The FDA team unanimously recommends Johnson & Johnson’s Covid booster injections to adults who have already received the first dose

Read Time:4 Minute, 48 Second

On the first day when the Johnson & Johnson vaccine was resumed at the site, a nurse administers the injection at the COVID-19 vaccination site supported by FEMA at Valencia State University.

Paul Hennessy | Light Rocket | Getty Images

On Friday, an influential Food and Drug Administration Advisory Committee stated that the agency should authorize Johnson & Johnson’s single Covid-19 vaccine booster to more than 15 million Americans who have received the initial dose.

The unanimous vote of the agency’s vaccine and related biological products advisory committee is a key step before the United States begins to provide second shots to Johnson & Johnson recipients, some of whom said they are eager to obtain additional protection. Studies have shown that one dose of Johnson & Johnson’s vaccine is less effective than two doses of messenger RNA vaccines produced by Pfizer BioNTech and Moderna. The team recommends this dose to all people 18 years and older. They have received the first dose of Johnson & Johnson’s vaccine. Many committee members said it should be treated as a two-dose vaccine, just like Moderna and Pfizer’s. Same as the vaccine.

On Thursday, the same committee recommended Moderna booster injections to people 65 years and older and other high-risk adults based on Pfizer vaccine guidelines.

The FDA usually follows the committee’s recommendations, and its regulatory agency may make a final decision within a few days. However, the agency is not the final approval. Next week, the Vaccine Advisory Group of the Centers for Disease Control and Prevention will decide who should receive additional Johnson & Johnson vaccines. If it issues a recommendation and the CDC Director Dr. Rochelle Walensky signs and agrees, the booster injection can begin immediately.

Johnson & Johnson obtained the vaccine authorization in late February and asked the agency to approve a booster shot of its vaccine on October 5 for people 18 years and older. The data it submitted showed that the performance of the second dose of vaccine and mRNA vaccine, two months after the first vaccination in the United States, increased the protection rate of symptomatic infection from 72% to 94%.

A few days before the Friday meeting, FDA scientists published an analysis of Johnson & Johnson’s application for boosters, questioning the strength of the data. The FDA stated that people might benefit from the second dose, but added that the information provided by the company is limited and the agency has not verified all of it. It acknowledged that in clinical trials and real-world research, the effect of a single-dose Johnson & Johnson vaccine has always been inferior to that of the mRNA vaccine.

Before the vote, some committee members asked whether the FDA could postpone the decision on the booster, saying that it may be too early because there are still many unanswered questions. Other members wanted to know why the agency submitted Johnson & Johnson’s application to the committee before it was able to verify all the data.

Dr. Cody Meissner of Tufts University said: “Can it be said that it is a bit early? There are still many issues that have not been resolved.” “There are a lot of uncertainties, so it is difficult to vote for or against tonight.”

In explaining the speed of the review, Dr. Arnold Monto, the chairman of the committee, pointed out that Johnson & Johnson’s disposable vaccines performed poorly compared to Pfizer and Moderna.

He said: “There is a public health priority here, because what we see is that this is a group whose overall efficacy is lower than what we see in mRNA vaccines, so some measures are urgently needed.”

FDA officials admitted in a speech in front of the expert panel that Johnson & Johnson’s trial was completed with a small sample of participants, so it is difficult to draw conclusions on the data. Dr. Peter Marks, the agency’s top vaccine regulatory agency, asked the group to advance the meeting and resolve any outstanding issues of the members at the end.

Dr. Johan Van Hoof, director of vaccine development at Johnson & Johnson, told the committee that a booster immunization 6 months after the initial vaccination resulted in a 12-fold increase in antibodies.

Van Hoof said that the booster dose six months later also increased the vaccine’s effectiveness against Covid variants (including the highly transmitted delta strain) proportionally. The company’s data is based on 17 volunteers between the ages of 18 and 55. A larger study of 51 trial participants found that after the Johnson & Johnson booster was given two months after the first dose, antibodies increased by nearly five times.

FDA medical officer Dr. Timothy Brennan told the agency’s advisory committee that the 17 participants in the Johnson & Johnson 6-month trial had no new adverse side effects. After receiving the Johnson & Johnson booster, approximately 47% of participants reported headache symptoms, 26% reported fatigue, and 21% reported myalgia or muscle pain.

Johnson & Johnson executive officer Dr. Macaya Douoguih said that there is no data showing that people are at increased risk of rare but severe blood clots after receiving a second dose of Johnson & Johnson vaccine.

She provided data on the second dose of AstraZeneca vaccine in the UK, which uses a platform similar to Johnson & Johnson. Data show that the incidence of immune thrombotic thrombocytopenia (VITT) caused by the vaccine after the second vaccination is lower than the first.

“Although the vectors are not exactly the same, the data may provide some insights into potential risks,” Douoguih said.

This is a story of development. Please check for updates.

If you want to know more about business please go to

0 %
0 %
0 %
0 %
0 %
0 %
We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We also share information about your use of our site with our social media, advertising and analytics partners. View more
Cookies settings
Privacy & Cookie policy
Privacy & Cookies policy
Cookie name Active

Who we are

Suggested text: Our website address is:


Suggested text: When visitors leave comments on the site we collect the data shown in the comments form, and also the visitor’s IP address and browser user agent string to help spam detection. An anonymized string created from your email address (also called a hash) may be provided to the Gravatar service to see if you are using it. The Gravatar service privacy policy is available here: After approval of your comment, your profile picture is visible to the public in the context of your comment.


Suggested text: If you upload images to the website, you should avoid uploading images with embedded location data (EXIF GPS) included. Visitors to the website can download and extract any location data from images on the website.


Suggested text: If you leave a comment on our site you may opt-in to saving your name, email address and website in cookies. These are for your convenience so that you do not have to fill in your details again when you leave another comment. These cookies will last for one year. If you visit our login page, we will set a temporary cookie to determine if your browser accepts cookies. This cookie contains no personal data and is discarded when you close your browser. When you log in, we will also set up several cookies to save your login information and your screen display choices. Login cookies last for two days, and screen options cookies last for a year. If you select "Remember Me", your login will persist for two weeks. If you log out of your account, the login cookies will be removed. If you edit or publish an article, an additional cookie will be saved in your browser. This cookie includes no personal data and simply indicates the post ID of the article you just edited. It expires after 1 day.

Embedded content from other websites

Suggested text: Articles on this site may include embedded content (e.g. videos, images, articles, etc.). Embedded content from other websites behaves in the exact same way as if the visitor has visited the other website. These websites may collect data about you, use cookies, embed additional third-party tracking, and monitor your interaction with that embedded content, including tracking your interaction with the embedded content if you have an account and are logged in to that website.

Who we share your data with

Suggested text: If you request a password reset, your IP address will be included in the reset email.

How long we retain your data

Suggested text: If you leave a comment, the comment and its metadata are retained indefinitely. This is so we can recognize and approve any follow-up comments automatically instead of holding them in a moderation queue. For users that register on our website (if any), we also store the personal information they provide in their user profile. All users can see, edit, or delete their personal information at any time (except they cannot change their username). Website administrators can also see and edit that information.

What rights you have over your data

Suggested text: If you have an account on this site, or have left comments, you can request to receive an exported file of the personal data we hold about you, including any data you have provided to us. You can also request that we erase any personal data we hold about you. This does not include any data we are obliged to keep for administrative, legal, or security purposes.

Where we send your data

Suggested text: Visitor comments may be checked through an automated spam detection service.
Save settings
Cookies settings