Johnson & Johnson Request Emergency Approval from FDA – Global Markets

Johnson & Johnson has submitted an application to the FDA for an emergency approval for the corona vaccine it has developed, which is given in a single dose. The US FDA Vaccine Committee is expected to convene only at the end of the month, but based on past experience, the requests that reached the committee’s table were approved within a day of its convening, so the wait is not expected to be long. If the application is approved, it will be the third vaccine distributed in the country.

The company’s chief scientist, Dr. Paul Stoppels, said Johnson & Johnson was ready to deliver the vaccines as soon as the request was approved. “Along with the application we submitted to the FDA and our tests with other regulators around the world, we are working with great urgency to get our vaccine distributed to the public as quickly as possible,” Stoppels said in a statement.

Unlike the Modern and Pfizer vaccines, the storage requirements of the one developed by Johnson & Johnson are less rigid, and as mentioned, one dose of it is enough compared to two in the competitors. However, the company reported an efficiency of 66%, lower than an efficiency of about 95% at Modern and Pfizer. It should be noted that Johnson & Johnson has been informed that the vaccine has been found to be ineffective against the South African variant.

Some drug companies believe that an additional dose, a third in the case of Moderna and Pfizer, may lead to the development of additional antibodies that can for the various mutations, while others believe that an update of the vaccine itself is needed.

The FDA’s acting chairman, Dr. Janet Woodcock, said the director of drugs is working to formulate a policy to approve such adjustments, whether in vaccines that have already been approved or in drugs for respiratory illness that develop following virus infections. Woodcock added that the FDA Will examine where they can find regulatory flexibility.

“We are aware that some of the developments that have already been approved or are still under development are less effective against the mutations that have been created, and we are working with drug developers to accelerate the development of new therapies that will be effective against them,” Woodcock revealed.

As for the same corona-infected drugs that developed the disease, Gilead, for example, reported that 50 percent of those hospitalized in the United States were treated with their drug Remediesibir – the only one approved so far. Against the background of the spread of the virus, sales of the drug, which cost more than $ 2,000, grew, of course, and amounted to about $ 1.9 billion in the fourth quarter of 2020 alone. In the third quarter, it was $ 0.8 billion.

Gilead expects by the end of 2021 Ramadan Siberian sales to stand at $ 2-3 billion. The chief scientist at the company noted in a conversation with investors that the effectiveness of the treatment does not seem to be affected by the various variants that are spreading in the United States.

The company is working on a version of Ramsibir for inhalation and this requires separate clinical trials that have not yet been completed. These are now only in the first phase, and Gilead representatives did not provide an expectation of the date of completion of the trials.

At the same time, there is an acceleration in investments in home corona tests. One of them, the combined one of Wizby Medical, which locates influenza and corona, received federal funding from the US government of $ 12 million to accelerate production. The rapid PCR test can provide results within half an hour. Another test by Australian company Alum has already received FDA approval, but its distribution is delayed.