it is not clear whether the vaccine was directly responsible for the condition.

Read more here.

09/02/2020 09:59 GMT — Third US vaccine reaches final trial stages

Today, AstraZeneca announced that their experimental vaccine had entered the final stage of testing. The upcoming study will involve up to 30,000 people in Brazil, the United Kingdom, and South Africa. The vaccine was developed at the University of Oxford in the U.K.

Read more here.

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