Janssen Vaccine Applying for FDA Approval… 66% efficacy, lower than Pfizer

The US pharmaceutical company Johnson & Johnson announced on the 4th (local time) that it has applied to the Food and Drug Administration (FDA) for emergency use of the corona 19 vaccine developed by its subsidiary Janssen.

Accordingly, CNN and others reported that the FDA advisory body Vaccine and Biological Drugs Advisory Committee (VRBPAC) will discuss whether to approve the emergency use of the Janssen Corona 19 vaccine at a meeting on the 26th. “With FDA approval, we will start supplying it to the US government as soon as possible,” said Paul Stoffels, Johnson & Johnson Chief Science Officer.

Johnson & Johnson has applied for emergency use of the subsidiary Janssen’s Corona 19 vaccine to the US FDA. [AFP=연합뉴스]

If the Janssen vaccine is approved for use by the FDA, it will be the third vaccine available in the United States after Pfizer Modena vaccine. It is also expected to be the first’one-time inoculation’ Corona 19 vaccine to be approved by the FDA. This is because unlike other corona19 vaccines, which have to be given twice, it only needs to be given once. “The application for emergency use of the single-inoculated corona 19 vaccine is an important step toward ending Corona 19,” said Stoffels.

The United States plans to bring in a total of 100 million Janssen vaccines in the first half of this year. Korea has signed a contract for 6 million and is planning to introduce it in the second quarter of this year. Janssen vaccine is a viral vector vaccine that injects a harmless virus into the human body like the AstraZeneca vaccine. It has the advantage of being easy to distribute because it can be stored at room temperature.

However, on the 29th of last month, Johnson & Johnson announced that the Janssen vaccine recorded an average of 66% preventive effect in a phase 3 clinical trial conducted in various countries. It is less effective than Pfizer Moder or vaccines, which showed an effect of around 95% in phase 3.

Pfizer vaccination is taking place in the UK. [AFP=연합뉴스]

In the UK, a study found that the immunity effect was 90% 21 days after one shot of the Pfizer vaccine. According to Guardian et al., researchers at the University of East Anglia in the UK analyzed 500,000 cases of Pfizer vaccines in Israel and obtained the results. The researchers revealed that there was virtually no change until the 14th day after the first vaccination, but after that, the effect gradually appeared and the immune effect rose to 90% on the 21st day.

In response, the researchers evaluated, “It may take up to 21 days to obtain an immune effect of 90% after one dose of the Pfizer vaccine, but even one dose of the vaccine has a very high protective function.” He added, “It is not known whether the immunity resulting from a single vaccination will last for more than 21 days,” he said. “There will be no significant decrease after 9 weeks after vaccination.”

This is an efficacy that exceeds the results of a phase 3 clinical trial of Pfizer vaccine. Initially, Pfizer said that an average of 52% of the infection prevention effect was obtained when the vaccine was given in Phase III. However, as a result of the second vaccination three weeks after the first vaccination, the preventive effect increased to 95%.

They are vaccinated against Corona 19 on the 4th in Israel. Israel has expanded the age of vaccination to be over 16. [AFP=연합뉴스]

Meanwhile, the cumulative number of corona 19 vaccine vaccinations around the world as of the 4th exceeded the cumulative number of corona 19 confirmed cases. According to the international statistics site Our World In Data, the number of vaccinated COVID-19 vaccines in the world was estimated at 173.34 million (including the second dose). This surpassed approximately 15.42 million cumulative confirmed cases worldwide. To date, 83.83 million people in the world have been vaccinated once or twice.

Of the 70 countries that are vaccinated, Israel (38.11%) has the highest vaccination rate relative to the population. According to the Israeli Ministry of Health, about 3.36 million people received the primary vaccination as of the 5th day, of which 1.96 million people completed the 2nd vaccination. Since the 4th, Israel has expanded the age of the Corona 19 vaccination to 16 years or older.

Reporter Lim Sun-young [email protected]