E.U. Agency Approves Pfizer Covid Vaccine
E.U. Agency Approves Pfizer Covid Vaccine
BRUSSELS — 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’s drug authority, the European Medicines Agency, 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 came 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.
Now that the agency has authorized the Pfizer-BioNTech vaccine, the European Commission, the executive arm of the European Union, is expected to grant formal approval for the decision later Monday. That would be the green light for Pfizer to start distributing vaccines across the region.
The commission hands over responsibility for this first load as the cargo departs Pfizer factories in Puurs, Belgium, and in Mainz, Germany, headed for European capitals, most likely on Thursday. The company, which declined to answer detailed questions about transportation plans for security reasons, will play an active role in vaccine transport and storage in each country.
From that point on, each of the bloc’s 27 member governments will be responsible for distributing the vaccine to its population in a manner that fits each country’s needs, priorities and capabilities.
The first Europeans are expected to be inoculated on Dec. 27, 28 and 29.
The pressure to get this right, and to do so quickly, has been mounting as the European Union and its members try a collective approach in a critical node in the fight against the pandemic. Most countries have been more nationalistic.
The European approach began with the decision this summer to pool negotiating capital and to empower the European Commission and a board of representatives from every member country to reach agreements with pharmaceutical companies working on vaccines.
There has been criticism that the European Union, like the United States, did not order enough doses of the Pfizer-BioNTech vaccine when given a chance. But from a financial perspective, it appears that the approach did benefit the bloc: It is paying less than the United States for the Pfizer-BioNTech vaccine.
In Germany, the bloc’s biggest economy and home to BioNTech, the decision to empower the European Commission to negotiate a deal has attracted criticism, with some arguing that the country would have been better off going it alone. But most bloc members are midsize countries or smaller, and for them, the approach made sense. (As the clock counts down to Brexit, some may also see a potent political message here, with the bloc showing that there is strength in unity.)
Still, if the process has been unified to this point, the rollout will now start to look quite different from country to country.
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
Germany plans to start immunizing people older than 80 and others who live in care homes on Sunday, a day or two after the 400,000 doses it has ordered are expected to arrive. The plan is for the first vaccinations to be carried out by teams of doctors visiting nursing homes. In the first weeks of January, hundreds of immunization centers set up in halls, gyms and theaters will open.
For many Germans, it was hard to see a vaccine developed by their own citizens win approval and start to be administered in Britain weeks before it was scheduled to arrive in their own country.
But the country’s health minister, Jens Spahn, has pushed back against criticism.
“It gives a lot of credence to trust and responsibility across Europe that we are doing this together,” Mr. Spahn told reporters last week. “ ‘We’ are stronger than ‘I’,” he said.
France, the region’s second-largest economy, will also start shots by the end of the month. But the authorities there face an added challenge: vaccine skepticism. A recent poll indicated that only 41 percent of those surveyed were planning to get the injections.
It has not been lost on health officials across Europe that the first vaccinations may carry outsize symbolic value in the campaign to rally weary and sometimes skeptical populations.
In Greece, the inoculation drive has been called Operation Freedom by a government eager to win over reluctant citizens. A recent opinion poll there suggested that three in 10 Greeks did not intend to be vaccinated, citing concerns about efficacy and safety, with another three in 10 saying that they were skeptical.
In Italy, Alessio D’Amato, the top health care official in the Lazio region, which includes Rome, told the Italian newspaper Corriere della Sera that the first person to be vaccinated there “will be a nurse and will be a woman — just like in New York.”
As yet, no E.U. country has announced plans to make the vaccine mandatory.
And while there is pressure to vaccinate the most people in the least amount of time, experts warn that the authorities should not move too fast, especially if they are not confident in their countries’ infrastructure.
“The best approach, especially if there are concerns with the logistics, is to go slowly and steadily,” said Prof. Jean-Michel Dogné of the University of Namur, Belgium, an adviser to the European Medicines Agency.
“Nothing worse can happen than vaccinating someone with a vaccine that we can’t guarantee the quality for,” he said.
The biggest challenge for any country, Professor Dogné said, will be to track the temperature of the Pfizer-BioNTech vaccine throughout its journey from factory to injection.
The inoculation campaign will get going in earnest in the European Union in the first quarter of 2021, and most governments hope to have large swaths of their populations vaccinated by June.
Pfizer and the European Commission say they are working on a specific schedule for future vaccine deliveries but have not offered details. Revving up production is a challenge for the company, which is serving multiple clients, and European governments have expressed worry that the supply could become a trickle.
Professor Dogné said that was all the more reason to get it right and to make sure that none of the precious doses were squandered.
“This is an unprecedented operation,” he said. “We mustn’t waste a drop.”
Reporting was contributed by Melissa Eddy from Berlin, Aurelien Breeden from Paris, Emma Bubola from Rome, Monika Pronczuk from Warsaw, Niki Kitsantonis from Athens, and Raphael Minder from Madrid.