# Exclusive-EU to decide on Pfizer booster on Oct. 4 – document Author: Pal Sinha, Barnali Author URL: https://financedigest.com/author/pal-sinha-barnali Published: 2021-09-30 Category: NEWS Category URL: https://financedigest.com/category/news Meta Title: EU to Decide on Pfizer Booster Vaccine Approval Meta Description: The EU's drugs regulator will decide on Monday whether to approve Pfizer's COVID-19 booster vaccine, potentially allowing for wider rollout across URL: https://financedigest.com/exclusive-eu-to-decide-on-pfizer-booster-on-oct-4-documenthtml ![undefined](https://prod.superblogcdn.com/site_cuid_cm5qst7v3003gwirgwqtxn8i8/images/2021-09-29t161742z1lynxmpeh8s108rtroptp4health-coronavirus-eu-boosters-1736837731031-compressed.jpg) By Francesco Guarascio and Emilio Parodi BRUSSELS (Reuters) – The EU’s drugs regulator will decide on Monday whether to approve Pfizer’s COVID-19 [booster](https://www.financedigest.com/ignoring-who-call-major-nations-stick-to-vaccine-booster-plans.html) vaccine, but it is unlikely to give precise guidance on who should receive it, according to an internal document and two officials. If the European Medicines Agency (EMA) gives its backing for the jab, the 27-member block would join the United States, Britain and Israel which have already received the green light to deploy [boosters,](https://www.financedigest.com/ignoring-who-call-major-nations-stick-to-vaccine-booster-plans.html) even though there is no consensus among scientists that they are necessary. On 4 [October the EMA will deliver an opinion on the need for Pfizer boosters for the general population,” EMA’s head](https://www.financedigest.com/euro-zone-october-pmi-adds-to-evidence-bloc-is-heading-for-recession.html "Euro zone October PMI adds to evidence bloc is heading for recession") Emer Cooke told EU lawmakers in an internal meeting on Tuesday, according to minutes of the discussion seen by Reuters. EMA was not immediately available for a comment. EMA has publicly said it would decide on Pfizer’s [booster](https://www.financedigest.com/ignoring-who-call-major-nations-stick-to-vaccine-booster-plans.html) at the start of October, but has never given a precise date. More than a dozen EU countries have already started administering [boosters without official EMA backing](https://www.financedigest.com/fda-advisers-back-the-same-covid-vaccine-for-initial-shots-boosters.html "FDA advisers back the same COVID vaccine for initial shots, boosters"). [Official approval will provide legal protection to those countries and may spur others to launch](https://www.financedigest.com/pega-pool-announces-the-official-launch-of-its-eco-friendly-bitcoin-mining-pool.html "PEGA Pool Announces the Official Launch of Its Eco-friendly Bitcoin Mining Pool") a booster programme to fight the more infectious Delta variant during the winter months. Two EU officials familiar with EMA’s decision-making processes said next week’s decision will focus on the booster’s safety and effectiveness, and will be broad in scope, meaning that it will not indicate precisely which age or [risk groups](https://www.financedigest.com/pizza-group-dp-eurasia-sharpens-turkish-focus-as-russia-risk-high.html "Pizza group DP Eurasia sharpens Turkish focus as Russia risk high") should receive it. That would be in line with EMA’s decisions on [vaccine boosters](https://www.financedigest.com/ignoring-who-call-major-nations-stick-to-vaccine-booster-plans.html "Ignoring WHO call, major nations stick to vaccine booster plans") for other diseases, such as tetanus. The approach would also be consistent with EMA’s earlier decisions in the [pandemic – for instance it largely left it up to member states to decide whether to restrict](https://www.financedigest.com/are-financial-pandemic-restrictions-coming-to-an-end.html "Are Financial Pandemic Restrictions Coming to an End?") vaccines in the face of potential side effects. The broad [guidance would allow](https://www.financedigest.com/guidance-for-transfer-of-nil-rate-inheritance-tax-allowance.html "Guidance for transfer of nil-rate Inheritance Tax allowance ") states to tailor the use of boosters to their national needs, without risking administering them beyond the instructions authorised by EMA – which would increase their legal risks. In August, EMA said there was not enough data to recommend using boosters, and the World [Health Organization](https://www.financedigest.com/explainer-how-the-world-health-organization-might-fight-future-pandemics.html "Explainer-How the World Health Organization might fight future pandemics") has called for a halt to boosters until more people around the world have been vaccinated. There is no need of boosters for the general population, but there is some waning effect, especially for the elderly,” Cooke told EU legislators, [according to minutes of Tuesday’s internal](https://www.financedigest.com/most-sales-and-marketing-teams-struggle-to-activate-data-in-their-organisation-according-to-new-international-study.html "Most Sales