Food and Drug Administration

Johnson & Johnson has announced Tuesday it will "proactively delay the rollout of our vaccine in Europe" after six women in the US developed a rare disorder involving blood clots.

"The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our Covid-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported US cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine," the company said. "In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe. We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public."

After six women developed a rare disorder involving blood clots after being administered the single-shot Johnson & Johnson vaccine, US health agencies have called for an immediate pause of the vaccine.

“Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution,” the Food and Drug Administration wrote on Twitter.

Due to a manufacturing error, a batch of Johnson & Johnson's (J&J) Covid 19 vaccine is unusable. There was a problem with a drug substance for its vaccine that did not meet quality standards at Emergent Biosolutions' manufacturing facility, the US pharmaceutical company said on Wednesday.

The error had been reported to the FDA and more staff were now assigned to monitor production.

The US Food and Drug Administration (FDA) granted emergency approval for the preparation on Saturday (local time). US President Joe Biden spoke of "inspiring news for all Americans and an encouraging development in our efforts to end the crisis". There is "light at the end of the tunnel", but no reason to sound the all-clear, he warned on Saturday evening (local time).

The US Food and Drug Administration (FDA) has approved cabotegravir and rilpivirine injection – called Cabenuva – as a long-acting treatment for HIV-1 infections in adults. The new treatment is the first injectable treatment that has to be administered on a monthly basis, replacing daily pill medications to control the infection of the AIDS virus.

The U.S. Food and Drug Administration (FDA) granted emergency approval Friday evening to the vaccine made by Mainz-based biotech company Biontech and its partner Pfizer.

The Washington Post reported that White House Chief of Staff Mark Meadows told Hahn on Friday to resign if the vaccine, made by Mainz-based Biontech and its U.S. partner Pfizer, is not approved before the end of the day (local time).

In order to allow wider use of marijuana for medical purposes, Thailand's Narcotics Control Board has voted to remove cannabis plants from the list of Category 5 narcotics.

However, growing marijuana is only allowed if a permit is granted by the FDA to ensure alignment with government agencies.

On Friday, Pfizer and BioNTech are submitting an emergency use authorization request for their Covid-19 vaccine to the US Food and Drug Administration. While it's unclear how long the process will take, the US government is expected to approve the vaccine until mid-December.

"The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose," Pfizer said in a statement posted on its website.

The US Food and Drug Administration (FDA) has approved Remdesivir, a broad-spectrum antiviral medication, as the first Covid-19 treatment. According to a study by U.S. National Institutes of Health, Remdesivir can cut the time of recovery from 15 to 10 days.

The US Food and Drug Administration has approved the use of convalescent plasma as Covid-19 treatment as the "known and potential benefits of the product outweigh the known and potential risks of the product." Even before the approval, around 70,000 people had been treated with convalescent plasma.

President Trump, after harshly criticising the speed of approval of treatments and vaccines, was pleased with the fast decision. "Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives. Today's action will dramatically increase access to this treatment," so the President.

A saliva-based Covid-19 test developed by the Yale University and funded by the National Basketball Association and the National Basketball Players Association has gotten emergency authorization by the United States Food and Drug Administration.

The new salvia test from Yale University only costs around $4, compared to $60 in the best cased for the competing salvia test that has been developed at Rutgers University lap. Both tests have been granted the same permission by the Food and Drug Administration.

The US government has agreed to pay $1.95 billion for 100 million Covid-19 vaccine doses to American pharmaceutical company Pfizer and German biotechnology company. The vaccine called BNT162 is currently still in development and early clinical trials. The agreement further states that the US could buy another 500 million doses, provided that the vaccine is both safe and effective as well as approved b the US Food and Drug Administration.

The Unites States Food and Drug Administration (F.D.A.) has announced that they will revoke the emergency authorization for the usage of two malaria drugs as treatment for Covid-19. In the statement the F.D.A. states that the drugs are "unlikely to produce an antiviral effect".

Johnson & Johnson, multinational medical and pharmaceutical corporation, said in a statement on Sunday that they "aim to deliver 1 billion (Covid-19) vaccines next year". According to Paul Stoffels, chief scientific officer, the company is starting clinical trials in September and is planning to upscale their manufacturing to be able to start producing the vaccine late this year. Stoffel added “We will have some vaccine available this year, but it will depend on the authorities – the FDA and others – to decide whether it can be used earlier, before efficacy data are available".