Zients says J&J vaccine pause should reassure vaccine sceptics – latest

FDA choosing to pause Johnson & Johnson vaccine should reassure public, White House claims

During a White House press briefing, Jeffrey Zients and Dr Anthony Fauci were asked how the recommended pause of the Johnson & Johnson vaccine would influence public confidence in receiving a jab amid the coronavirus pandemic.

Mr Zients claimed that the pause, which was recommended by the Food and Drug Administration and Centers for Disease Control and Prevention, should reassure the public that the federal health agencies were closely monitoring the vaccines.

He described the FDA as the “gold standard” in making science-based decisions.

Critics have said the pause might increase vaccine hesitancy among the public, but Mr Zients said instead argued it could make people more confident in receiving a vaccine because it showed how safety was being monitored amid the rollout.

Dr Fauci reiterated that perspective.

“I think it’s actually a very strong argument for safety,” Dr Fauci said. 

White House notified last night about FDA and CDC announcement

Jeffrey Zients, the White House Covid-19 response coordinator, was asked during a press briefing on Tuesday about when the Biden administration was informed about the Food and Drug Administration and Centers for Disease Control and Prevention announcement about the Johnson & Johnson vaccine.

He revealed that the federal agencies told the White House last night that there would be an announcement regarding the vaccine and the rare cases of blood clots developing in recipients.

“We were notified last night that there would be an announcement this morning,” Mr Zients said.

“We want the science agencies to lead with science. There is no reason for us to be involved in science decisions. This administration will be led by science,” he added.

Mr Zients went on to call the federal agencies the “gold standard” for science-based decisions and leadership in the United States.

Watch live as Dr Fauci joins White House press briefing

Dr Fauci says there are no ‘red flag signals’ from Moderna and Pfizer vaccines

Dr Anthony Fauci, the nation’s leading infectious disease expert, has insisted that officials were seeing “no red flag signals” from the Moderna and Pfizer Covid-19 vaccines amid news about the Johnson & Johnson vaccine.

He added that reports of adverse effects from Johnson & Johnson’s vaccine were very rare and insisted that vaccine rollout was not rushed.

“I think this is an unusual occurrence of a serious adverse event,” Dr Fauci said. “[The FDA and CDC] are pausing so they can look at it more carefully.”

He continued: “You want to make sure that safety is the important issue here. That is why you see the word pause … we want to leave that up to the FDA and CDC to investigate this quickly. I don’t think we pulled the trigger too quickly [to pause administering vaccines].”

Dr Fauci said that the White House would also not “override” the decision made by the CDC or FDA for “political reasons”.

“FDA is internationally known for the safest products out there. We want to get this resolved as quickly as possible,” he said.

On Wednesday, the CDC will hold an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) to review the individual blood clot cases. The FDA will also review the ACIP’s analysis as it investigates the cases.

White House adviser reiterates US vaccine supply will not be impacted

Jeffrey Zients, the White House Covid-19 response coordinator, has again reiterated that the temporary pause in the Johnson & Johnson vaccine would not impact the United States in its vaccination rollout efforts.

“The president has always said this is a wartime effort … and as such we have mobilised a wartime effort so we are prepared for a variety of scenarios,” Mr Zients said.

He said that the Johnson & Johnson vaccine made up only about 5 per cent of vaccine doses administered this week.

As of late, the federal government has been shipping about 25 million doses of Pfizer and Moderna to states each week. Mr Zients said that 28 million doses will be shipped this week.

“We have more than enough supply of Moderna and Pfizer vaccines,” he said.

President Joe Biden set a goal of the country administering 200 million vaccine doses within his first 100 days of office. Mr Zients said that the country was still anticipated to reach that goal despite the FDA’s recommended pause in administering the single-dose Johnson & Johnson vaccine.

CDC and FDA to launch investigation into Johnson & Johnson vaccine

The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have launched an investigation into the Johnson & Johnson vaccine after six people developed severe blood clots after receiving the jab.

On Wednesday, the CDC will hold an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) to review the individual blood clot cases. The FDA will also review the ACIP’s analysis as it investigates the cases.

This comes as the federal agencies’ released a joint statement on Tuesday that advised vaccination sites to pause administering the vaccine.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Peter Marks, director the FDA’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, the principal deputy director of the CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

Out of the more than 6.8 million single-dose Johnson & Johnson vaccines administered to date, six people have developed a severe disorder that causes blood clots.All cases occurred in women between the ages of 18 to 48, and symptoms occurred six to 13 days after receiving the vaccine, according to the joint statement.

The federal agencies would now review the cases to determine if safety advice should change when administering the vaccine.

“We expect it to be a matter of days for this pause,” said Dr Janet Woodcock, the acting FDA commissioner, on a phone call with reporters on Tuesday.

“We are recommending a pause in order to help the healthcare system recognise and treat patients appropriately,” Dr Schuchat added. “The safety of the vaccines and the safety of the American people is the utmost importance to us.”

FDA official says similarities between AstraZeneca and J&J vaccine ‘plainly obvious’

Experts have found what appears to be similarities between the rare blood clots developed in those who received AstraZeneca’s Covid-19 vaccine to those developed by people who received Johnson & Johnson’s vaccine, the Food and Drug Administration (FDA) revealed on Tuesday.

“It’s plainly obvious to us already that what we’re seeing with the Janssen vaccines looks very similar to what was being seen with the AstraZeneca vaccine,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a media briefing. Janssen is the vaccine arm of the pharmaceutical company.

Reports of people developing rare blood clots after receiving the AstraZeneca vaccine have circulated around Europe. Following an investigation, the European Medicines Agency concluded that unusual blood clots with low blood platelets should be listed as “very rare side effects” to receiving the jab.

“The AstraZeneca is a chimpanzee adenoviral vector vaccine. The Janssen is a human adenoviral vector vaccine,” Dr Marks said. “We can’t make some broad statement yet, but obviously they are from the same general class of viral vectors.”

AstraZeneca has not received emergency use authorisation in the United States to distribute its vaccine to the American public.

At this time, the FDA and CDC had no details on whether specific subgroups of the American population were at risk of developing blood clots after receiving the Johnson & Johnson vaccine. Dr Marks said the clots likely formed due an “immune response to that occurs very, very rarely after some people receive the vaccine.” 

“That immune response leads to activation of the platelets and these extremely rare blood clots,” he added. 

One person who experienced a rare blood clot after receiving the Johnson & Johnson vaccine has died, Dr Marks said, and another person was in critical condition. 

Trump blames Biden and complains about FDA hurting his election chances

Donald Trump has accused the Biden administration of doing “a terrible disservice to people throughout the world” by allowing a pause in the distribution of the Johnson & Johnson Covid-19 vaccine, writes Oliver O’Connell.

The former president said in a statement that the reputation of the vaccine will now be “permanently challenged” and people who have taken it will be “up in arms” after the decision by the Centers for Disease Control and Prevention and the Food and Drug Administration.

A pause in the distribution of the vaccine was called by the federal agencies while they investigate rare cases of blood clots in six people who received the single-dose shot.