and Marketing teams struggle to activate data in their organisation, according to new international study") meeting. The wide guidance could amplify differences across EU states. Who gets a booster in the region is already fragmented. In Austria, Hungary and the Czech Republic, authorities are aiming for wider rollouts, whereas in other states only some more vulnerable people would receive boosters. The EU Commission has repeatedly warned that different [national policies on vaccines](https://www.financedigest.com/vaccine-deserts-the-poor-nations-trailing-in-the-fight-against-covid-19.html "Vaccine deserts: The poor nations trailing in the fight against COVID-19") can increase hesitancy. The EMA’s broad approach would also differ from other major Western countries. The U.S. Food and Drug Administration (FDA) last week recommended the Pfizer booster for those 65 and older, all people at high [risk of severe](https://www.financedigest.com/pfizer-says-antiviral-pill-cuts-risk-of-severe-covid-19-by-89.html "Pfizer says antiviral pill cuts risk of severe COVID-19 by 89%") disease, and others who are regularly exposed to the virus. In the United Kingdom, [boosters are being given to all adults](https://www.financedigest.com/uk-to-offer-covid-booster-to-all-adults-from-september.html "UK to offer COVID booster to all adults from September") aged 50 years or over, healthcare workers, and all those at high risk from COVID-19 or in close contact with immuno-suppressed individuals. MANY SPARE DOSES Scientists are divided over whether boosters are needed, because it is not yet completely clear how long protection lasts in people who have been fully vaccinated, the European Centre for Disease prevention and Control (ECDC) said. However, EU states have already bought additional [vaccines for boosters](https://www.financedigest.com/israels-covid-19-vaccine-boosters-show-signs-of-taming-delta.html "Israel’s COVID-19 vaccine boosters show signs of taming Delta"). They [agreed in May to buy at least 900 million](https://www.financedigest.com/iag-agrees-to-buy-80-stake-in-air-europa-for-400-million-euros.html "IAG agrees to buy 80% stake in Air Europa for 400 million euros") doses of the Pfizer and BioNTech vaccine. This came after the EU had already secured more than enough [shots for its entire population from Pfizer](https://www.financedigest.com/pfizer-biontechs-updated-covid-shot-shows-strong-response-against-bq-1-1.html "Pfizer/BioNTech’s updated COVID shot shows strong response against BQ.1.1") and other vaccine makers. Under the contract, EU governments are required to [buy the 900 million shots mostly from next](https://www.financedigest.com/britains-next-buys-failed-furniture-retailer-made-com-400-jobs-axed.html "Britain’s Next buys failed furniture retailer Made.com, 400 jobs axed") year, and could order another 900 million until 2023. Given that nearly 75% of the EU’s adult population has already been fully vaccinated, most of the additional Pfizer [doses would likely be needed only if administered as boosters](https://www.financedigest.com/jj-says-booster-dose-increased-antibodies-in-early-stage-studies.html "J&J says booster dose increased antibodies in early-stage studies"). An alternative would be to donate or sell them to poorer [nations who have not yet](https://www.financedigest.com/swiss-national-bank-says-inflation-battle-not-yet-won.html "Swiss National Bank says inflation battle not yet won") got enough doses. Some of the [vaccines could also be deployed on children](https://www.financedigest.com/germanys-vaccine-panel-says-one-covid-shot-enough-for-children.html "Germany’s vaccine panel says one COVID shot enough for children") or be used against potential new variants. Pfizer has [agreed to sell](https://www.financedigest.com/exclusive-repsol-agrees-to-sell-alberta-oil-assets-to-cppib-backed-teine-energy-sources.html "Exclusive-Repsol agrees to sell Alberta oil assets to CPPIB backed-Teine Energy -sources") the EU modified shots if needed. But the decision on when a new variant may be predominant and whether the existing [vaccine is not effective against it requires](https://www.financedigest.com/automakers-mandate-masks-at-all-u-s-plants-but-not-requiring-vaccines.html "Automakers mandate masks at all U.S. plants but not requiring vaccines") a complex procedure which makes it difficult to force Pfizer to provide an updated version, two people familiar with the contract told Reuters. Pfizer had no comment on the contract with the EU but the company’s boss [Albert Bourla has said that it can develop in less than 100 days](https://www.financedigest.com/its-culture-versus-commerce-on-liverpools-albert-dock-these-days.html "It’s culture versus commerce on Liverpool’s Albert Dock these days") updated versions of its COVID-19 vaccine, if new variants emerged. (Reporting by Francesco Guarascio @fraguarascio and Emilio Parodi;Editing by Josephine Mason, Elaine Hardcastle) --- This blog is powered by Superblog. Visit https://superblog.ai to know more. ---