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The US Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have called a temporary halt to the use of Johnson & Johnson’s COVID-19 vaccine while they conduct a review, following six reports of rare blood clots.
CDC said it will convene a meeting of its Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance, with FDA subsequently reviewing that analysis.
As of April 12, more than 6.8 million doses of the single shot Johnson & Johnson vaccine have been administered in the US.
The six blood clots are similar to those seen with AstraZeneca’s vaccine in Europe. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” the joint CDC/FDA statement said.
After concluding that very rare blood clotting events are linked to the AstraZeneca COVID-19 vaccine, the EMA safety committee has now started a review of reports of blood clots in people who have received the Johnson & Johnson vaccine.
Four serious cases of unusual blood clots with low blood platelets have been reported following vaccination with Johnson & Johnson’s product, one in a clinical trial and three cases occurring in the vaccine rollout in the US. One of them was fatal.
The Johnson & Johnson vaccine is currently only available in the US, but was authorised in the EU on 11 March 2021. Vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.
EMA said the reports of blood clots – which have the same unusual presentation as those seen with the AstraZeneca vaccine - point to a “safety signal” but it is currently not clear whether there is a causal association.
The agency also announced its started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated the AstraZeneca vaccines. There have been five cases of the very rare disorder, which is characterised by leakage of fluid from blood vessels, causing tissue swelling and a drop in blood pressure.
The European Medicines Agency’s safety committee has concluded that unusual blood clots are a very rare side effect of AstraZeneca’s COVID-19 vaccine, but said the benefits of using it still far outweigh the risks.
It is not recommending any restrictions on who should receive the vaccine, saying there is no evidence of any specific risk factors, including any greater risk for women, or for younger age groups.
The safety committee carried out a review of 62 cases of blood clots in the brain and 24 cases of clots in the abdomen, reported in the EU drug safety database, as of 22 March 2021. Of these, 18 cases were fatal. Around 25 million people had received the AstraZeneca vaccine at this point.
There is now more data to review, with a total of 169 cases of brain clots and 53 cases of abdominal clots reported up to 4 April. Around 34 million people had been vaccinated in Europe (including the UK) by this date. EMA said the more recent data do not change the recommendations.
EMA is sending out a message to healthcare professionals and people receiving the vaccine to be aware of the possibility of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination, setting down the symptoms and the particular features of the clots. The agency said the condition can be treated if the signs are recognised and appropriate drugs are given.
“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” EMA said.
It will be up to member states to decide what action to take, depending on the pandemic situation and vaccine availability. Denmark, Netherlands and Latvia have stopped using the AstraZeneca vaccine, while others including France, Spain and Germany, are restricting its use to older people.
EMA has commissioned new studies and amendments to ongoing research to try and undercover the mechanisms behind the blood clots.
The UK’s Medicines and Healthcare products Agency stopped short of saying there is a causal link in its review of 79 cases of rare blood clots that have caused 19 deaths in the country. The link is stronger than seen previously, but not proven, and more research is needed, MHRA said.
MHRA is also updating its guidance to healthcare professionals to make them aware of the rare adverse events, but maintains the benefits are greater than the risks.
However, the Joint Committee on Vaccination and Immunisation (JVCI), which advises the UK government on the COVID-19 vaccines programme, said the risk/benefit profile for younger people has shifted as a result of the review. It changed its recommendations to say healthy people aged 18 – 29 should be offered an alternative to the AstraZeneca vaccine.
The French biotech company Valneva has announced positive data for the first part of the phase I/II clinical trial of its COVID-19 vaccine and said it plans to commence a phase III trial by the end of this month.
The phase I/II study, funded by the UK government, tested three different doses of the vaccine, which consists of whole, inactivated SARS-CoV-2 virus and an adjuvant to boost the immune response. Based on the data, Valneva has decided to advance the high dose into the phase III clinical trial.
The vaccine was generally safe and well tolerated across all doses, with no safety concerns identified by an independent safety monitoring board. More than 90% of all study participants developed significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested and the vaccine also induced broad T-cell responses.
The aim is to complete phase III and apply to the UK regulator, the Medicines and Healthcare products Regulatory Agency, for approval of the vaccine in the autumn 2021. Valneva said discussions with other regulatory bodies are ongoing.
Thomas Lingelbach, CEO of Valneva, said, “Given the potential advantages often associated with inactivated whole virus vaccines, we believe that [our vaccine] has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process.”
In addition to funding the clinical trial, the UK government has invested money in Valneva’s manufacturing facility in Livingston, Scotland, where the inactivated virus is produced. The manufacturing process has already been upscaled to final industrial scale. From Scotland, the bulk material will go to the company’s plant in Solna, Sweden, where it will be put into vials.
In September 2020, Valneva struck a deal with the UK government to supply 60 million doses at a cost of €470 million. They were due to be delivered this year, but announcing the phase I/II results Valneva said the timeline for delivery will now extend into 2022.
Last month the UK government announced it would begin a revaccination campaign in the autumn, in an attempt to ensure protection from COVID-19 infection conferred by the current vaccination programme is maintained. Valneva said continues to work closely with the government to review plans, including meeting the UK’s booster campaign requirements, and on the potential development of a vaccine that is effective against emerging variants of the SARS-CoV-2 virus that threaten to undermine the effectiveness of existing vaccines.
Pfizer and BioNTech announced that their COVID-19 vaccine showed 100% efficacy and robust antibody responses in a phase III trial in adolescents 12 to 15 years of age. The results exceed those recorded earlier in participants aged 16 to 25 years old.
