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Bradley Cortright September 16, 2020 0 Comments

Questions are swirling about the safety and efficacy of a COVID-19 vaccine if it is produced while President Donald Trump is in office, with many suggesting that the development process is being rushed for political purposes.

Democratic presidential nominee Joe Biden says that it is crucial that Americans raise questions about the vaccine development process and that a panel of scientists verify that the vaccine is safe and effective.

Speaking to reporters on Wednesday, Biden was asked if his attacks on Trump’s push to develop and approve a vaccine would hurt Americans’ trust in science.

“No, because they know he doesn’t have any respect for scientists,” Biden responded. “He basically said it. You saw what he said in California about wildfires, and scientists don’t know … and it’s going to go away like a miracle.”

He continued, “It’s necessary so people can trust the vaccine. And that’s why I said that you have to have this board of scientists that are going to say ‘this is why we think this is a good vaccine, why it’s approved.’ And it has to be total transparency.”

Biden reiterated his belief that having an outside board of scientists review the vaccine and investigate the development process is a critical step.

When asked if he was telling Americans not to trust Trump, but to trust him if he’s elected, Biden said, “No, I’m not. I’m saying trust the scientists.”

“It’s one thing for Donald Trump to say the vaccine is safe,” Biden continued. “Then give it the board of scientists. Have total transparency, so independent operators and scientists and companies go out and take a look at it. And what did you base that decision on? What did you do? Did you pressure the head of the FDA?”

“I’m not saying he would or will, but that’s what has to happen,” he added.

Watch the video below:

Asked if casting doubt on Pres. Trumps on vaccines could lead to some people doubting any potential vaccine if its released, Joe Biden tells @marykbruce, "No, because they know he doesnt have any respect for scientists. He basically said it."

— ABC News Politics (@ABCPolitics) September 16, 2020

When asked if he would take a vaccine if the board of scientists gave it a green-light, Biden said, “Absolutely. Do it. Yes. If those three questions I laid out can be answered, yes, absolutely.”

Trump previously called Biden “stupid” for questioning the safety of a vaccine and said the former vice president should apologize.

And on Wednesday at the White House, Trump accused Biden of “promoting his anti-vaccine theories.”

TRUMP: "Im calling on Biden to stop promoting his anti-vaccine theories because all theyre doing is hurting the importance of what were doing."

— Daily Caller (@DailyCaller) September 16, 2020

He said, “I’m calling on Biden to stop promoting his anti-vaccine theories because all they’re doing is hurting the importance of what we’re doing.”

Trump also charged that Biden was “recklessly endangering lives” by raising questions about the safe a vaccine approved under his tenure.

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Tags: donald trump joe biden coronavirus outbreak donald trump joe biden

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The first clinical trial with humans of a vaccine against Covid in Spain begins this Monday

Rocío Fernández OrtizSantander Updated: 09/13/2020 9:30 PM Save

The countdown begins for the Covid-19 vaccine that is being tested in Spain. This Monday the first doses of ‘Ad26Cov2S’ are started, than from the company Janssen de Johnson & Johnson, to the 40 volunteers from the Marqués de Valdecilla University Hospital in Santander. The Madrid centers of La Paz and La Princesa also participate in the study, but the injection to the 150 candidates who will be tested in the capital is delayed until Tuesday.

Thus, Cantabria becomes the starting point for an analysis that will last at least six months, when the first results of the clinical trial are expected to be known.

To administer the doses, Valdecilla – the flagship of Cantabrian and Spanish health and a national reference center – has selected the 40 volunteers from among the more than 250 registered applicants. The number of people needed to test the vaccine was completed just 24 hours after it was announced that the Santander hospital had been chosen for the study, on August 28, and the registration period was closed two days later when the threshold was exceeded. and, also, expectations.

The recruitment of volunteers began on September 1, with the physical visits of each of the candidates in which they were explained the characteristics of the trial, the commitments they must take and the risks it entails. After this, those who decided to participate in the project were subjected to an interrogation first and a physical examination and analytical studies later, to verify that they met the requirements, such as being healthy or having not been infected by SARS-CoV-2. Last Thursday they did blood samples and the relevant PCR test to rule out any alteration or contagion of coronavirus.

Among the volunteers chosen are the Cantabrian Manuela and Elisa, mother and daughter, who in an interview with this newspaper admitted that despite not knowing how their body was going to react to the injection, they had decided to take the step because “Someone has to end this”.

With the candidates selected and divided into two groups – from 18 to 55 years old and over 65 – all vaccinations will be done in a short period of time, approximately one week. And from the first dose will be followed up. There will be ten different groups for injections because different dosage profiles, different doses, will be tested in different time schedules. And there’s even a placebo one.

In consecuense, follow-up will be highly variable Depending on the groupings and the lists, they will be spaced between a month or a month and a half. The first results, which will be those that indicate whether the patients react from the point of view of the immune response to the vaccine, something that is verified analytically, will probably be within six months. But the follow-up of the volunteers has to be longer, to verify the safety of the vaccine.

And it is that the one of the Janssen laboratories is a phase 2a trial in which it is studied how calibrate the dose quantity to generate immunity, the differences between administering one or two doses, as well as the time interval that should pass between doses. The company also plans to start phase 3 clinical studies shortly.

This vaccine, the first trial against Covid to be developed in humans in our country, this vaccine is based on solidly documented technology and on a non-replicative recombinant adenovirus to generate an immune response against one of the coronavirus proteins known as protein S (from ‘spike’, also called spike protein in Spanish).

These clinical trials are part of the requirements that all investigational vaccine candidates must carry out to demonstrate their quality, safety and efficacy. Only after having evaluated, among other things, all the preclinical and clinical research carried out, the competent regulatory authorities authorize its commercialization: in the case of Spain, the European Medicines Agency (EMA) and the Spanish Agency of Medicines and Health Products (AEMPS).

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