COVID-19 vaccine trials: Live updates

COVID-19 vaccine trials: Live updates

  • 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 57 candidate vaccines on trial in 37 countries.
  • Today, there are 12 candidate vaccines in stage 3 clinical trials.
  • For general COVID-19 updates visit our live blog.

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.”READER SURVEYPlease take a quick 1-minute survey

Your answers will help us improve our experience. You’re the best!ANSWER OUR SURVEY

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.

Leave a reply