What does FDA’s full approval of the Pfizer jab mean? – National & International News – TUE 24Aug2021

What does the FDA’s full approval of the Pfizer jab mean? Taliban says it is now stopping Afghans from going to Kabul airport.

NATIONAL NEWS

What does the FDA’s full approval of the Pfizer jab mean?

In a recent survey, 3 in 10 still-unvaccinated people said they were waiting for the FDA to give full approval to one of the vaccines. That day finally came yesterday when the FDA granted full approval to Pfizer’s COVID vaccine. It remains to be seen how much of a difference that news will make to people who are still on the fence, but there are some good reasons that it should persuade them.

The FDA granted emergency use authorization to for the Pfizer vaccine in December to combat the public health crisis. To obtain this emergency authorization, the FDA only required Pfizer, and all the vaccine producers, to submit two month’s worth of safety data. This is because adverse side effects from any vaccine are most likely to appear, if they appear, within that two-month window. Full approval for any vaccine requires 6 months worth of follow-up data.

The FDA has now completed the full review process for the Pfizer jab that it undertakes for all traditional vaccines. During this review, the FDA studied hundreds of thousands of pages of data, which is why full approval for vaccines normally takes years. In light of the urgency, the FDA accelerated this review process. They concluded that the evidence is now overwhelming that the vaccine and safe for use and very effective in preventing hospitalizations and death from COVID-19.

What does the FDA know now that it didn’t know in December?

Dr. Francis Collins, director of the National Institutes of Health, says that the review encompassed several factors. First is follow-up data on the 40,000 original participants in Pfizer’s early vaccine trials. Second is real-world data that shows that the vaccine has provided millions of people in the US and all over the world with effective protection against death or hospitalization from COVID. Third, FDA inspectors have visited manufacturing sites to review the production process step-by-step and ensured that the manufacturing conditions are safe.

What does this mean for mandates from public and private institutions?

Within hours of yesterday’s announcements, numerous universities and businesses announced further vaccine mandates for employees or students. Many institutions had already done so, and have successfully defeated any legal challenges they faced. But others, including the US military and some state and local governments, were waiting for full approval to make sure they were on the firmest legal ground possible.

When can we expect approval for vaccines for children under 12?

With school starting back, many parents are anxious to know when their children will be eligible for a vaccine. Yesterday’s full approval only applies to individuals 16 and up. But children aged 12-16 can are still eligible under the emergency authorization.

However, Dr. Collins says that parents with children under 12 will likely have to wait until early 2022 for even emergency use authorization.

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INTERNATIONAL NEWS

Taliban says it is now stopping Afghans from going to Kabul airport

Since August 14, the US has evacuated about 58,700 people from Afghanistan, 21,600 of them during a 12-hour span on Monday. It’s hard to get an exact breakdown, but this number includes American citizens and third-country nationals, as well as NATO’s Afghan allies and assorted refugees. Those numbers are quite astonishing, considering the chaotic scenes at airport, and widespread reports of the Taliban preventing many Afghans from even reaching the airport.

There has been much controversy surrounding President Biden’s Aug. 31 deadline to wrap up US military operations at the airport. Biden participated in a virtual G7 summit today in which other world leaders pressured him to go beyond that deadline. The Taliban have warned of “consequences” should the US remain beyond the Aug. 31 deadline. Biden so far has given no indication that he plans to keep the US’ 5000 or so troops there beyond the end of this month. However, he will be making another address on the progress of the evacuation today.

“We are not in favor of allowing Afghans to leave”

Taliban spokesman Zabihullah Mujahid said today that the Taliban will no longer allow Afghan nationals to evacuate from Kabul airport. White House Press Secretary Jen Psaki presumes this prohibition does not apply to US Afghan allies with Special Immigrant Visas, but this was not clear from Mujahid’s statement.

Some media reports stated they were not allowing Afghans to leave at all, but that is not the case. Mujahid said that “We are not in favor of allowing Afghans to leave”. That was part of a statement in which he asked the US not to encourage Afghans, including doctors, engineers, and elite military personnel, to leave the country.  He also said “we are not going to allow Afghans to leave and we will not extend the deadline”. But in that context, he was clearly talking about the airport.

Mujahid said “The way to the airport has been closed now. Afghans are not allowed to go there now. Foreigners are allowed to go but we have stopped Afghan nationals to go because [of the crowding]. There is danger that people will lose their lives. There might be a stampede”. The Taliban is clearly anxious to clear the way for the few thousand American citizens still in Kabul so the US military doesn’t extend its stay in the country.

Mujahid went on to accuse US soldiers of shooting at people when crowds became too intense. There have been reports of recent firefights and resulting civilian deaths, but it’s not clear who the shooters were. In any case, it’s generally safe to take anything the Taliban say with a grain of salt.

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