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  HOME | USA

US Begins Test of COVID-19 Vaccine with 60,000 Volunteers

WASHINGTON – Janssen Pharmaceutica, owned by US multinational Johnson & Johnson, launched on Wednesday one of the world’s largest tests of a vaccine against COVID-19 with 60,000 volunteers, a move that immediately became the subject of political debate.

“Big news,” said Trump on Twitter shortly after the report became public.

The president went on to call for the quick approval of the potential remedy by the Food and Drug Administration, an independent government agency that is in charge of approving the use of new medications, vaccines and other products related to public health.

“Numerous great companies are seeing fantastic results. FDA must move quickly!” the president tweeted.

With the Janssen vaccine, there are already four separate drugs in the US that have entered phase three, the last of three phases during which the developing companies seek to prove their products’ efficacy and safety before definitive approval for widespread use. The other three pharmaceutical firms that have brought their vaccines to phase three so far are Moderna, AstraZeneca and Pfizer, the latter in cooperation with Germany’s BioNTech.

Janssen’s vaccine has two advantages over its competitors: it is not necessary to store it at below-freezing temperatures, a characteristic that would facilitate its distribution, and immunization can occur in patients after just one dose, in contrast to two doses for the other drugs currently being tested, according to a statement by the National Institute of Allergy and Infectious Diseases (NIAID).

According to NIAID, the 60,000 volunteers will be recruited at 215 hospitals around the country and in other countries, like Spain, where it has already undergone testing in three hospitals.

The latest clinical trial is part of Operation Warp Speed launched by the US government to accelerate the development of COVID-19 vaccines and treatments.

The urgency of developing a vaccine that Trump has expressed in recent weeks concerns members of the Democratic opposition, who fear that the president may be interfering in the process of reviewing a vaccine to benefit himself politically in the Nov. 3 election.

Last Wednesday, Trump promised to distribute 100 million doses of a vaccine before the end of the year, thus contradicting one of the government’s top health experts, Dr. Robert Redfield, who a few hours earlier had confirmed that the majority of the US population will not have access to a vaccine until the third quarter of 2021.

On Wednesday in a Senate hearing, Redfield, the director of the government-run Centers for Disease Control and Prevention, refused to respond to questions about that confrontation with the president, saying only: “My agency and myself are committed to data and science, and to giving the American public the best public health recommendations we can.”

Redfield also said that he was not going to start modulating what he says depending on whether someone agrees with him about it or not.

The CDC chief appeared before the Senate along with Stephen Hahn, who heads the FDA, and responded to questions about the safety of the vaccine.

In front of senators from both parties, he promised that the “FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families.”

Hahn said that his agency will follow rigorous procedures to prove that any vaccine is safe, adding categorically that the safety and efficacy of a vaccine will not be determined by any political actors but rather by career FDA scientists.

“I will fight for science. I will fight for the integrity of the agency,” Hahn said, pushing back against Democratic lawmakers’ concerns that the political considerations of Trump and/or other administration officials would influence the speed with which a vaccine is released.

His remarks come as the FDA is weighing publishing regulations that would make it more difficult for Trump to authorize the urgent use of a potential vaccine against the coronavirus, a situation that would allow an additional precautionary level to be added to the evaluation process.

Meanwhile, the virus continues to spread in the US, maintaining its trend in recent weeks, and the country remains the one hardest hit in terms of confirmed COVID-19 cases and deaths – some 6.9 million cases and 201,000 deaths – according to the independent tally being kept by the Johns Hopkins University.

In addition, according to JHU, at least 22 of the 50 states have reported in the last few hours an increase in new cases, and this is a significant increase with respect to last Monday, when just nine states reported spikes in the number of confirmed cases.

The majority of the US states that are reporting the new cases are in the Midwest, including Wisconsin, where Democratic Gov. Tony Evers this week declared a state of emergency and issued a new rule obligating local residents to wear facemasks.

 

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