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The FDA Shows Green Light To Johnson & Johnson As It Becomes The Third Vaccine To Get Emergency Use Approval

At a time like this, there is a new vaccine that has found approval in the United States, which is going to aid it in its fight against COVID-19. The food and drug administration of the country has now said that Johnson & Johnson’s one-shot coronavirus vaccine appears to be safe and effective in the trials. The new documents published by the FDA paved the way for Johnson & Johnson’s approval for emergency use. The FDA panel of independent experts will meet this Friday, to decide whether to approve the shot. While it is not bound to follow the advice of its experts the FDA did so when authorizing Pfizer and modern vaccines. The company said last month that Johnson & Johnson’s vaccine was 66% effective in preventing covert 19 against multiple variants. In a global trial that involved nearly 44 000 people, its effectiveness varied from 72 percent in the united states to 66 in Latin America and 57 in South Africa where a new variant has now spread. Though the vaccine was 85 percent effective overall in stopping severe cases of the disease. The vaccine was effective in reducing the risk of COVID-19, and preventing PCR tests confirmed COVID-19 at least 14 days after vaccination. 

Three vaccine recipients had severe side effects in the trial but the FDA says that its analysis did not raise any specific safety concerns that would preclude the issuance of an emergency use authorization. Johnson & Johnson had not previously released details of its clinical trial data beyond the efficacy rates. Experts in India believe that this single-dose vaccine will be excellent in controlling outbreaks. With the current infrastructure, India can manufacture about 600 million doses a year. This can help drastically reduce hospital admissions and COVID-19 fatalities. Our correspondent nick harper with us from Washington DC for more on these developments

This is great news for America’s COVID-19 vaccination drive. What more is the likelihood of this jab getting approval which if it happens will be a huge shot in the arm for the country’s fight against the disease. Great news for America and great news for Johnson & Johnson. This independent study that was put together by the food and drug administration here in the US shows that the drug is very effective and it’s particularly effective when it comes to severe cases. So, that means that it reduces the risk of hospitalization and death. Now overall it showed that here in the US it was 72 percent effective but in severe cases, in the US, it was 86 percent effective. The food and drug administration has done this analysis, all this will be studied on Friday by their advisory panel and before the end of the day on Friday they will put forward a recommendation on whether the FDA should approve the vaccine. 

After this analysis, the likelihood is that they will give that recommendation and that then clears the way for a vote on Saturday for the FDA to be able to approve that and that would be good news because the US already has two different types of vaccines approved here in the US -the Pfizer and Moderna ones. This would be the third and it also comes with significant benefits. It is something that doesn’t have to be stored at quite the sub-zero temperature that the Moderna and Pfizer vaccines do, it also has a longer shelf life of about three months as opposed to just a few days, and it is a single-shot vaccine unlike the Moderna and Pfizer ones where two doses are needed a month apart. This is certainly a significant development for the country but also for the US in its efforts to try and get the whole population vaccinated.

The United States has lost 500,000 people while the vaccination drive Continues the cases also continue to rise, so what are the experts saying at this point about the spread of the disease? It is continuing to spread but if you look at the two-week average, we are seeing the number of deaths, the number of hospitalizations, and the number of new infections fall in particular death down by about 40 percent. The real issue at the moment is getting everyone vaccinated. So far just over six percent of the US population have had both doses of either Moderna and Pfizer.

Trying to get almost 330 million people vaccinated is proving very difficult and we have seen that the logistical ability of the US to roll out the vaccines to all of those pharmacies and supermarkets right across the country has been particularly challenging. There is also a worry that even though this is good news the efficacy rates of the Johnson & Johnson vaccine, the company is already saying that it’s unlikely to be able to deliver all of the doses that it had originally promised. It’s now saying that it will have somewhere between two and four million doses available for the US after approval is potentially given on Saturday. That’s well below the 12 million that it had originally promised by the end of this month. So, it’s trying to ramp up production, the US in turn is trying to ramp up the rollout but it’s certainly not going as quickly as the government and many health officials across the US would like.

 

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