The latest news on the Pfizer-BioNTech vaccine, between excess doses and adverse reactions

The latest news on the Pfizer-BioNTech vaccine, between excess doses and adverse reactions

In the United States, many anti-Covid vaccine vials would contain more doses than necessary and there are other reports of adverse reactions

(Image: Unsplash) After the approval by Mhra and Fda of the anti-vaccine Covid by Pfizer-Biontech, vaccination campaigns against the coronavirus have started in the United Kingdom and the US. And surprises - whether good or bad - run after each other. Here's what happened in the last few hours.

More Doses Than Expected

Pfizer vaccine comes in vials that pharmacists or healthcare professionals need to portion to get the right dosage to people. Each vial provided by the company officially contains sufficient material for 5 doses of the vaccine. From the early hours, however, in the United States they realized that many of the vials contained up to 2 extra doses. Under normal conditions, the excess product in a package would not be used, but discarded after the last official dose is taken (the fifth in this case). Only we are in a global health emergency and the rules can change. Hence, as Politico was the first to report, the FDA authorized operators to take advantage of all the extra doses of vaccine that may be contained in the vials. But be careful, the doses must be whole and it is forbidden to mix the leftover two or more vials to obtain an additional dose: in fact, you risk contamination.

Using these extra doses, the US media report, the supply vaccine could increase by up to 40%.

Pfizer, however, gets its hands on and, through spokesperson Sharon Castillo, warns: “The amount of vaccine remaining in the multidose vial after the removal of five doses can vary , depending on the type of needles and syringes used ". It does not confirm the advice of the FDA, referring operators to consult the policies of their reference institutions.

The US is also negotiating with Pfizer to purchase tens of millions of new vaccine doses for delivery as early as spring. The company, however, makes it known that it has not signed any agreement yet: first it must satisfy the contracts already signed with other countries for supplies and, although the level of production may be increased in the coming months, the bulk should arrive after the summer 2021.

Illustrious vaccinations

US President-elect Joe Biden and current Vice President Mike Pence are expected to receive their first dose of vaccine soon - a media operation to boost confidence of the population in Pfizer-Biontech drug safety. Pence and his wife, in favor of the camera, should receive the vaccine at the White House as early as Friday, while Biden, again publicly, within the next week.

Twitter meanwhile has announced that it is working to eliminate fake news and misinformation about the anti-Covid vaccines from the platform.

Other adverse reactions

The sore point of the last few hours is the news of other cases of serious adverse reaction to the vaccine. One episode is that of a US health worker, one of the first to receive the Pfizer-Biontech product in the country. The woman, who would not have a history of allergic or anaphylactic reactions, began to feel sick about ten minutes after the injection. Skin rashes, difficulty in breathing and tachycardia led clinicians to immediately give her a dose of epinephrine that buffered the manifestations. However, it seems that these have recurred and that it was necessary to resort to steroids and hospitalization in intensive care. An adverse reaction, therefore, very serious that endangered the person's life. Now, fortunately, the woman is well and - the media reports - she has not regretted the decision to get vaccinated against the coronavirus.

Another less serious case always presented itself in a health worker, who developed swollen eyes, throat irritation and dizziness after the vaccine. With due care, the problems were resolved within an hour.

These data continue to be useful precisely for what is called phase 4 of clinical research, or pharmacovigilance, which is once a drug has arrived on the market and allows you to monitor the risk / benefit ratio. Vaccines are in fact drugs with possible side effects, but experts reiterate that these effects are currently expected and should not discourage membership.

Meanwhile in Europe

The Agency European Union for Medicines (Ema) has shortened the process of discussing the data relating to the Pfizer-Biontech vaccine, whose approval could arrive on December 21, instead of 29.

"Vaccines against Covid-19 I'm on the horizon. EMA is working tirelessly to conclude its evaluation of the safety and efficacy of the vaccine from BioNTech and Pfizer, "commented the European Commissioner for Health Stella Kyriakides via social media. “I am pleased that the evaluation meeting has been brought forward to December 21st: time is of the essence, time saves lives.”

# COVID19 vaccines are on the horizon. @EMA_News is working around the clock to conclude its safety & efficacy assessment of the #BioNTech #Pfizer vaccine.

I welcome that meeting on assessment has been advanced to 21/12.

Time is of essence-time saves lives. #StrongerTogether

- Stella Kyriakides (@SKyriakidesEU) December 15, 2020

The countries of the Union, meanwhile, are preparing - who better, who worse - all launch of vaccination campaigns which should start at the same time in different member states. "Every day counts: we work at full speed to authorize vaccines against Covid-19 that are safe and effective", said the president of the European Commission Ursula von der Leyen on social networks. “The first Europeans are likely to be vaccinated before the end of 2020 ″.

Every day counts - we work at full speed to authorise # COVID19 vaccines that are safe & effective.

I welcome @EMA_News bringing forward its meeting to discuss the @ pfizer / BioNTech vaccine, before Christmas.

Likely that the first Europeans will be vaccinated before end 2020!

- Ursula von der Leyen (@vonderleyen ) December 15, 2020

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