BRASILIA (Reuters) – Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said that the volunteer was Brazilian.
Since then, discussion has faded somewhat, due in part to the relentless messaging from President Trump and others about the coming vaccines. But as the leading western vaccine projects prepare to apply for emergency use from the FDA as soon as November or December, the World Economic Forum, the same supranational organization that organizes the annual forum in Davos, is taking the lead in testing a global standard to communicate that an individual hasn’t been infected with COVID-19.
The project to develop an international standard to communicate whether travelers have been infected with COVID-19 called the CommonPass system is being led by Paul Meyer, the CEO of the Commons Project, a Swiss non-profit financed by the Rockefeller Foundation. Meyer insists countries are looking for better ways to “thoughtfully reopen” their borders as European countries start cutting down intra-EU travel once again.
Right now, travelers’ COVID-19 test results are frequently printed out, with the results often obtained from unknown or uncertified labs.
With CommonPass, travelers would take a test at a certified lab, then the results would be uploaded to their phone. Then they would complete any other health-related questionnaires required by the country to which they’re traveling. Before boarding, airlines can use CP to check whether travelers have met the entry requirements. This can be done by simply scanning a QR code generated by the app.
Even after the COVID-19 pandemic ends, these ‘health passports’ could be used to offer evidence that a traveler has been vaccinated – not just for COVID-19, but for any other diseases.
And even once vaccines are widely available, the world will need a system for patients to prove that they have received the vaccine. Some countries might only allow travelers to enter if they have received a specific vaccine.
“It’s hard to do that,” he told the Guardian. “It requires being able to assess the health of incoming travellers…Hopefully, we’ll soon start to see some vaccines come on to the market, but there is not going to be just one vaccine.”
“Some countries are going to probably say, ‘OK, I want to see documentation you’ve gotten one of these vaccines, but not one of those vaccines.'”
Social media companies and mainstream media outlets are on a crusade, censoring anyone who challenges the “official” science and narrative behind the COVID-19 virus. It was only last week when Twitter removed New York Post’s bombshell stories about Hunter Biden. Then later in the week, Amazon purged political writer James Perloff’s latest book, “Covid-19 and the Agendas to Come: Red-Pilled,” from its platform for “violating content guidelines.”
With America descending deeper into an Orwellian state – Twitter has yet again banned another tweet, this time on Saturday, from Stanford professor and now White House advisor Scott Atlas.
Atlas tweeted Saturday morning that masks do not work to prevent the spread of the virus:
“Masks work? NO: LA, Miami, Hawaii, Alabama, France, Philippines, UK, Spain, Israel. WHO: “widespread use not supported” + many harms; Heneghan/Oxf CEBM: “despite decades, considerable uncertainty revalue”; CDC rvw May: “no sig red’n in inflnz transm’n”; learn why.”
Hours later, in a follow-up tweet, Atlas wrote:
“That means the right policy is @realDonaldTrump guideline: use masks for their intended purpose — when close to others, especially hi risk. Otherwise, social distance. No widespread mandates.”
As per a CNN report, Atlas’ tweet violated Twitter’s policy that “prohibits sharing false or misleading content related to Covid-19 that could lead to harm.”
The Federalist points out, in an emailed response via Atlas, an array of scientific data to back up his claim:
In the deleted tweet, I cited the following evidence against general population masks:
1) Cases exploded even with mandates: Los Angeles County, Miami-Dade County, Hawaii, Alabama, the Philippines, Japan, the United Kingdom, Spain, France, Israel.
2) Dr. Carl Heneghan, University of Oxford, director of the Centre for Evidence-Based Medicine and editor in chief of British Medical Journal Evidence-Based Medicine: ‘It would appear that despite two decades of pandemic preparedness, there is considerable uncertainty as to the value of wearing masks.’
3) The WHO: ‘The widespread use of masks by healthy people in the community setting is not yet supported by high quality or direct scientific evidence and there are potential benefits and harms to consider’ (http://bitly.ws/afUm)
I also cited an article giving a detailed explanation of the reasons why masks might not prevent spread: https://t.co/1hRFHsxe59
The tweet and surrounding removal from Twitter come as US COVID-19 cases in the US surged above 70,000 on Friday, the highest daily reading since July 24. Atlas’ tweet was also linked to an article in the American Institute for Economic Research that argues masks are not effective against the virus.
