U.S. Approves Johnson & Johnson’s Coronavirus Vaccine, First Single-Dose Vaccine



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The Johnson & Johnson vacuna.  Johnson & Johnson / Document via REUTERS
The Johnson & Johnson vacuna. Johnson & Johnson / Document via REUTERS

The United States Food and Drug Administration (FDA) gave emergency approval for Johnson & Johnson’s vaccine on Saturday after a panel of experts recommended going ahead on Friday.

With the decision of this Saturday, J&J vaccine joins Pfizer and Moderna in the United States National Immunization Campaign.

“We will use all means imaginable to develop the manufacture of the vaccine”said President Joe Biden, whose country has more than 510,000 dead.

J&J had shown that your vaccine works as a single injection and can be stored at standard refrigerator temperature, which “offers logistical and practical advantages”.

While the United States remains the country with more deaths in absolute terms, showed significant progress in its vaccination campaign, with more than 50 million people vaccinated in five weeks.

Trials with the J&J vaccine have shown an efficacy against the coronavirus of 66%, compared to 94-95% of existing vaccines, but with an 86% ability to prevent severe cases of illness, hospitalizations and death, resulting in might be enough to protect the population.

The FDA cartel in the United States.  REUTERS / Andrew Kelly / file photo
The FDA cartel in the United States. REUTERS / Andrew Kelly / file photo

The vaccine J&J has been shown to be effective in all demographic groups in the United States, although the response during clinical trials varied among countries, with the United States recording a 72% effective, Latin America 66% and South Africa, where a more resistant and contagious variant of the virus has spread, 64%.

Experts believe it is proven that the vaccine is safe and does not cause serious reactions in those who receive it, while many members of the committee meeting this Friday recalled that the urgency of the fight against the pandemic justifies the emergency approval.

Some of the committee members, who unanimously recommended approval, recalled that J&J has resolved many doubts that existed six months ago and has put in place a strong surveillance plan and continued evolution of their vaccine, which like its predecessors was created in record time never seen before in history.

However, J&J has already suffered his first setback and this week confessed at a congressional hearing that It will be able to deliver around 20 million doses before the end of March and not 25 million as it had initially planned.

US President Joe Biden.  EFE / Doug Mills
US President Joe Biden. EFE / Doug Mills

The inclusion of the first single-dose vaccine is expected to help speed up the vaccination campaign by not requiring a second dose at three weeks, as is the case with injections from Pfizer and Moderna, although Johnson & Johnson said today they are considering possible annual boosters.

Most of the questions from FDA experts on Friday were about learn more about the pharmacist’s plans to treat possible variants of the coronavirus that are more resistant to vaccines, as is the case with the South African variant. In addition, specific boosters may be necessary for the more virulent variants and with the most vaccine resistant receptor structure.

The J&J vaccine does not require the extremely low storage temperatures as in the case of Pfizer and Moderna, as it is not based on messenger RNA, like its predecessors, but in instructions encoded in a DNA strand transmitted to the cell in an adenovirus, a technique less prone to spoilage.

For this reason, it can be kept up to three months between temperatures of 2 to 8 degrees Celsius, something that would reduce the complexity of the supply chain and scenes such as those experienced in parts of the country, where emergency vaccines were distributed to the population after issues with freezers.

EFE / John G. Mabanglo
EFE / John G. Mabanglo

The United States has administered since the end of December, when the first of the vaccines was authorized, more than 68 million doses, with just over 1 in 5 Americans already vaccinated with the first of two doses required.

With information from AFP and EFE

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