Pfizer-BioNTech said on Monday they have submitted early stage clinical trial data to the Food and Drug Administration (FDA), seeking authorization of a Covid-19 vaccine booster for 16-year-old and older. They said the third dose showed significantly higher neutralizing antibodies compared to two doses against the initial SARS-CoV-2 virus, as well as against Beta and Delta variants.
The American pharmaceutical Pfizer and the German biotech company BioNTech said the results were based on a phase one trial, where participants received a third dose – “BNT162b2” – of the two-dose vaccine about eight months after receiving their second jab. The drugmakers said late-stage trial results evaluating the third dose are expected shortly.
Meanwhile, Pfizer-BioNTech also said trial data will be submitted to the European Medicines Agency and other regulatory authorities worldwide in the coming weeks. The announcement comes after the U.S regulators authorized a booster shot of Covid-19 vaccines by Pfizer and Moderna last Friday for Americans with weakened immune systems.
That means besides immune-compromised people who could not produce a sufficient immune system even after two doses of a Coronavirus vaccine, such as cancer and HIV patients, healthy people will also receive the booster shot. Pfizer has admitted that its vaccine’s efficacy drops over time, after Israel’s study shows the vaccine is just 39% effective against Delta variant.
According to two reports posted on medRxiv earlier this month (August 8), the Pfizer-BioNTech vaccine may be less effective than Moderna’s against the Delta variant. And the difference is huge. In a study of more than 50,000 patients in the Mayo Clinic Health System, researchers found Moderna’s effectiveness against Covid infection had dropped to 76% in July from 86% in early 2021.
On the other hand, over the same period, the effectiveness of the Pfizer-BioNTech vaccine had dropped to 42% from 76%. Obviously, Moderna vaccine appears to be better at fighting the Delta variant during the period when the U.S. CDC (Centers for Disease Control and Prevention) revealed on July 20 that the Delta made up an estimated 83% of the U.S. cases.
The Food and Drug Administration, who says fully vaccinated Americans do not need additional shots at this time, is under pressure to further protect people who had received two doses from the highly infectious Delta infection, which is as contagious as chickenpox. Last month, Israel announced that people over 60 in the country will be offered a third jab or booster shot.
On Monday (August 16), the CDC (Centers for Disease Control and Prevention) too recommends that people whose immune systems are compromised moderately to severely should receive an additional dose of mRNA Covid-19 vaccine after the initial 2 doses. It says the booster shot should be administered at least 28 days after a second dose of Pfizer-BioNTech or Moderna Covid-19 vaccines.
Now, to ensure lasting protection, sources said the U.S. may recommend Covid-19 vaccine boosters for all Americans – regardless of age – after 8 months since their second dose. Dr. Francis Collins, director of the National Institutes of Health, said on Sunday that the U.S. could decide in the next couple weeks whether to offer booster shots to Americans this fall.
Daily cases have jumped to more than 250,000 in the U.S., where Delta is responsible for more than 83% of Covid-19 infections since last month. Even though more than 198 million Americans have received at least one dose of a Covid-19 vaccine and more than 168 million are fully vaccinated, a fourth wave of infections has started due to Delta.
However, if the U.S. decides that a third dose is needed, it will create another mad rush for vaccines around the world. The White House has claimed that the nation has enough domestic supply to deliver boosters to Americans, even though the U.S. has begun sharing more than 110 million vaccine doses with the world after being criticised for hoarding Covid-19 vaccines.
But the WHO (World Health Organization) has urged wealthier, well-stocked and more-vaccinated countries to hold off on booster shots to ensure sufficient supply of first doses for people in the developing world. In the U.S., mix and match for booster jab is not recommended. The CDC says people who received either Pfizer-BioNTech or Moderna’s Covid-19 vaccine should get a third dose of the same mRNA vaccine.
In certain countries like the United Arab Emirates (UAE), a booster shot against Covid-19 to all fully vaccinated individuals has started as early as June for those initially immunised with a vaccine developed by the China National Pharmaceutical Group (Sinopharm). The UAE has had one of the world’s fastest vaccination programmes, with Sinopharm and Pfizer-BioNTech being the two vaccines mostly available.
Interestingly, mix and match for the booster jab is allowed in the UAE. If you live in Dubai and are fully vaccinated with Sinopharm, you can take a booster shot of Pfizer-BioNTech three months after your last Sinopharm dose. However, according to the Dubai Health Authority, only certain groups are eligible – UAE citizens, domestic helpers working for UAE citizens, and residents aged 50 and older.
It’s a different story in Abu Dhabi, where fully-vaccinated residents need to wait for six months after their last Sinopharm dose and can choose between a Pfizer-BioNTech or Sinopharm booster. According to health authorities, one Pfizer shot is sufficient as a booster, but in some cases two doses of booster shots can be administered with a doctor’s consent.
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- 3 Coronavirus Variants Discovered – Surprisingly, “Type-A” Found In Americans, Wuhan’s Type-B And Type-C In Europe
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August 17th, 2021 by financetwitter
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