These are the topline results from a phase III trial involving 2,260 adolescents, who had not previously been infected with SARS-CoV-2.
“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, CEO of Pfizer. The data will be submitted to regulators in the coming weeks, “With the hope of starting to vaccinate this age group before the start of the next school year,” Bourla said.
The trial enrolled 2,260 adolescents 12 to 15 years of age in the US. There were 18 cases of COVID-19 in the placebo group and none in the vaccinated group. Vaccination elicited SARS-CoV-2–neutralizing antibody, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well with the response seen in participants aged 16 to 25 years old. The vaccine was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.
The companies plan to submit the data to the FDA and EMA to request an amendment to the current approvals.
Last week, the first children were vaccinated in a global phase I/II/III seamless study to assess the safety, tolerability, and immunogenicity of the vaccine in children aged 6 months to 11 years of age.
GlaxoSmithKline (GSK) announced it will carry out fill and finish of up to 60 million doses of the COVID-19 vaccine developed by the US biotech Novavax that have been ordered by the UK government.
GSK will provide capacity at its facility in Barnard Castle in north east England, from May 2021, with rapid technology transfer between the two companies beginning immediately, the pharma company said on Monday.
The raw material for the Novavax vaccine is also produced in the region, by Novavax manufacturing partner, Fujifilm Diosynth Biotechnologies, at its site in Billingham.
The UK government has ordered 60 million doses of the vaccine under an advance purchase agreement with Novavax.
The UK Vaccine Taskforce has played a key role in enabling production of the Novavax vaccine in Europe, supporting clinical trials and manufacturing, and now arranging for GSK to do fill and finish.
Health minister Matt Hancock said, “We've all seen just how important onshore vaccine manufacturing capabilities are, and this fantastic deal will ensure more of these vital products can be produced here in the UK. The UK’s vaccination programme has been a national success, with over 30 million people now having received a first dose of a COVID-19 vaccine.”
The Novavax product has shown strong potential efficacy in phase III clinical trials, including against the B.1.1.7 variant of concern that is driving a third wave of infections in Europe.
It is expected Novavax will apply for approval from the UK Medicines and Healthcare products Agency during the next three months.
Following unprecedented public criticism from the US National Institute of Allergy and Infectious Diseases that the interim results of the US phase III trial of its COVID-19 vaccine published on Monday, were “outdated” AstraZeneca has rushed to complete the full primary analysis.
The results, published this morning show the vaccine has 76% efficacy in preventing symptomatic COVID-19 infections.
That is 3% lower than in the interim analysis, but is consistent with the interim result, given the range of possible values (confidence interval) of 68% to 82%.
AstraZeneca said the results have been presented to independent experts monitoring the trial who raised the concern that the data presented on Monday were incomplete. The primary analysis is pre-specified in the trial protocol and will be the basis for the company to apply for US Food and Drug Administration approval in the coming weeks, the company said.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca said, "The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for emergency use authorisation in the US and preparing for the rollout of millions of doses across America."
Results of the AstraZeneca US phase III trial of AZD1222, released this morning, show statistically significant vaccine efficacy of 79% in preventing symptomatic COVID-19 infections and 100% efficacy at preventing severe disease and hospitalisation.
The interim safety and efficacy analysis is based on 32,449 participants, in whom there were 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.
Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.
The vaccine was well tolerated, and the independent data safety monitoring board did not identify any safety concerns related to the vaccine. This included a specific review of blood clots and the more serious cerebral venous sinus thrombosis, which caused use of the vaccine to be suspended in Europe earlier this month.
Ann Falsey, professor of medicine at University of Rochester School of Medicine, who is co-lead principal investigator for the trial, said the findings reconfirm previous results. “This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”
Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca said the results add to the growing body of evidence showing the vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. “We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US emergency use authorisation,” he said.
The safety committee of the European Medicines Agency said the benefits of AstraZeneca’s vaccine in combating the still widespread threat of COVID-19 infection continue to outweigh the risk of side effects.
The vaccine is not associated with an increase in the overall risk of blood clots (venous thrombosis), while COVID-19 infection itself results in clotting problems that may be fatal. Overall, the number of thromboembolic events reported after vaccination, both in clinical trials before approval and after rollout of vaccination campaigns, was lower than that expected in the general population, EMA said.
There is also no evidence of a problem related to specific batches of the vaccine, or to particular manufacturing sites.
However, there remains a question over whether the vaccine may be associated with some very rare cases of specific types of thromboses. While around 20 million people in the EU and UK had received the AstraZeneca vaccine as of March 16, EMA has received reports of 25 such cases. The safety committee said a causal link with the vaccine is not proven, but on the basis of available evidence could not rule out a connection, and it will now carry out further analyses.
A warning about the possibility of rare clotting disorders will be added to the label on the vaccine and the patient information leaflet, but the safety committee said the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19 outweighs the extremely small likelihood of serious thromboses.
Germany, France, Italy and other EU countries that stopped using the AstraZeneca vaccine pending the safety review said they would resume its use.
Sewage monitoring needs to be included in national testing programmes for tracking SARS-CoV-2, as part of an update of testing strategies to detect mutated variants of the virus that may be more transmissible and/or cause more serious disease.
EU funding will be made available to support deployment, the analysis samples for the presence of variants and for the exchange of data, to inform preparedness and response measures.
The monitoring systems, to be in place no later than October 2021, should include all towns and cities with populations greater than 150,000, with minimum sampling frequencies of twice a week. The initiative is part of a common path to safe and sustained ending of lockdown measures published by the Commission on Wednesday.