Virus World

European Union countries can use Pfizer's antiviral COVID-19 pill Paxlovid early after diagnosis of an infection even though its full review for regulatory approval has not been completed, the bloc's drugs regulator said on Thursday. Patients at risk of suffering severe forms of the infection should start the five-day course of Paxlovid as soon as possible after diagnosis or within 5 days of symptom onset but not when supplemental oxygen is already required. "The Agency's advice can now be used to support national recommendations on the possible use of the medicine before marketing authorisation," the European Medicines Agency (EMA) said in a statement.  EMA has given such clearances before for some antibody-based injectable drugs as governments scramble to boost their arsenal to fight the new Omicron variant. Omicron has likely grown resistant to some of those antibody drugs already. read more

Faced with rising coronavirus cases in the region, the EU regulator took similar action with Merck's molnupiravir pill in November. It advised it should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening. read more  Data released this week showed Pfizer's pill was nearly 90% effective in preventing hospitalisations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron. read more  The EU is still in talks to buy the Merck and Pfizer drugs. It is not clear when, or if, the European Commission will launch joint procurements for these drugs and how many states will buy supplies through the EU scheme or individually. Pfizer said on Tuesday it expected authorisation from the U.S. Food and Drug Administration and other regulatory agencies soon. read more  The decisions come as the region struggles to tame a spike in infections, which threatens to overwhelm healthcare systems and as the rapid spread of Omicron has prompted some governments to reimpose restrictions ahead of the Christmas holidays. read more

EMA Press Release (Dec. 16, 2021) available here  :

https://www.ema.europa.eu/en/news/ema-issues-advice-use-paxlovid-pf-07321332-ritonavir-treatment-covid-19 

The European Union drugs regulator has recommended granting Moderna's Covid-19 vaccine a conditional marketing authorization, a move that will soon pave the way for the drug to become the second coronavirus vaccine to be distributed in the bloc.  Following the recommendation by the European Medicines Agency (EMA), the shot now must be formally authorized by the European Commission, which is expected to do so quickly. On Wednesday, the European Parliament Committee on Environment, Public Health and Food Safety said on Twitter that they are "expected to follow the (EMA) recommendation and grant the authorization shortly after which the roll-out of the vaccine in the EU can begin. "Emer Cooke, EMA executive director, said on Wednesday that "this vaccine provides us with another tool to overcome the current emergency."  "It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO," she said. Ursula von der Leyen, president of the European Commission, said in a tweet that the EMA had found that the Moderna vaccine is "safe and effective" and that their decision is "Good news for our efforts to bring more #COVID19 vaccines to Europeans!" "Now we are working at full speed to approve it & make it available in the EU," she said. The EU has secured the purchase of up to 160 million doses of the Moderna vaccine -- enough to vaccinate 80 million people of its 448 million citizens -- as part of a joint vaccine strategy aimed to ensure equitable access across the bloc.  It has also purchased up to 300 million doses of the Pfizer/BioNTech vaccine, which was authorized for use on December 21 and rolled out to all EU countries days later.

In a landmark collective undertaking, the bloc is poised to start distributing shots to all 27 member nations and their 410 million citizens.  From Stockholm to Athens and from Lisbon to Warsaw, European Union governments are gearing up to receive a coronavirus vaccine later this week, even as cases keep rising in some parts of the continent. The bloc formally approved the Pfizer-BioNTech vaccine on Monday, setting off a logistical marathon the likes of which most of the authorities in the region have not had to contend with before. The operation to buy, approve and distribute the shots across the European Union has been complex and politically charged, and the stakes could not be higher. The pandemic’s second wave is still raging in parts of the region, most Europeans are spending the holidays in some type of lockdown, and the bloc’s economies are in tatters. To further complicate matters, a highly contagious variant in England led many European countries over the weekend to block travelers from Britain, although scientists say it has already reached the continent. If the vaccine mission is successful, it may bolster the credentials of the European Union, establishing its administration as a real force with executive powers and capabilities that can take on important tasks on behalf of its members. If not, the failure may spread acrimony and disaffection.

The European Medicines Agency, the bloc’s drug authority, gave its approval on Monday, after coming under intense scrutiny for the pace at which it reviewed the Pfizer-BioNTech vaccine. Britain granted the vaccine emergency approval weeks ago and then started rolling out its inoculation program, with the United States following not far behind. In the end, the European agency decided to speed up the process, moving forward an approval meeting that had been set for Dec. 29. The United States has also approved a vaccine from Moderna, but the European agency will not address the application for authorization of that company’s shots until Jan. 6. The agency’s authorization for the Pfizer-BioNTech vaccine was followed a few hours later by the final step, when the European Commission, the executive arm of the European Union,gave its approval, giving the green light for Pfizer to start distributing vaccines across the region.  “As we have promised, this vaccine will be available for all European countries at the same time, under the same conditions,” said Ursula von der Leyen, the European Commission president. “Let me say how proud I am that the first Covid vaccine available in Europe is a true product of the European innovation.”

