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.'”
In September, Brazil’s wealthiest and most populous state Sao Paulo went into contract with Chinese vaccine developer Sinovac Biotech, with the expectations to receive 46 million doses of CoronaVac. CoronaVac has been in Phase 3 testing in the South American country since July. On Friday, Sao Paulo Governor Joao Doria said if the COVID-19 vaccine is approved by the National Health Regulatory Agency (ANVISA), then mandatory vaccinations would follow, according to the Rio Times.
Doria told reporters Friday, Oct. 16, that: “In Sao Paulo, it will be mandatory, except for those with a medical note and a certificate stating that they cannot [take the vaccine].”
Just weeks ago, he told other reporters that Sao Paulo “will be one of the first places in the world to vaccinate the public.” He said his administration has already obtained 6 million CoronaVac doses for potential distribution.
Citing local media, RT News said Sao Paulo could have the CoronaVac vaccine approved as early as December. The trials are expected to be wrapped up this weekend, with results expected sometime early next week.
Doria has spent the last couple of months blasting President Jair Bolsonaro’s handling of the public health crisis – accusing him of “politicizing” the vaccine.
Bolsonaro recently responded to Doria’s comments, saying that the Health Ministry will not make vaccination mandatory. Bolsonaro also cited federal laws that determine it’s up to the federal government to decide if vaccinations are mandatory.
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.
For centuries humanity has been plagued by influenza. In the United States, according to the CDC an average of 60,000 people are estimated to die each year from influenza. Further its estimated that more than 50 million people experience symptoms and contribute to as many as 740,000 hospitalizations.
The first flu vaccines for civilian use in the US came online in the late 1940’s. Decade after decade since, flu vaccines have been available every year with varying degrees of effectiveness with some years being as little as 10% effective.
Using today’s metric of explosion of cases, and tens of thousands dead — every single year we experience a flu epidemic globally. This despite the fact that we have plenty of vaccines, and they’re given for free upon demand in most countries yet not once in modern history have our efforts been able to make a discernible dent in the yearly epidemic.
For the first time in human history we’re on track to eradicate the flu and apparently the vaccine had nothing to do with it.
While 2020 started the year with above average cases things quickly changed as COVID-19 approached. During week 11 (week ending March 14th) there were 11,767 clinically confirmed cases of influenza according to the CDC. But by early April, during week 14 the cases had collapsed by 97.3% to just 318. Contrasted against week 14 in 2019 which had 5471 cases, and 2018 which had 3314 cases shows an unprecedented collapse in influenza.
The power of the flu has never returned since, with every week being far below the previous years numbers.
Zooming in to weeks 20-39 the disparity becomes apparent. On average, weekly cases are 96% lower than in 2019. Even when we compare the numbers to 2018 which had lower cases than 2019, 2020 is still on average 86% lower than 2018.
Which begs the obvious question, have we finally conquered the flu? Or have we just rebranded it?