In the interest of “transparency”, Pfizer CEO Dr. Albert Bourlas released a statement on Friday outlining the timeline for when its experimental COVID-19 vaccine might be ready for approval for regular, non-emergency use. Much to Trump’s chagrin, CEO Dr. Albert Bourla said the earlier the company expects to apply for an emergency-use approval from the FDA would be the third week of November, after the election has come and gone.
While JNJ executives insisted their vaccine candidate likely wasn’t the cause, they brought in investigators and are now working to get the trial going again as quickly as possible. If what happened with the AstraZeneca-Oxford vaccine is any guide, it could be weeks before US regulators sign off on allowing the trial to resume. AstraZeneca-Oxford trial in the US has been paused for more than a month.
Back in September, AstraZeneca briefly halted global studies after UK regulators investigated a pair of patients who came down with symptoms of a rare illness which scientists worried might be connected with the vaccine. Trials in the UK and elsewhere restarted days later, but in the US, regulators have refused to allow the trials to resume.
Already, the time lost by JNJ and AstraZeneca-Oxford has pushed them out of the lead in the race to apply for an emergency use authorization from the FDA. Vaccine candidates being developed by Moderna and Pfizer-BioNTech have taken the lead.
But as Bloomberg pointed out in a piece published Saturday morning, both the AZ and JNJ vaccines relied on the same technique: the so-called adenovirus vector which was also used by the Gameleya Institute’s vaccine (aka Sputnik 5) and at least one of the leading Chinese vaccines.
And this year, with Covid-19 vaccines entering strongly into the politics of the hour, transparency and trust are key to fighting a virus that’s hit more than 39 million people globally and hamstrung economies. If concerns about side effects in experimental vaccines in trials using adenoviruses are validated, it could boost skepticism in the general public and raise questions for other drugmakers.
It would also amount to a considerable setback to adenovirus vector vaccines.
As Bloomberg explains, the adenovirus vaccine vector is nothing new to medicine. They are well studied and versatile, according to Bloomberg. Humans have been shown to easily tolerate them, which is what initially attracted scientists to experiment with this method for COVID-19. A J&J vaccine based partially on the method was recently approved to guard against Ebola.
However, the technique already has a couple of conspicuous blemishes on its safety record. Here’s one example: An AIDS vaccine based on the technique was abandoned after the virus was potentially tied to increased infections among those who received it.
In other experiments, though, there were disappointing results. In 2008, a vaccine using an adenovirus developed by Merck & Co. to prevent HIV was tied to increased infections among some who received it in a trial. Merck abandoned the shot, and several similar programs fell by the wayside.
Barely a week after applying for emergency use approval from the FDA for one of its COVID-19 antibody therapeutics, it appears trials for one of Eli Lilly’s therapeutic drugs focused on the virus (Eli Lilly is working on more than just one) have been paused.
News of the trial was broken by a doctor on Twitter before it was swiftly confirmed by several media organizations.
<BREAKING NEWS>https://t.co/UBH7CzwLj7 has learned that the ACTIV-3 trial testing Eli Lilly’s monoclonal antibody LY-CoV555 has been PAUSED.
Trial tests the antibody + remdesivir vs remdesivir alone.
Per the NYT report, the government-sponsored clinical trial has been paused because of a “potential safety concern.” The report cited emails that government officials sent on Tuesday to researchers at testing sites, which the company confirmed. The trial was designed to test the benefits of the therapy on hundreds of people already infected with the virus. The company did not say how many volunteers were sick, or any details about their illness.
Eli said in a statement that the independent monitoring board recommended the pause (unlike the JNJ pause announced last night, which was undertaken voluntarily, according to JNJ).
The pause in enrollment comes after Johnson & Johnson confirmed that it had voluntarily paused its Phase 3 vaccine trials after a participant in the 60k person trial came down with an unusual and unspecified illness. An AstraZeneca trial in the US has still not restarted more than a month after issues with a couple of patients caused them to briefly pause all trials around hte world, though all the others have restarted.