It comes after a review of all currently available evidence into extremely rare cases of unusual blood clots in some vaccinated people.

• The Oxford-AstraZeneca shot has been dogged by safety concerns in recent weeks, with several European countries briefly suspending their use of the vaccine last month.
• The World Health Organization, the U.K.’s medicines regulator and the International Society on Thrombosis and Hemostasis have all said that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks.
• AstraZeneca has previously said its studies have found no higher risk of blood clots as a result of its vaccine.

LONDON — Europe’s medicines regulator on Wednesday announced a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford and rare blood clotting issues in adults who received the shot. It comes after a review of all currently available evidence into extremely rare cases of unusual blood clots in some vaccinated people. The Oxford-AstraZeneca shot has been dogged by safety concerns in recent weeks, with several European countries briefly suspending their use of the vaccine last month. The European Medicines Agency said on March 31 that it had found the shot to be safe and effective, but added it could not rule out the possibility of a causal link between the vaccine and clotting events so would continue to investigate. The World Health Organization, the U.K.’s medicines regulator and the International Society on Thrombosis and Hemostasis have all said that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks. AstraZeneca has previously said its studies have found no higher risk of blood clots as a result of its vaccine. Most countries have since resumed use of the shot but many have suspended inoculations across certain age groups. A senior official at Europe’s medicines regulator reportedly said Tuesday that there is a clear “association” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, though the direct cause was not yet known. In an interview with Italian newspaper Il Messaggero published Tuesday, Marco Cavaleri, chair of the EMA’s vaccine evaluation team, said: “In my opinion we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction.” The EMA subsequently denied it had established any link between the Oxford-AstraZeneca shot and rare blood clots in a statement to Agence France-Presse.

UK vaccine trial in children paused

The European Medicines Authority (EMA) will most likely not be able to approve the COVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January, the watchdog's Deputy Executive Director Noel Wathion said. 

AMSTERDAM (Reuters) - The European Medicines Authority (EMA) will most likely not be able to approve the COVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January, the watchdog’s Deputy Executive Director Noel Wathion said. “They have not even filed an application with us yet”, Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday. European regulators have only received some information about the vaccine, Wathion said. “Not even enough to warrant a conditional marketing licence”, he said. “We need additional data about the quality of the vaccine. And after that, the company has to formally apply.” This made it “improbable” that an approval could already be granted next month, Wathion said. The EMA could not be reached for comment.  AstraZeneca told Reuters last week that its COVID-19 vaccine should be effective against the new coronavirus variant, adding that studies were under way to fully probe the impact of the mutation. It has submitted a full data package about its vaccine to the British medicines regulator, British health minister Matt Hancock said.

BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process. The EMA uses rolling reviews to start assessing data on an experimental candidate before all the evidence needed to make a final decision is available, cutting the time it takes to decide whether to approve a prospect once the pivotal clinical trial results are submitted to the agency. The pressing need for COVID-19 vaccines potentially makes the mechanism important to the current crisis. After receiving the first part of a rolling submission, the EMA’s Committee for Medicinal Products for Human Use has begun evaluating the preclinical evidence on mRNA vaccine BNT162b2. The rolling review format provides opportunities to file additional data before the complete application. Each cycle typically requires a two-week review. The duration of the review of the final application will depend on the proportion of data already assessed by EMA under the rolling review. 

The EMA accepted BNT162b2 for rolling review on the strength of the preclinical and early clinical data on the vaccine. BioNTech and Pfizer have linked BNT162b2, which encodes a SARS-CoV-2 spike glycoprotein, to antibody and T-cell responses in people dosed in early-phase trials. The data led the partners to start a phase 3 clinical trial. That trial has now enrolled around 37,000 participants at sites in countries including the U.S., Brazil, South Africa and Argentina, with centers in Turkey coming online to help push BioNTech and Pfizer to their enrollment target of 44,000 subjects. More than 28,000 participants have received their second dose. BioNTech and Pfizer originally planned to enroll 30,000 subjects. The enrollment figures suggest BioNTech and Pfizer are closing in on the release of top-line data from the trial. Exactly how long the partners need to wait for efficacy data will depend on the extent to which participants have been exposed to the virus and the effectiveness of the vaccine. BioNTech and Pfizer are set to perform interim efficacy analyses when there are 32, 62, 92 and 120 COVID-19 cases in the trial...