{"id":10797,"date":"2023-03-02T15:30:25","date_gmt":"2023-03-02T21:30:25","guid":{"rendered":"https:\/\/www.voicesforvaccines.org\/?post_type=jtf_topics&p=10797"},"modified":"2024-08-10T15:35:56","modified_gmt":"2024-08-10T20:35:56","slug":"did-rsv-vaccine-clinical-trials-end-abruptly-for-safety-concerns","status":"publish","type":"jtf_topics","link":"https:\/\/www.voicesforvaccines.org\/es\/jtf_topics\/did-rsv-vaccine-clinical-trials-end-abruptly-for-safety-concerns\/","title":{"rendered":"Did RSV vaccine clinical trials end abruptly for safety concerns?"},"content":{"rendered":"
[vc_row source=”” text=”Clinical Trials” font_container=”tag:h2|text_align:left” use_theme_fonts=”yes” google_fonts=”font_family:Abril%20Fatface%3Aregular|font_style:400%20regular%3A400%3Anormal” link=”” css=”.vc_custom_1708910874436{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;}”][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=”The Claim:” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”][vc_column_text css=””]\n
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A\u00a0tweet<\/a> makes multiple claims about RSV vaccines, including the assertion that an alarming safety problem prompted GlaxoSmithKline (GSK) to abruptly end all clinical trials.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_custom_heading text=”The Facts:” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”][vc_column_text css=””]This tweet is an excellent example of a tactic common among anti-vaxxers: they conflate multiple study results with complex data, withholding and distorting information to blur important distinctions and amp up a single scary claim about perceived danger. The tweet in question makes multiple distinct claims. Our first task is to address each claim on its merits.<\/p>\n

Before we jump into the details, note that our tweeter lumps all the trials together, implying that all the different trial concerns are focused on \u201cthe RSV vaccine,\u201d as if there is only one. In fact, there are many different\u00a0RSV<\/a>\u00a0vaccine candidates from various manufacturers using different formulations that cover different populations.<\/p>\n

There are five distinct claims in this tweet; we\u2019ll address each one in turn.<\/p>\n

We\u2019ll begin with the claim that GSK shut down all RSV trials in response to a safety concern. This is not true. Currently, GSK has\u00a0more than two dozen trials<\/a>\u00a0that are ongoing, recently completed, recruiting, or about to start. It\u2019s true that a maternal vaccine trial was\u00a0stopped<\/a>\u00a0for a safety signal that has not been disclosed because study investigators are doing additional analysis. The trial halt demonstrates that safety protocols are working as intended. One purpose of clinical trials is to identify safety concerns before a vaccine is considered by the FDA. In this case, it appears the study investigators are following proper safety procedures.<\/p>\n

The second claim concerns one person who died in an RSV study of about 600 adults. Although it is true that one person in the study died, the vaccine did not cause their death. The investigators disclose the reason: toxicity from quetiapine and amlodipine. Quetiapine is an antipsychotic used to treat mood disorders. Amlodipine is a beta blocker, commonly prescribed to treat blood pressure. Quetiapine and amlodipine can\u00a0sometimes interact<\/a>\u00a0with serious consequences, especially if someone accidentally takes too much. Neither of these medications is in the vaccine.<\/p>\n

Then, our tweeter claims that Pfizer\u2019s RSV vaccine causes Guillain-Barre Syndrome. Although two Pfizer trial participants (out of roughly 20,000) were diagnosed with Guillain-Barre, these cases are very rare.\u00a0The two trial patients\u2019 Guillain-Barre syndrome symptoms resolved<\/a>\u00a0within three to six months,
\nand Pfizer is conducting a safety study.<\/p>\n

The fourth claim suggests that the RSV vaccine was fast-tracked by the FDA despite an early halt of\u00a0Pfizer\u2019s safety trials<\/a>. In fact, Pfizer did not stop \u201csafety trials\u201d early. Instead, Pfizer stopped enrollment for the trial \u2014 they stopped accepting new patients as the trial continued because they already had the data they needed to show that the vaccine was safe and effective. This is a reasonable resource-saving measure. If you have the data you need to submit a vaccine to the FDA, there\u2019s no reason to enroll additional people. Meanwhile \u201cpre-planned safety reviews\u201d throughout the trial showed \u201cno safety concerns for both the vaccinated individuals and their newborns.\u201d When the FDA reviews the safety data, it will be publicly available on the FDA website. It is true that the FDA fast-tracked Pfizer\u2019s maternal RSV vaccine\u2014back in 2018. It doesn\u2019t appear the FDA is rushing the vaccine to market.<\/p>\n

Only the final claim (that GSK and Pfizer vaccines use the \u201cexact same technology\u201d) contains more truth than fiction. Pfizer and GSK vaccines are both mRNA vaccines, so they do use the same technology. But there are still proprietary differences between them, so it is not correct to claim these vaccines are \u201cexactly\u201d the same.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

The tweet falsely claims that all RSV vaccine trials by GSK were abruptly ended due to safety concerns; in reality, only one trial was paused for safety analysis, and the rest are ongoing, with no single RSV vaccine being the focus of all concerns.<\/p>\n","protected":false},"parent":0,"template":"","jtf_topic_subjects":[188,217,218],"class_list":["post-10797","jtf_topics","type-jtf_topics","status-publish","hentry","jtf_topic_subjects-mrna-vaccines","jtf_topic_subjects-rsv","jtf_topic_subjects-vaccine-safety","entry","no-media"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/jtf_topics\/10797","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/jtf_topics"}],"about":[{"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/types\/jtf_topics"}],"version-history":[{"count":1,"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/jtf_topics\/10797\/revisions"}],"predecessor-version":[{"id":10801,"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/jtf_topics\/10797\/revisions\/10801"}],"wp:attachment":[{"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/media?parent=10797"}],"wp:term":[{"taxonomy":"jtf_topic_subjects","embeddable":true,"href":"https:\/\/www.voicesforvaccines.org\/es\/wp-json\/wp\/v2\/jtf_topic_subjects?post=10797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}